New Testing

LABCORP DIAGNOSTICS

Seasonal Respiratory

Viruses and COVID-19

Testing To Detect Multiple Respiratory Infections,

Including COVID-19 and Flu, to Inform Treatment Options

COVID-19 during respiratory virus season may

create unprecedented health care challenges.

Chief among these is a differential diagnosis in the

presence of symptom overlap that exists between

colds, respiratory syncytial virus (RSV), influenza

(flu), and COVID-19.

There are important implications in knowing

whether symptoms are caused by influenza,

COVID-19 or both. 1

• Risk factors for more severe disease overlap:

age, obesity, residents in congregate settings,

underlying conditions of chronic lung disease,

cardiac disease, advanced liver disease,

chronic kidney disease 1-4

• Treating patients with influenza as though

they have COVID-19 may delay administration

of effective antivirals for influenza. 1

• Mitigation efforts for influenza are not as strict

as those for COVID-19. 1

• Distinguishing between influenza and

COVID-19 is important to disease surveillance

activities. 1

Symptoms

*These symptoms are considered rare, slight or uncommon. 1

Cold 5 RSV 6 Flu 2,5 COVID-19 2

Cough • • • •

Difficulty breathing, shortness

of breath • •

Chest tightness, discomfort • •

Wheezing

•

Runny nose; stuffy nose • • • •

Sneezing • •

Fatigue • • •

Headache •* • •

Body aches, muscle aches •* • •

Fever •* • • •

Sore throat • • •

Chills •* • •

New loss of taste, smell

•

The 2018 guidelines from the Infectious Diseases Society of America (IDSA) recommend

utilization of molecular assays to assess respiratory symptoms in patients suspected of having

influenza and/or RSV. 7 PCR has been endorsed as the test of choice for COVID-19 by IDSA, the

Centers for Disease Control and Prevention, and the World Health Organization. 8-10

Labcorp offers the following tests to help support a differential

diagnosis in patients presenting with respiratory symptoms.

Test Name Test No. SARS-CoV-2

2019 Novel Coronavirus (COVID-19), NAA 139900 •

Influenza A +

Influenza B

RSV

2019 Novel Coronavirus (COVID-19) with Influenza A, Influenza B and

Respiratory Syncytial Virus, NAA

140140 • • •

2019 Novel Coronavirus (COVID-19) with Influenza A and Influenza B 140147 • •

Influenza A, Influenza B and Respiratory Syncytial Virus, NAA 140163 • •

Influenza A and Influenza B, NAA 140165 •

2019 Novel Coronavirus (COVID-19) with Respiratory Syncytial Virus, NAA 140172 • •

Labcorp’s COVID-19 PCR test has not been FDA cleared or approved, has been authorized by FDA under an Emergency Use

Authorization (EUA), and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other

viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the

authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)

(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

References

1. Solomon DA, Sherman AC, Janjilai S. Influenza in the COVID-19 Era. JAMA Online August 14, 2020: E1-E2. https://jamanetwork.com. Accessed August 21, 2020.

2. Centers for Disease Control and Prevention. What is the difference between Influenza (flu) and COVID-19? August 31, 2020. https://www.cdc.gov/flu/symptoms/flu-vscovid19.htm.

Accessed September 10, 2020.

3. Centers for Disease Control and Prevention. People at high risk for RSV. June 26, 2018. https://www.cdc.gov/rsv/high-risk/index.html. Accessed September 10, 2020.

4. Centers for Disease Control and Prevention. COVID-19: Nursing homes & long-term care facilities. June 25, 2020. https://www.cdc.gov/coronavirus/2019-ncov/needextra-precautions/people-in-nursing-homes.html.

Accessed September 10, 2020.

5. Centers for Disease Control and Prevention. Cold versus flu. August 31, 2020. https://www.cdc.gov/flu/symptoms/coldflu.htm. Accessed September 18, 2020.

6. Centers for Disease Control and Prevention. RSV symptoms. June 26, 2018. https://www.cdc.gov/rsv/about/symptoms.html. Accessed September 18, 2020.

7. Uyeki TM, Bernstein HH, Bradley JS et al. Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment,

Chemoprophylaxis and Institutional Outbreak Management of Seasonal Influenza. Clin Infect Dis. 2019:68(6):e1-47.

8. Infectious Diseases Society of America. Guidelines on the Diagnosis of COVID-19. May 6, 2020. https://www.idsociety.org/globalassets/idsa/practice-guidelines/

covid-19/diagnostics/idsa-covid-19-guideline_dx_version-1.0.1.pdf. Accessed September 18, 2020.

9. Centers for Disease Control and Prevention. Interim guidance for rapid antigen testing for SARS-CoV-2. September 4, 2020. https://www.cdc.gov/coronavirus/2019-ncov/

lab/resources/antigen-tests-guidelines.html. Accessed September 18, 2020.

10. World Health Organization. Laboratory testing for coronavirus disease (COVID-19) in suspected human cases. Interim guidance 19 March 2020. https://apps.who.int/

iris/bitstream/handle/10665/331509/WHO-COVID-19-lab_testing-2020.1-eng.pdf. Accessed September 18, 2020.

Visit the online Test Menu at Labcorp.com for full test information,

including CPT codes and specimen collection requirements.

©2021 Laboratory Corporation of America® Holdings All rights reserved. L24604-0721-2

DIA GNOS TIC S F OR

NEUROLOGICAL DISORDER S

Enabling better patient

journeys for suspected

neurological conditions with

Neurofilament Light Chain

(NfL) testing

Objective evidence of neuronal damage

Neurofilament Light Chain (NfL) is a well-studied blood

biomarker test that is now widely available through

Labcorp for assessing neuronal damage from

neurodegenerative diseases and sports- related

concussion. Labcorp is committed to developing and

delivering innovative testing solutions to help support

the evaluation and diagnosis of neurological disorders

and diseases. NfL is our latest offering to support you in

delivering meaningful insights to your patients faster.

Neuron

AXON

Evaluating patients with suspected

neurological disorders can be

challenging. NfL testing can provide

the necessary objective evidence

that:

• Increases your confidence in referring

patients to a neurologist.

• Empowers you to give patients and their

families better answers faster.

NEUROFILAMENTS

Neurofilment light chain is a neuron specific protein

that lines that axons of healthy neurons.

NfL at a glance

Neurofilament light chain (NfL) is a neuron-specific

protein routinely released into the extracellular space.

Serum NfL levels rise above baseline in response to

neuronal injury and neurodegeneration. NfL has been

widely studied

for various conditions 1 , and can be helpful for

assessing patients for:

• Alzheimer’s Disease and other

neurodegenerative dementias: In symptomatic

patients with subjective memory decline, NfL

provides direct evidence for and can be a

predictor of clinical progression 2 .

• Concussion recovery: NfL can be used, in

conjunction with clinical observation, as a

primary biomarker to assess return to play in

concussed athletes 3-5 .

• Neurodegenerative diseases like Amyotrophic

Lateral Sclerosis (ALS) 6,7 , Multiple Sclerosis 1,8 ,

Parkinson’s Disease 9,10 , and Spinocerebellar

Ataxias 11 . In each of these, NfL, has been a

predictor of disease progression.

Labcorp Neurology

Our goal is to be your clinical and scientific

partner in neurology. If you have an idea for a study

utilizing NfL, we’d like to partner with you.

Test No.

Test Name

140455 Neurofilament Light Chain (NfL), Serum

For more details regarding specimen collection and test details, visit labcorp.com/test-menu.

Test Interpretation

NfL levels in healthy patients are

known to increase with age 12,13 .

Labcorp has established reference

intervals by age groups to facilitate

interpretation of NfL results.

----------------------------------------

Ø Red Top:

1ml

Ø Storage: Room

Temperature

Ø Turn Around Time: 1-3

days

Ø Test Code: 140455

Ø Client Price: $199

Ø Patient Price: $366

References

1. Khalil M, Teunissen CE, Otto M et al. Neurofilaments as biomarkers in neurological disorders. Nat Rev Neurol. 2018; 14(10):577-589.

2. Ebenau J, Pelkmans W, Verberk IMW, et.al. Association of CSF, Plasma, and Imaging Markers of Neurodegeneration With Clinical Progression in People With Subjective Cognitive Decline. Neurology.

2022, Publish Ahead of Print, DOI: 10.1212/WNL.0000000000200035.

3. Shahim P, Tegner Y, Marklund N, et.al. Neurofilament light and tau as blood biomarkers for sports-related concussion. Neurology. 2018; 90:e1780-e1788.

4. McDonald SJ, O’Brien WT, Symons GF, et.al. Prolonged elevation of serum neurofilament light after concussion in male Australian football players. Biomarker Research. 2021; 9:4.

5. Karantali E, Kazis D, McKenna J, et.al. Neurofilament light chain in patients with a concussion or head impacts: a systematic review and meta-analysis. European Journal of Trauma and Emergency

Surgery. 2021, 8 May. https://doi.org/10.1007/s00068-021-01693-1

6. Verde F, Steinacker P, Weishaupt JH, et al. Neurofilament light chain in serum for the diagnosis of amyotrophic lateral sclerosis. Journal of Neurology, Neurosurgery & Psychiatry. 2019; 90:157-164.

7. Feneberg E, Oeckl P, Steinacker P, et.al. Multicenter evaluation of neurofilaments in early symptom onset amyotrophic lateral sclerosis. Neurology. 2018; 90:e22-30.

8. Thebault S, Booth RA, Rush CA et al. Serum Neurofilament Light Chain Measurement in MS: Hurdles to Clinical Translation. Front Neurosci. 2021 Mar 25; 15:654942

9. Lin CH, Li CH, Yang KC et al. Blood NfL: A biomarker for disease severity and progression in Parkinson disease. Neurology. 2019; 93(11):e1104-e1111.

10. Halloway S, Desai P, Beck T, et.al. Association of Neurofilament Light With the Development and Severity of Parkinson Disease. Neurology. 2022; 98:e2185-e2193.

11. Wilke C, Mengel D, Schöls L, et.al. Levels of Neurofilament Light at the Preataxic and Ataxic Stages of Spinocerebellar Ataxia Type 1. Neurology. 2022; 98 e1985-e1996.

12. Hviid CVB, Knudsen CS, and Parkner T. Reference interval and preanalytical properties of serum neurofilament light chain in Scandinavian adults. Scandinavian Journal of Clinical and Laboratory

Investigation. 2020; 80(4): 291-295.

13. Khalil M, Pirpamer L, Hofer E, et.al. Serum neurofilament light levels in normal aging and their association with morphologic brain changes. Nature Communications. 2020; 11:812.

For more information about NfL and how it can benefit your patients,

contact your Labcorp sales representative, or visit Labcorp.com/NfL

©2022 Laboratory Corporation of America® Holdings All rights reserved. DX_SS_L157892-0622-1

AACE Clinical Practice Guideline

on NAFLD in Primary Care and

Endocrinology Clinical Settings

Nonalcoholic fatty liver disease (NAFLD) often occurs in patients with obesity, type 2 diabetes

(T2D), insulin resistance and atherogenic dyslipidemia and is the manifestation of metabolic

disease in the liver. 1 It is estimated that over 80 million people in the United States (US) are living

with NAFLD and that 20% of NAFLD patients in the US have nonalcoholic steatohepatitis (NASH),

the more severe and progressive stage of NAFLD. 2 In patients with T2D, the prevalence of NAFLD

is 50–75% and NASH is 37%. 3,4 It is for this reason that the American Association of Clinical

Endocrinology (AACE) has published new clinical practice guidelines with the purpose of providing

primary care physicians and endocrinologists with practical evidence-based recommendations

for the diagnosis and management of NAFLD. 1

The 2022 AACE guidelines suggest the following for the diagnosis of NAFLD in adult patients: 1

• Consider persons with obesity and/or features of metabolic syndrome, those with prediabetes

or T2D, and those with hepatic steatosis on any imaging study and/or persistently elevated

plasma aminotransferase levels (over 6 months) to be “high risk” and screen for NAFLD and

advanced fibrosis.

• Persons undergoing bariatric surgery should be evaluated for the presence and severity of

NASH, and a liver biopsy should be considered at the time of bariatric surgery. Liver biopsy

should be recommended if presurgical stratification suggests indeterminate or high risk of

liver fibrosis.

• Blood based tests:

• Use liver fibrosis prediction calculations to assess the risk of NAFLD with liver fibrosis.

The preferred noninvasive initial test is the FIB-4.

• Consider persons belonging to the “high risk” group who have an indeterminate or

high FIB-4 score for further workup with an LSM (transient elastography) or ELF test,

as available.

Key Recommendations

Patients with one or more of the

following features should be screened

for NAFLD and advanced fibrosis

• Obesity

• Metabolic syndrome

• Type 2 Diabetes or prediabetes

• Hepatic steatosis on any

imaging study

• Persistently elevated ALT

or AST levels (over 6 months)

Screening Algorithm

• Use FIB-4 to assess the risk

of NAFLD with liver fibrosis

• Consider those with an

indeterminate or high FIB-4

score for further workup

with an LSM (transient

elastography) or ELF test

• Imaging modalities:

• To stage the risk of fibrosis in persons with NAFLD, clinicians should prefer the use of

Vibration controlled transient elastography (VCTE) as best validated to identify advanced

disease and predict liver-related outcomes. Alternative imaging approaches may be

considered, including shear wave elastography (less well validated) and/or magnetic

resonance elastography (most accurate but with a high cost and limited availability;

best if ordered by liver specialist for selected cases).

• In persons with T2D, consider screening for clinically significant fibrosis using the FIB-4, even

if they have normal liver enzyme levels.

• In persons with T1D, consider screening for NAFLD with clinically significant fibrosis using the

FIB-4, only if there are risk factors such as obesity, features of metabolic syndrome, elevated

plasma aminotransferase levels (>30 U/L), or hepatic steatosis on imaging.

• Further risk stratify persons with T2D or T1D with cardiometabolic risk factors and/or elevated

plasma aminotransferase levels (>30 U/L) using the FIB-4, elastography, and/or ELF test.

• Persons with persistently elevated ALT or AST levels and/or with

hepatic steatosis on imaging and indeterminate risk (FIB-4,

1.3-2.67; LSM, 8-12 kPa; or ELF test, 7.7-9.8) or high risk (FIB-4,

>2.67; LSM, >12 kPa; or ELF test, >9.8) based on blood tests and/

or imaging (as described in R2.2.1, R2.2.2, and R2.3) should

be referred to a gastroenterologist or hepatologist for further

assessment, which may include a liver biopsy.

• Refer persons with clinical evidence of advanced liver disease

(ascites, hepatic encephalopathy, esophageal varices, or evidence

of hepatic synthetic dysfunction) to a gastroenterologist/

hepatologist for further care.

For management of NAFLD in adult patients, the AACE guidelines

suggest that clinicians manage persons with NAFLD for comorbidities

such as obesity, metabolic syndrome, diabetes mellitus, dyslipidemia,

hypertension, and cardiovascular disease (CVD) based on the current

standards of care. Physicians should recommend lifestyle changes with

a goal of at least 5%, preferably ≥10%, weight loss. More weight loss

is often associated with greater liver histologic and cardiometabolic

benefit. Dietary modification that reduces macronutrient content and

induces energy deficit and adoption of healthier eating patterns, such

as the Mediterranean diet, is recommended. Furthermore, clinicians

must recommend physical activity that improves body composition

and cardiometabolic health. Physicians must recommend participation

in structured weight loss and exercise programs tailored to the

individual’s lifestyle and personal preferences. While there aren’t

any medications that have been approved by the FDA specifically

for NAFLD/NASH, there are medications that are effective for the

treatment of liver disease as well as the cardiometabolic conditions

associated with NAFLD or NASH. Pioglitazone and GLP-1 receptor

agonists are recommended for persons with T2D and biopsy-proven

NASH. To offer cardiometabolic benefit in persons with T2D and NAFLD,

clinicians must consider treatment with GLP-1 receptor agonists,

pioglitazone, or SGLT2 inhibitors. Due to the lack of evidence of

efficacy, metformin, acarbose, dipeptidyl peptidase IV inhibitors, and

insulin are not recommended for the treatment of NASH but may be

continued as needed for the treatment of hyperglycemia. Clinicians

should recommend the use of obesity pharmacotherapy as adjunctive

therapy to lifestyle modification for individuals with obesity and NAFLD

or NASH with a goal of at least 5%, preferably ≥10 %, weight loss,

when this is not effectively achieved by lifestyle modification alone.

For chronic weight management, clinicians should give preference

to semaglutide 2.4 mg/week (best evidence) or liraglutide 3 mg/day.

Clinicians should consider bariatric surgery as an option to treat NAFLD

and improve cardiometabolic health in persons with NAFLD and a

BMI of ≥35 kg/m2 (≥32.5 kg/m2 in Asian populations), particularly if

T2D is present. For persons with NASH and compensated cirrhosis,

clinicians should exercise caution in recommending bariatric surgery,

which should be highly individualized if prescribed and performed at

experienced centers, however it is not recommended for persons with

decompensated cirrhosis.

Given that NAFLD is a growing public health problem that is

closely linked to the epidemics of obesity and T2D and other

comorbidities and affects many of the patients seen and managed by

endocrinologists and primary health care professionals, it is of vital

importance to increase awareness, diagnosis and treatment for NAFLD.

This is critical for early treatment in order to reduce progression to

cirrhosis and hepatocellular carcinoma. The new AACE guidelines

are a new tool in the armamentarium of patient care.

Labcorp offers the following tests for use in the assessment of NAFLD:

Test Name

FIB-4

Medical decision points:

0.00 – 1.29 Low risk for advanced liver fibrosis

1.30 – 2.67 Indeterminate risk for advanced

liver fibrosis

>2.67 High risk for advanced fibrosis and

for developing of other liver related events

Enhanced Liver Fibrosis (ELF) Test*

Lower risk < 9.80

Mid risk 9.80 – 11.29

Higher risk >11.29

FIB-4 With Reflex to Enhanced Liver Fibrosis

(ELF) Test

>1.29 FIB-4 will reflex to ELF test

Test No.

403604

550659

402175

*The ELF reference ranges in this table were based on the FDA’s intended use of

ELF as a prognostic marker. ELF was cleared in the US to be used in conjunction

with other laboratory findings and clinical assessments in patients with

advanced fibrosis (F3 or F4) due to NASH to assess the likelihood of progression

to cirrhosis and liver-related clinical events. Reference the AACE guidelines

for suggested cut-off points of screening patients for advanced liver fibrosis.

References

1. Cusi K et al. American Association of Clinical Endocrinology Clinical Practice Guideline for the Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Primary Care and Endocrinology

Clinical Settings: Co-Sponsored by the American Association for the Study of Liver Diseases (AASLD). Endocr Pract. 2022 May;28(5):528-562. doi: 10.1016/j.eprac.2022.03.010.

2. American College of Gastroenterology website. Non-alcoholic Fatty Liver Disease (NAFLD). https://gi.org/topics/fatty-liver-disease-nafld/. Accessed October 3, 2019.

3. Lee Y, Cho Y, et al. Nonalcoholic fatty liver disease in diabetes. Part I: epidemiology and diagnosis. Diabetes Metab J 2019;43:31-45. doi: 10.4093/dmj.2019.0011.

4. Budd J, Cusi K. Nonalcoholic fatty liver disease: what does the primary care physician need to know? American Journal of Medicine 2020; 133(5):536-543. doi:10.1016/j.amjmed.2020.01.007

For more information regarding test options, including specimen requirements and CPT codes, please consult the online Test Menu at www.labcorp.com.

Visit the online test menu at Labcorp.com for

additional test options and full test information, including

CPT codes and specimen collection instructions.

©2022 Laboratory Corporation of America® Holdings All rights reserved. DX_WP_L181556-0622-1

LABCORP DIAGNOSTICS

NAFLD and

NASH Testing

Labcorp offers a comprehensive testing portfolio

to help physicians diagnose and manage NAFLD

and NASH patients.

What are NAFLD and NASH?

Non-alcoholic fatty liver disease (NAFLD) is a group of

conditions in which fat builds up in the liver in patients who

drink little to no alcohol. This may range from a non-serious

condition called fatty liver to a more serious condition called

non-alcoholic steatohepatitis — commonly referred to NASH. 1

NASH is a chronic liver disease characterized by liver cell injury

(hepatocellular ballooning) and inflammation as a result of

fatty accumulation (steatosis). This leads to liver scarring and

the development of fibrosis. 2

How are NAFLD and NASH diagnosed?

Liver biopsy is still considered the gold standard for NASH

diagnosis and liver fibrosis staging but the procedure is highly

invasive with risk for complications. 3 These challenges may

result in a delay in diagnosis and treatment. Fortunately, new

research and development efforts have now made noninvasive

markers available for the management of suspected NAFLD

patients. 4-6 These non-invasive blood biomarkers can help

in identifying patients at higher risk of developing NASH and

advanced fibrosis using a rule-out approach.

How do physicians treat and manage NAFLD and

NASH patients?

Behavioral modifications and lifestyle changes are currently

the standards of care for treatment of NASH. Pharmacological

treatment aimed at liver disease, hyperglycemia, dyslipidemia,

and other cardiovascular risk factors may be warranted. 7

Weight loss and medical treatment may reverse NASH. 7 As

more is learned about the underlying pathogenesis of NASH,

new targeted therapeutic approaches are being investigated.

Test Name Test No. Test Description

FIB-4 With Reflex to

NASH FibroSure®

402070

The FIB-4 index can help in evaluation of patients with NAFLD for the presence of liver fibrosis. In this panel,

FIB-4 testing is performed, and if FIB-4 value is greater than 1.29, testing is reflexed to NASH FibroSure®.

NASH FibroSure® 550140

This test is a noninvasive assessment of liver status in patients with NAFLD. Quantitative results of

biochemicals in combination with age, gender, height, and weight are analyzed using a computational

algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis, hepatic steatosis, and NASH.

The absence of steatosis precludes the diagnosis of NASH.

NASHnext 504960

Labcorp’s NASHnext is a non-invasive blood test that reflects both NASH activity and fibrosis in a single

score by combining the results of four individual NASH-associated biomarkers. This test is intended for use

in assigning the risk level of NASH.

References

1. American College of Gastroenterology website. Non-alcoholic Fatty Liver Disease (NAFLD).

https://gi.org/topics/fatty-liver-disease-nafld. Accessed October 3, 2019

2. Non-Alcoholic Steatohepatitis. Understanding NASH, A Major Public Health Issue. The NASH

Education Program.

3. Chalasani N, Younossi Z, Lavine JE, et al. The diagnosis and management of non-alcoholic fatty

liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American

College of Gastroenterology, and the American Gastroenterological Association. Hepatology.

2012;55(6):2005-2023. doi:10.1002/hep.25762

4. Ratziu V, Massard J, Charlotte F, et al. Diagnostic value of biochemical markers (FibroTest-

FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease. BMC

Gastroenterol. 2006 Feb 14; 6:6.

5. Poynard T, Ratziu V, Naveau S, et al. The diagnostic value of biomarkers (SteatoTest) for the

prediction of liver steatosis. Comp Hepatol. 2005 Dec 23; 4:10.

6. Poynard T, Ratziu V, Naveau S, et al. Diagnostic value of two new biomarkers (SteatoTest and NASH

Test) for the prediction of steatosis and nonalcoholic steato-hepatitis (NASH). 41st Annual European

Association for Study of Liver Disease Meeting, April 26-30, 2006, Vienna, Austria. Abstract 86.

7. Bril F, Cusi K. Management of nonalcoholic fatty liver disease in patients with type 2 diabetes: a call

to action. Diabetes Care. 2017;40:419-430. doi: 10.2337/dc16-1787

Get more information about our

NASH and NAFLD testing options.


NAFLD AND NASH

Testing options to help

identify NAFLD and NASH

NAFLD AND NASH

There is a growing,

unmet need in chronic

liver disease.

Non-alcoholic fatty liver disease (NAFLD) is a collective term used to describe a group of

conditions where there is an abnormal accumulation of fat in the liver in those who drink

little to no alcohol. This may range from a non-serious condition called fatty liver to a

potentially serious condition called non-alcoholic steatohepatitis or NASH. 1

NAFLD

NAFLD patients with obesity and features of the metabolic syndrome that include insulin

resistance, type 2 diabetes mellitus, hypertension and dyslipidemia have a higher risk of

progression to NASH. Not all patients have all manifestations of the metabolic syndrome,

however. With the development of NASH, the cardio-metabolic profile worsens, leading to

a higher risk of cardiovascular events and death. 1,2

NASH

NASH is a chronic liver disease characterized by liver cell injury (hepatocellular ballooning)

and inflammation as a result of fatty accumulation (steatosis) seen in at least 5% of

hepatocytes. This leads to liver scarring and the development of fibrosis (scored F0 to

F4). As fibrosis worsens, liver-related morbidity (including cirrhosis and hepatocellular

carcinoma) and mortality increase. 2

80+

million

Number of people in the United

States living with NAFLD 7

NAFLD patients with obesity and features of the metabolic

syndrome that include insulin resistance, type 2 diabetes

mellitus, hypertension and dyslipidemia have a higher risk

of progression to NASH.

Identification of patients at higher risk of NAFLD, NASH

and advanced fibrosis is the first step in optimizing patient

management and therapy.

Symptoms of NASH

The symptoms of NASH may be very non-specific and can

include fatigue, daytime tiredness, or abdominal pain early

in the disease. It is usually discovered incidentally due to

elevated liver enzymes, abnormal imaging studies or surgery.

As cirrhosis advances, NASH-specific symptoms are more

commonly manifested. 2

Typically, most people who develop NASH are between 40

and 50 years old, and have one or more of the following

health concerns: obesity; insulin resistance and type 2

diabetes; high cholesterol and triglycerides; metabolic

syndrome. On the other hand, it is possible for individuals

with none of these risk factors to develop NASH. 3

Prevalence of NAFLD

The prevalence of NAFLD in the United States is reported to

be between 10% and 30% 5 , and the pooled overall global

prevalence of NAFLD diagnosed by imaging was estimated

to be greater than 25%. 6 However, the exact prevalence of

NAFLD and NASH in an adult population remains difficult

to assess due to the lack of a cost-effective and widely

available, minimally-invasive diagnostic test, and to the

absence of specific symptoms before end-stages. There

are many medications in development for the treatment of

NASH; diet, lifestyle modifications and exercise are current

recommendations. 7

NASH Progression

Normal Liver

Inflammation &

ECM degradation

NASH

Hepatocellular

failure

Cirrhosis

F0*

Lipid

accumulation,

hepatocellular &

biliary damage

F1*

steatosis

F2*-F3*

Fibrogenesis

F3*-F4*

Liver Fibrosis

F4*

Complications of

portal hypertension

*NASH Clinical Research Network (CRN) Scoring System

It is estimated that more than 16 million people in the United

States are living with NASH, and the prevalence of NASH will

increase by 63% by the year 2030. 1

At Labcorp, we believe proper testing can help slow the

trends by helping identify those at risk of developing

NAFLD and NASH.

APRI (385375)

The AST to Platelet Ratio Index (APRI) assay is reported to be a

simple, noninvasive, and readily available laboratory test index

that can stratify patients with HCV and NAFLD who are at high or

low risk for significant fibrosis and cirrhosis with high degree of

accuracy. Results from the APRI test include AST, platelet count

and the APRI score.

Enhanced Liver Fibrosis (550659)

The Enhanced Liver Fibrosis (ELF) blood test is a simple,

accurate, non-invasive test that provides a numeric score for use

in patients known to have advanced liver fibrosis. It is indicated as

a prognostic marker in conjunction with other laboratory findings

and clinical assessments in patients with advanced fibrosis (F3 or

F4) due to NASH in order to assess the likelihood of progression to

cirrhosis and liver-related clinical events. 8

FIB-4 (403604)

The FIB-4 index is reported to be a simple, accurate, noninvasive,

and readily available laboratory test index that can help in

evaluation of patients with HCV and NAFLD for the presence of

liver fibrosis, and the indication for liver biopsy, and other liverrelated

complications. Results from the FIB-4 test include ALT, AST,

platelet count and the FIB-4 score.

FIB-4 With Reflex to NASH FibroSure® (402070)

The FIB-4 index is reported to be a simple, accurate, noninvasive,

and readily available laboratory test index that can help in

evaluation of patients with HCV and Non-Alcoholic Fatty Liver

Disease (NAFLD) for the presence of liver fibrosis indication for

liver biopsy, and other liver-related complications.

Liver Fibrosis Risk Profile With Hepatic Function Panel,

Complete Blood Count (CBC) With Differential, FIB-4, and

APRI (402145)

This profile is intended for use in screening patients suspected

to be at risk for liver fibrosis. AST to Platelet Ratio Index (APRI)

is reported to be a simple, noninvasive, and readily available

laboratory test index that can stratify patients with HCV and Non-

Alcoholic Fatty Liver Disease (NAFLD) who are at high or low risk

for significant fibrosis and cirrhosis with high degree of accuracy.

FIB-4 index is reported to be a simple, accurate, noninvasive, and

readily available laboratory test index that can help in evaluation

of patients with HCV and Non-Alcoholic Fatty Liver Disease

(NAFLD) for the presence of liver fibrosis indication for liver biopsy,

and other liver-related complications.

NAFLD Cascade (402205)

The NAFLD Advanced Rule-Out Cascade is intended for use

in patients with NAFLD and suspected NASH with advanced

fibrosis that include subjects with no alcohol related disorders

and any of the following: elevated liver function tests, obesity,

type 2 diabetes, metabolic syndrome, imaging evidence of fat

accumulation, dyslipidemia, polycystic ovary syndrome. These

patients may be at high risk for progression to advanced liver

fibrosis that can cause a fast progression to end-stage liver

disease, hepatocellular carcinoma, and liver transplantation. Noninvasive

blood biomarkers can help identify those patients using

rule-out approach. Liver biopsy is still required to definitively

diagnose patients with NASH and NASH fibrosis.

NASHnext (504960)

Utilizing NIS4 technology, NASHnext is a blood-based diagnostic

test that quantitatively measures four independent biomarkers

to produce a score that identifies, among patients with metabolic

factors, those with at-risk NASH, who are at higher risk of disease

progression.

NASH FibroSure (550140)

This noninvasive assessment of liver status in patients with NAFLD

provides quantitative results of 10 biochemicals in combination

with age, gender, height, and weight. These factors are analyzed

using a computational algorithm to provide a quantitative

surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic

steatosis (0.0-1.0, S0-S3), and NASH (0.0-0.75, N0-N2). The absence

of steatosis (S<0.38) precludes the diagnosis of NASH.

NASH FibroSure Plus® (550960)

NASH FibroSure Plus® offers a more streamlined testing process

than NASH FibroSure: BMI is no longer included in the calculation,

eliminating one step for providers.

NAFLD and NASH Related Tests

Test Name

Test No.

Test Name

Test No.

NASH

AST and Platelets with APRI 385375

Enhanced Liver Fibrosis (ELF) 550659

FIB-4 403604

FIB-4 with Reflex to NASH FibroSure® 402070

Liver Fibrosis Risk Profile with Hepatic Function Panel,

Complete Blood Count (CBC) With Differential, FIB-4, and

APRI

402145

NASHnext 504960

NASH FibroSure® 550140

NASH FibroSure Plus® 550960

Non-Alcoholic Fatty Liver Disease Advanced Fibrosis

Rule-Out Cascade

Risk of Cardiovascular Disease and Type 2 Diabetes

402205

Glucose, Plasma 001818

Hemoglobin (Hb) A1c 001453

Insulin 004333

Lipid Panel Plus ApoB 123544

Lipid Panel Plus Diabetes Risk Index 123525

Lipid Panel Plus Inflammation 123510

Lipid Panel Plus Inflammation and Diabetes Risk Index 123559

Lipid Panel Plus Inflammation, Diabetes Risk Index and

Apo B

NMR LipoProfile® With Insulin Resistance Markers

Without Lipids

NMR LipoProfile® With Lipids and Insulin Resistance

Markers

Liver Related Markers

123567

123497

123638

α2-Macroglobulin, Quantitative 122135

Alanine Aminotransferase (ALT/SGPT) 001545

Albumin 001081

Alkaline Phosphatase 001107

Aspartate Aminotransferase (AST/SGOT) 001123

Bile Acids 010330

Lactic Acid Dehydrogenase (LD) 001115

Protein, Total 001073

ASH

ASH FibroSure® 550180

Ethyl Glucuronide/Ethyl Sulfate (EtG/EtS), Screen and

Confirmation, Urine

Hepatitis

737610

Acute Viral Hepatitis (HAV, HBV, HCV) 144000

Hepatitis A Virus (HAV) Antibody, Total 006726

Hepatitis A Antibody, IgM 006734

Hepatitis B Virus (HBV) Screening and Diagnosis 144473

Hepatitis B Core Antibody, Total 006718

Hepatitis B Surface Antibody, Qualitative 006395

Hepatitis B Surface Antigen (HBsAg) Screen, Qualitative 006510

Hepatitis B Surface Antigen, Quantitative, Monitor 007130

Hepatitis B Virus (HBV) Genotype 551710

Hepatitis B Virus (HBV) Genotyping Plus Drug Resistance 551750

Hepatitis B Virus (HBV), Quantitative, DNA Real-time PCR,

(Nongraphical)

Hepatitis C Virus (HCV) Antibody With Reflex to

Quantitative Real-time PCR

551610

144050

Hepatitis C Virus (HCV) FibroSure® 550123

Hepatitis C Virus (HCV) GenoSure® NS3 / 4A 550540

Hepatitis C Virus (HCV) Genotype 3 NS5A Drug Resistance

Assay

550603

Hepatitis C Virus (HCV) Genotyping, Nonreflex 550475

Hepatitis C Virus (HCV) NS5A Drug Resistance Assay 550325

Hepatitis C Virus (HCV) NS5B Drug Resistance Assay 550505

Hepatitis C Virus (HCV), Quantitative, Real-time PCR

(Graphical)

Hepatitis C Virus (HCV), Quantitative, Real-time PCR

(Nongraphical)

Hepatitis C Virus (HCV), Quantitative, RNA PCR (Graphical)

With Reflex to Genotyping

Hepatitis C Virus (HCV), Quantitative, RNA PCR

(Nongraphical) With Reflex to Genotyping

Other

550070

550080

550100

550090

α-Fetoprotein (AFP), Tumor Marker 002253

α-Fetoprotein (AFP), Tumor Marker (Serial Monitor) 480012

α-Fetoprotein (AFP) With AFP-L3%, serum 141300

α1-Antitrypsin, Serum (preferred) or plasma 001982

α1-Antitrypsin Deficiency, DNA Analysis 511881

α1-Antitrypsin Phenotyping, Serum 095653

γ-Glutamyl Transferase (GGT) 001958

Actin (Smooth Muscle) Antibody (ASMA) 006643

Ammonia, Plasma 007054

Bilirubin, Total and Direct 001214

Ceruloplasmin 001560

Copper, Serum or Plasma 001586

Copper, Urine 003343

Hereditary Hemochromatosis, DNA Analysis 511345

Liver-Kidney Microsomal (LKM) Antibodies 163980

Mitochondrial (M2) Antibody 006650

Soluble Liver Antigen (SLA) IgG Antibody 007441

Thyroid Peroxidase (TPO) Antibodies 006668

Power of the Combined

Labcorp and Labcorp Drug Development working to

bring NASH technologies to the forefront

Superior testing options with NASHnext, NASH FibroSure®,

NAFLD cascade, and more through Labcorp

• 15 NAFLD/NASH studies in 5 years, with 4 global phase 3

studies in progress at Labcorp Drug Development

• 4,000+ biopsy-confirmed patients recruited by Labcorp

Drug Development, plus metrics on 700+ sites across 28

countries

• 31 NAFLD/NASH and NASH cirrhosis studies currently

being conducted in our labs as of 2019

Drug development leadership & medical testing expertise

makes Labcorp Drug Development & Labcorp your choice

for NASH collaboration

References

1. American College of Gastroenterology website. Non-alcoholic Fatty Liver Disease (NAFLD). https://gi.org/topics/fattyliver-disease-nafld/.

Accessed October 3, 2019.

2. Non-Alcoholic Steatohepatitis. Understanding NASH, A Major Public Health Issue. The NASH Education Program.

3. National Institute of Diabetes and Digestive and Kidney Diseases website. Symptoms & Causes for NAFLD & NASH.

https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/symptoms-causes. Accessed March 15, 2021.

4. Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non‐alcoholic fatty

liver disease and non‐alcoholic steatohepatitis in adults. Aliment Pharmacol Ther 2011;34:274‐285.

5. Younossi ZM, Koenig AB, Abdelatif D, et al. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic

assessment of prevalence, incidence and outcomes. Hepatology 2016; 64(1):73-84

6. National Institute of Diabetes and Digestive and Kidney Diseases website. Treatment for NAFLD & NASH. https://www.

niddk.nih.gov/health-information/liver-disease/nafld-nash/treatment. Accessed October 3, 2019.

7. Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease

demonstrates an exponential increase in burden of disease. Hepatology. 2018 Jan;67(1):123-133.

8. ADVIA Centaur® Enhanced Liver Fibrosis (ELF) [package insert]. Tarrytown, NY. Siemens Healthcare Diagnostics Inc.

Rev. 01, 2021-08.

For more information about NASH-NAFLD

and how it can benefit your patients,

visit Labcorp.com/NASH


RHEUMATOLOGY

Optimizing Biologic

Therapy in Rheumatic

Disease

DoseASSURE, Labcorp’s portfolio of biologics monitoring assays, may help

physicians optimize biological therapy using a personalized, patient-specific approach by:

• Aiding in titrating doses and adjusting frequency to maximize effectiveness 1,2

• Identifying lack of response due to non-compliance or under-treatment 3

• Assisting in preventing and managing loss of response due to immunogenicity 1,4

• Predicting which patients are likely to retain long-term response 5

• Minimizing cost to patient by avoiding unhelpful dose escalation 6

• Avoiding overtreatment in low disease activity cases where tapering down is desirable 7

• Elucidating poor response as due to undertreatment (pharmacokinetic), mechanistic mismatch (pharmacodynamic)

or development of anti-drug antibodies (immunogenic)

Biologic Drug Name Primary Target* Clinical Indications* Test Name Test No.

Adalimumab (Humira®) TNF CD, UC, RA Adalimumab and Anti-Adalimumab Antibody, DoseASSURE ADL 503890

Certolizumab (Cimzia®) TNF CD, RA, PA, PP Certolizumab and Anti-Certolizumab Antibody, DoseASSURE CTZ 504627

Etanercept (Enbrel®) TNF RA, JIA, PA, PP, AS Etanercept and Anti-Etanercept Antibody, DoseASSURE ETN 504245

Golimumab (Simponi®) TNF UC, RA Golimumab and Anti-Golimumab Antibody, DoseASSURE GOL 504563

Infliximab (Remicade®;

Avsola, Renflexis®)

TNF CD, UC ** Infliximab and Anti-Infliximab Antibody, DoseASSURE IFX 503870

Rituximab (Rituxan®) CD20 RA, NHL, CLL Rituximab and Anti-Rituximab Antibody, DoseASSURE RTX 504355

Ustekinumab (Stelara®) IL23, IL12 CD, PA, PP Ustekinumab and Anti-Ustekinumab Antibody, DoseASSURE UST 504594

* Partial listing of FDA-approved indications. TNF: tumor necrosis factor, IL: interluken, CD: Crohn’s Disease, UC: Ulcerative Colitis, RA: Rheumatoid Arthritis, PA: Psoriatic Arthritis, PP: Plaque Psoriasis, JIA:

Juvenile Idiopathic Arthritis, AS: Ankylosing Spondylitis, NHL: Non-Hodgkin’s Lymphoma, CLL: Chronic Lymphocytic Leukemia

** Published validation study, Marini JC, et al. Comparisons of Serum Infliximab and Antibodies-to-Infliximab Tests Used in Inflammatory Bowel Disease Clinical Trials of Remicade® AAPS Journal 2016. DOI:

10.1208/s12248-016-9981-3

DoseASSURE test portfolio provides tests for both drug concentration (TDM)

& anti-drug antibody (immunogenicity)

Therapeutic Drug Monitoring (TDM)

• Biologics have variable pharmacokinetics. 2,4

• Dosing by weight and empiric dose adjustment may be inefficient

and suboptimal. 2,6

• Clinical efficacy in RA and/or psoriasis has been shown to

correspond with serum concentrations of infliximab, adalimumab,

etanercept, golimumab, rituximab, and ustekinumab. 4,8-14

• TDM for biologics is a valuable tool to evaluate doses and to tailor

dose adjustments to your individual patient. 1-4,6

• TDM can help differentiate non-compliance and under-treatment

from other causes of lack of response. 3

• Personalized treatment using TDM has been shown to improve

both clinical and cost-effectiveness in RA. 6

Immunogenicity Testing (Anti-drug Antibody level)

• All biologics have the potential to induce an antibody-mediated

immune response. 1,15

• As many as one third of RA patients on biological therapy may

develop anti-drug antibodies. 15,16

• Anti-drug antibodies may appear as early as 2 weeks or as late as

3 years after the first infusion. 17

• Co-therapy with methotrexate, sufficient drug levels, and

maintenance dosing (vs. episodic or on-demand use) reduce the

risk of anti-drug antibody formation. 15-20

• Anti-drug antibodies can adversely affect the amount of drug in

the body. 1,15,16,19 Therefore, concomitant measurement of anti-drug

antibodies is an important adjunct to TDM for biologics.

Interpreting Drug Concentrations

• Higher drug trough levels have been correlated with clinical

improvement as well as to higher rates of response and

remission in rheumatic diseases. 4,8-13

• A consensus has yet to be reached about target ranges and

maximally effective concentrations. 1

Optimal drug concentration depends on the disease and the

desired therapeutic endpoint.

Interpreting Anti-Drug Antibody Levels

• Anti-drug antibodies may impact pharmacokinetics, efficacy, and

cost-effectiveness.

• Low titer antibodies may have little or no effect on drug levels or

clinical outcome. In fact, they may be transient and disappear over

time, or they may progress to increasing titers. 1,16,18,21

• In contrast, high titers of antibodies are likely to be more

consequential, leading to loss of drug efficacy by preventing drug

binding to TNF and/or increasing drug clearance. 1,16,19

Anti-drug antibody positivity should be interpreted in the context of

the concomitant free drug level.

Drug Normal half-life Proposed Target Trough Concentrations§ Other clinical data on Trough Concentrations

Adalimumab

Certolizumab

Etanercept

Approx. 2 weeks

Approx. 2 weeks

3 – 5.5 days

5 - 8 μg/mL in RA9; 5 - 8 μg/mL in PA22; 3.5 – 7.0 μ/

mL in psoriasis 23

>23 μg/mL corresponded to better EULAR response

rates. 24

A definitive target range has yet to be determined.

In RA, good responders had higher levels (median 3.8 μg/mL 2.5 –

> 3.1 μg/mL (at 3 months predicted response at 6 5.2) compared to non-responders (2.8 μg/mL 1.3 -3.9). 10 In AS, clinical

months in RA.) 25 responders (ASDAS) had higher median levels (median 3.8 μg/mL,

2.5 – 5.2) than non-responders (2.3 μg/mL, 1.2 – 3.4). 5

Golimumab Approx. 2 weeks No consensus on clinical recommendation for RA

Infliximab 7.7 to 9.5 days < 2 μg/mL: low and ≥ 8 μg/mL: high in RA2

Rituximab 18 days (5.2-77.5 days) No consensus on clinical recommendation for RA

Ustekinumab Approx. 3 weeks A definitive target range has yet to be determined

§Note: These targets ranges were those used in landmark studies and do not necessarily translate into general recommendations for individual patients.

In RA, higher levels (median 3.4 μg/mL) were associated with a

greater rate of clinical response (ACR20). 11

In RA, responders had higher levels (median 3.6 μg/mL, 1.4 – 8.2)

than non-responders (0.5 μg/mL, 0.2 – 2.2). 8

In psoriasis, PASI 50 responders had higher trough concentrations

than non-responders. 14

When & where to collect blood on my patients?

• The timing of sample collection is important because the drug concentration will change during the dosing interval.

• The Trough Concentration (TC) is measured at the least variable time in the dosing interval, just before the next dose (same day to within

<7 days depending on the drug’s normal half-life).

• During induction and maintenance phases, trough collections are usually recommended because target ranges are defined using TC.

• Blood can be drawn at any of Labcorp’s nearly 2000 patient service centers located nationwide.

References

1. Vincent FB, et al. Antidrug antibodies to tumour necrosis factor (TNF)-specific neutralizing agents in

chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis 2013;72:165-178.

2. Mulleman D, et al. Infliximab concentration monitoring improves the control of disease activity in

rheumatoid arthritis. Arthritis Res Therapy 2009;11(6):R178.

3. Chen DY, et al. Significant associations of antidrug antibody levels with serum drug trough levels and

therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis. Ann Rheum Dis

2015;74:e16

4. Mulleman D, et al. Should anti-TNF-a drug levels and/or anti-drug antibodies be assayed in patients

treated for rheumatoid arthritis? Joint Bone Spine 2012;79:109-112.

5. Kneepkens EL, et al. Lower etanercept levels are associated with high disease activity in ankylosing

spondylitis patients at 24 weeks of follow-up. Ann Rheum Dis 2015;74:1825-1829.

6. Krieckaert CLM, et al. Personalised treatment using serum drug levels of adalimumab in patients with

rheumatoid arthritis: an evaluation of costs and effects. Ann Rheum Dis 2015;74:361-368.

7. denBroeder AA, et al. Dose de-escalation strategies and role of therapeutic drug monitoring of

biologics in RA. Rheumatol 2010;49:1801-1803.

8. Wolbink GJ, et al. Relationship between serum trough infliximab levels, pretreatment C reactive

protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis. Ann

Rheum Dis 2005;64:704-707.

9. Pouw MF, et al. Key finding towards optimizing adalimumab treatment:the concentration-effect curve.

Ann Rheum Dis 2015;74:513-518.

10. Jamnitski A, et al. Patients non-responding to etanercept obtain lower etanercept concentrations

compared with responding patients. Ann Rheum Dis 2012;71:88-91.

11. Kay J, et al. Golimumab in Patients with Active Rheumatoid Arthritis Despite Treatment with

Methotrexate. Arthritis Rheum 2008;58(4):964-975.

12. Diana M, et al. Correlation between serum rituximab level and clinical response in rheumatoid

arthritis patients treated with a B cell depletion therapy. Ann Rheum Dis 2014;73:390

13. Reddy V, et al. Serum rituximab levels and efficiency of B cell depletion: differences between patients with

rheumatoid arthritis and systemic lupus erythematosis. Rheumatol 2013;52:951-952.

14. Chiu H-Y, Chu TW, Cheng Y-P, Tsai T-F. The association between clinical response to ustekinumab and

immunogenicity to ustekinumab and prior adalimumab. PLoS One. 2015;10(11):e0142930. doi: 10.1371/

journal.pone.0142930.

15. Schaeverbeke T, et al. Immunogenicity of biologic agents in rheumatoid arthritis patients: lessons for

clinical practice. Rheumatol 2016;55:210-220.

16. Pascual-Salcedo D, Et al. Influence of immunogenicity on the efficacy of long-term treatment with

infliximab in rheumatoid arthritis. Rheumatol 2011;50:1445-1452.

17. Thomas SS, et al. Comparative Immunogenicity of TNF Inhibitors: Impact on Clinical Efficacy and

Tolerability in the Management of Autoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs.

2015;29:241-258.

18. Garces S, et al. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a

systematic review of the literature with a meta-analysis. Ann Rheum Dis 2013;72:1947-1955.

19. Bartelds GM, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and

serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis 2007;66:921-926.

20. Krieckaert CL, et al. Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis

patients in a dose dependent manner. Ann Rheum Dis 2012;71(11):1914-1915.

21. Dore RK, et al. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in

patients with rheumatoid arthritis. Clin Experimental Rheumatol 2007;25:40-46.

22. Vogelzang E, et al. A concentration-effect curve of adalimumab in patients with psoriatic arthritis. Ann

Rheum Dis 2014;74:88-89.

23. Menting SP, et al. Developing a Therapeutic Range of Adalimumab Serum Concentrations in Management

of Psoriasis. JAMA Derm 2015;151(6):616-622.

24. Jani M et al. High frequency of antidrug antibodies and association of random drug levels with efficacy in

certolizumab pegol-treated patients with rheumatoid arthritis: results from the BRAGGSS cohort Ann Rheum

Dis 2017;76:208-213.ext.

25. Daien CI, et al. Etanercept Concentration in Patients with Rheumatoid Arthritis and Its Potential Influence

on Treatment Decisions: A Pilot Study. J Rheumatol 2012;39:1533-1538.

For more information,

visit labcorp.com. or call 800-444-9111.


®

ThyGeNEXT

THYROID ONCOGENE PANEL

+

®

ThyraMIRv2

THYROID miRNA RISK CLASSIFIER

Comparative Overview of Clinical Validation Studies

Test Characteristics

ThyGeNEXT ® +

ThyraMIR ® v2 1 Afirma GSC ®2

Methodology

Published Performance

(Bethesda III and IV Nodules)

• DNA Sequencing

• RNA Sequencing

• microRNA Classification

Sensitivity 98%*

Negative/Moderate Thresholds

Specificity 98%*

Positive Threshold

NPV 99%*

Negative Samples

PPV 96%*

Positive Samples

• RNA Sequencing

91%

68%

96%

47%

Cancer Prevalence 30%* 24%

Comparative Performance

(30% Cancer Prevalence)

Test Result Categories

NPV 99%*

Negative Samples

PPV 96%*

Positive Samples

• Negative

• Moderate

• Positive

95% 3

55% 3

• Negative

• Suspicious

Sample Type Accepted

• 1 Dedicated Pass

—or—

• Diagnostic Cytology Slide

(at least 80 follicular cells)

• Cell Blocks

• 2 Dedicated Passes

Detects BRAF V600E, RET/PTC

Test Can Detect MTC

Detects TERT Promoter Mutations

Detects ALK Mutations †

Fixed Cytology Smears Acceptable for Testing

High Quality Digital Slide Image Captured and Stored

Sample Can Be Stored and Shipped Without Refrigeration

Compact Shipping Kit to Minimize Office Storage Needs

Patient management decisions are based on the independent medical judgment of the physician and molecular test results should be taken into

consideration in conjunction with all relevant imaging, clinical findings, patient and family history, as well as patient preference.

*3-Category performance aligned to clinical decision-making in Bethesda III and IV nodules and based upon positive and negative thresholds. Binary test

performance metrics are 99% NPV and 75% PPV. 1,4

†

The Afirma Xpression Atlas can detect ALK fusions.

Afirma ® is a trademark of Veracyte, Inc.

References: 1. Finkelstein SD, Sistrunk JW, Malchoff CD, et al. A retrospective evaluation of the diagnostic performance of an interdependent pairwise

microRNA expression analysis with a mutation panel in indeterminate thyroid nodules [published online ahead of print, August 9, 2022]. Thyroid. doi:10.1089/

thy.2022.0124. 2. Patel KN, et al. JAMA Surg. 2018;153(9):817-824. 3. Data on File. 4. Lupo MA, et al. Diagn Cytopathol. 2020;1-11. https://doi.org/10.1002/

dc.24564.

©2022 Interpace Biosciences ® . All Rights Reserved.

Interpace Diagnostics ® , LLC is a subsidiary of Interpace Biosciences, Inc.

THY-0135-01-0922

THYROID MOLECULAR TESTING

ThyGeNEXT ® and

ThyGeNEXT with

reflex to ThyraMIR ® v2

Overcome Diagnostic Uncertainty

• ThyGeNEXT® includes the primary mutations associated with

thyroid malignancy including but not limited to BRAF, RET, TERT,

ALK, RET/PTC, RAS, PTEN, PAX8/PPARy, and PIK3CA. 1

• ThyraMIR ® v2 includes 11 microRNA markers and is performed

if ThyGeNEXT is negative or not fully indicative of malignancy. 2

• Learn more at: www.thyroiddx.com/pairwise or,

scan the QR code with your mobile device.

Product Summary

• Only testing platform that utilizes both mutational

and microRNA markers

• HIGHEST NPV and PPV commercially available 2–4

• Diagnostic and prognostic Markers that Matter® aid patient

management decisions—including treatment choice

aligned to FDA-approved targeted therapies 5–10

• Specimens can be provided as fresh FNA specimens

collected in provided buffer

• Compact shipping kit designed to take up minimal

office storage space

• No special shipping or refrigeration is needed

• Covered by Medicare and most managed care plans

*3-Category performance aligned to clinical decision-making in Bethesda III and IV nodules and based upon positive and negative thresholds.

Moderate‐risk cohort reduced to 13% of samples tested. Binary test performance metrics are 99% NPV and 75% PPV. 2

Test Name Test No. CPT Code

ThyGeNEXT 824813 0245U

ThyGeNEXT with reflex to ThyraMIRv2 824826 0245U with reflex to 0018U

ThyGeNEXT and ThyraMIRv2 are registered trademarks of Interpace Biosciences ® .

ThyGeNEXT and ThyraMIRv2 are performed by Interpace Diagnostics ® as a send-out from Labcorp.

References

1. Lupo MA, et al. Diagn Cytopathol. 2020;48(12):1254‐1264. doi:10.1002/dc.24564.

2. Finkelstein SD, et al. A retrospective evaluation of the diagnostic performance of an interdependent pairwise microRNA expression analysis

with a mutation panel in indeterminate thyroid nodules [published online ahead of print, August 9, 2022]. Thyroid. doi:10.1089/thy.2022.0124.

3. Steward DL, et al. JAMA Oncol. 2019;5(2):204‐212.

4. Patel KN, et al. JAMA Surg. 2018;153(9):817‐824.

5. Liu X, et al. Endocr Relat Cancer. 2013;20(4):603‐610. doi:10.1530/ERC‐13‐0210.

6. Melo M, et al. J Clin Endocrinol Metab. 2014;99(5):E754‐E765. doi:10.1210/jc.2013‐3734.

7. Yang X, et al. J Nucl Med. 2017;58(2):258‐265. doi:10.2967/jnumed.116.180240.

8. Haugen BR, et al. Thyroid. 2016;26(1):1‐133. doi:10.1089/thy.2015.0020.

9. Drugs Approved for Solid Tumors Anywhere in the Body. National Cancer Institute. Accessed May 20, 2022. www. cancer.gov/about‐cancer/

treatment/drugs/solid‐tumors.

10. Drugs Approved for Thyroid Cancer. National Cancer Institute. Accessed May 20, 2022. www.cancer.gov/about‐cancer/ treatment/drugs/thyroid.

96%

PPV* 2

In Positive

Samples

99%

NPV* 2

In Negative

Samples

Visit labcorp.com or contact your local

representative for more information.

©2022 Laboratory Corporation of America® Holdings All rights reserved. DX_SS_L24738-0922-2

Vectra Enhanced Care

Utilizing a molecular assessment along with a physician assessment

and a patient assessment provides the most comprehensive

view of a patient’s rheumatoid arthritis inflammation.

1

Rheumatoid Arthritis (RA) is a Heterogeneous

and Systemic Disease That is Challenging to Manage

$22B

$22B annual spend on

treatment in the U.S. 1

60%

60% of inadequately treated

RA patients become disabled

within 10 years 2

36-

84%

Historically, 36-84% of RA

patients had reduced work

capacity and eventually stopped

working after their diagnosis 3

2

Improving Disease Control with

Treat-to-Target Strategies

Discordance

The rheumatologist should involve the patient

in setting the treatment target and the

strategy to reach this target 4

Achieving a state of disease

remission in rheumatoid

arthritis is considered a primary

treatment goal 4

Until the desired treatment target is reached, drug therapy

should be adjusted at least every three to six months.

The desired treatment target should be maintained

throughout the remaining course of the disease 4

Early detection, disease activity

monitoring and treatment have:

• Improved outcomes

• Reduced disease severity, co-morbidity,

disability and mortality

• Made remission possible

3

Provider and Patient Assessments of Disease, Pain,

Functionality and Satisfaction Can Be Discordant

UP TO

40%

Patient-Provider discordance in RA disease

assessment happens up to 40% of the time 6

• 30% of RA patients rate their disease activity

higher than their providers 5

• 3-10% of RA patients rate their disease activity

lower than their providers 5

The patient experience of RA is difficult

to objectively see and measure due to: 6

• Discordance in

• Patient assessments

• Physician and laboratory assessments

• Co-morbidities

63% of patients did not set

treatment goals with their provider 7

4

Laboratory Results Are Valuable But Often

Discordant with Clinical Assessments

ESR and CRP Were Both Low in ~50% of Patients

with High Clinical Disease Activity (CDAI >22) 8

Acute phase reactant levels by CDAI (percentage of patients)

LOW MODERATE HIGH

10% 16%

23%

27%

26%

27%

67%

57%

46%

>2.8 to ≤10 (N=1,988)

>10 to ≤22 (N=1,331) >22 (N=909)

Clinical Disease Activity by CDAI

CRP AND ESR Elevated

CRP OR ESR Elevated

CDAI, clinical disease activity index. Low CRP, ≤0.8 mg/dL. Low ESR, ≤28 mm/hr.

Study from the CORRONA registry: data from 9,135 patients with active RA (CDAI >2.8)

Both CRP AND ESR Low

5

Laboratory Results Can Be Discordant with

Clinical Disease Activity

~70% of RA patients have low CRP or ESR,

58% have low CRP & ESR, despite elevated CDAI 9

Data from 9,135 patients with active RA (CDAI >2.8)

Low CRP

≤0.8 mg/dL

Low ESR

≤28 mm/hr

71%

N=6,507

70%

N=6,416

Low CRP, Low ESR

≤0.8 mg/dL, ≤28 mm/hr

58%

N=5,295

CDAI = Clinical Disease Activity Index

Study from the CORRONA registry: data from 9,135 patients with active RA (CDAI >2.8)

6

Clinical Remission (DAS28 <2.6) Does Not Eliminate the

Risk for Radiographic Progression (RP) 9

Structural damage can continue even

when symptoms appear under control

N=102

19% of patients in

clinically defined remission

had progression of

radiographic joint damage

over 1-year

Vectra ®

NO SINGLE BIOMARKER is able to

predict radiographic progression better than Vectra

Vectra provides an objective measure of RA

inflammation and can be used to complement

other disease activity measures.

7

Vectra Provides a Personalized Score 10

12

Biomarkers

Age

Gender

Adiposity

Key Factors in Creating a

Personalized Vectra

• Vectra measures the concentrations

of 12 serum proteins

• An algorithm is applied to these

concentrations to provide a quantitative

disease activity score

• The Vectra score also accounts for age,

gender and adiposity

Vectra simultaneously measures 12 proteins that

are involved in multiple key pathways of RA

12 Biomarkers Assess Systemic Disease Activity in RA

Adhesion

Molecules

Growth

Factors

Cytokines/

Receptors

Matrix

Metalloproteinases

Skeletal-Related

Proteins

Hormones

Acute-Phase

Proteins

VCAM-1

EGF

VEGF-A

IL-6

TNF-RI

MMP-1

MMP-3

YKL-40

Leptin

Resistin

SAA

CRP

Cellular Influx & Tissue

Growth

Inflammation

& Destruction

Cartilage Degradation

& Joint Damage

Stromal Activity

& Regulation

Systemic Inflammatory

Response

Vectra is an objective, more comprehensive measure

of RA disease activity than any single biomarker

8

*Interpretation of individual biomarker results has not been validated.

Vectra is an unsurpassed predictor

of radiographic progression

18

16

17

14

P=0.000042

Predictive Power

12

10

8

6

4

2

0

3.9

P=0.049

4.3 4.5

P=0.040

P=0.032

6.4

P=0.0093

12.2

P=0.00036

CDAI SDAI DAS28-CRP CRP Vectra Adjusted

Vectra*

Radiographic

Progression

Vectra’s Ability to Predict Radiographic Progression May Help

Guide Personalized Medical Management Decisions

40%

In the largest analysis to date, Vectra was

validated as a superior prognostic for

radiographic progression when compared

with conventional measures.

Progression risk increased continuously

with the Vectra Score, exceeding 40% for

the highest scores. 11

*Adjusted for age, gender and adiposity

9

Four Cohorts with Requisite Data Were Identified and

Combined (N=953) 11

Leiden

registry

OPERA

study

SWEFOT

study

BRASS

registry

N=163 N=154 N=235 N=401

• The four cohorts combined (N=953) included patients receiving biologic and

non-biologic DMARDS

• In continuous and binary analyses, the Vectra® Score was the most significant predictor of

radiographic progression over one year compared to eight other variables

• The analysis demonstrated that RP aligned more closely with the adjusted Vectra Score than

conventional measures, even when they were discordant

• A risk curve was created, showing RP increases continuously with an increasing Vectra Score,

with RP risk of >40% among the highest adjusted Vectra Scores

The frequency of radiographic progression agreed

more with the adjusted Vectra Score than

with DAS28-CRP, CRP, SJC or CDAI, both overall

and when they were discordant.

10

Regardless of the Level of Disease Activity or Conventional

Measure Used, Those with a High Vectra Score Were at a

Higher Risk for Rapid Radiographic Progression 11 7-47%

Radiographic progression (RP; ΔTSS >5) by category of adjusted Vectra Score cross-classified

with conventional disease activity measures

LOW (<30) MODERATE (30-44) HIGH (>44)

Adjusted Vectra Category

Patients with RP (%)

15

10

5

0

16.8%

16.1%

15.8%

14.3%

(74/441)

(5/31)

(86/544)

(6/42)

13.2%

(12/91)

15

11.1%

9.0%

(1/9)

(6/67)

10

3.0%

4.2% 4.8%

3.1%

2.8%

1.9%

5

(2/48) (4/84)

5.5%

(2/67)

(1/33)

(3/107)

(7/127)

(1/53) 0%

0% 0%

0%

(0/29)

(0/56) (0/35)

(0/12)

0

≤2.67 2.67 to 4.09 >4.09 ≤1

1 to 3

>3

DAS28-CRP

C-reactive Protein (mg/dL)



15

10

5

0

16.2%

(6/37)

15.2%

(44/290)

16.3%

(42/257)

7.7%

(5/65) 10

5.6%

6.4%

(3/47)

5.6%

3.7%

(4/71)

4.7%

(2/36)

3.3%

2.5%

(1/27)

5

(2/43)

(1/40)

1.8%

(1/30) 2.2%

0% (2/114)

(2/89)

0%

0%

(0/52)

(0/41)

(0/22)

0

0 1 to 9 ≥10 ≤10

>10 to 22

>22

Swollen Joint Count

CDAI


15

12.5%

(16/128)

15.5%

(51/330)

A High Vectra Score Correlates with a Risk of Higher Future Irreversible Joint Damage 11

The risk for radiographic progression over one year increases continuously with an increasing Vectra Score.

Change in 8

1-Year Risk of Radiographic

Progression

Risk of ΔTSS >5 over 1 year

50%

40%

30%

20%

10%

0%

1

20 40 60 80 100

Vectra Score

VECTRA

SCORE

HIGH

(45-100)

MODERATE

(30-44)

LOW

(1-29)

RISK OF

RAPID RP

4 -6%

1- 3%

11

Importance of Knowing Minimally Important

Difference for Vectra

• Minimally Important Difference (MID) in patients with moderate

or high Vectra Scores is 8. A change of ≥8 in the Vectra Score is

meaningful 12

• When a patient is changing or starting a new therapy

• A decrease of the Vectra Score of ≥8 units may be indicative of response

to treatment for those patients in moderate or high disease activity

• An increase in the Vectra Score of ≥8 units for those patients in the

moderate or high category may indicate an increase in disease activity

and may require adjustment to current treatment

• Changes in Vectra Scores of 8 or more can help guide medical

management decisions by representing a meaningful change

in RA inflammation

12

*The meaningful change is only for Vectra Scores in the moderate or high disease activity range.

PATIENT CASE STUDY

CASE

INSIGHT

PATIENT INFORMATION

LABS & SEROLOGY

Age: 50

Gender: F

CRP: 1.42 mg/L

ESR: 30 mm/hr

DISEASE ACTIVITY MEASUREMENTS

RF: N/A

SJC28: 5 TJC28: 3

MD Global: --

Patient Global: --

Pain VAS: 1 (Low)

MEDICATIONS

Methotrexate, 15 months

Adalimumab, 12 months

RAPID3: 1.3 (Low)

13

PATIENT SCENARIO 1

Vectra ® Score

74

HIGH

(45-100)

100

44

High Moderate Low

74

Vectra Score Interpretation

Patient has a High Vectra Score and is at increased

risk for radiographic progression.

29

1

Jul 2020

Consider adjusting treatment regimen to reduce

inflammation and retesting at the next clinical

visit.

NO BASELINE VECTRA SCORE 74

1-YR RISK OF RAPID RP*

HIGH

(45-100)

MODERATE

(30-44)

LOW

(1-29)

7- 47%

4-6%

1-3%

The radiographic progression risk ranges were determined with data from 953 RA patients of whom 76% were seropositive

and 24% were seronegative. Risk will generally be higher for seropositive patients and lower for seronegative.

*Radiographic progression is assessed by validated Sharp score method. A change in Sharps score of >5 is considered rapid RP.

Risk for Rapid RP Increases as the Patient’s Vectra Score Increases

14

PATIENT SCENARIO 2

Vectra ® Score

43

MODERATE

(30-44)

100

44

29

1

32

High Moderate Low

Meaningful Change

≥8 Units

43

Dec 2019 Jul 2020

Vectra Score Interpretation

Patient has a Moderate Vectra Score that increased

by 8 or more units from the previous score, which

was also in the Moderate category. The patient has

limited risk for radiographic progression.

Consider adjusting treatment regimen to reduce

inflammation or observing the patient and

retesting at next clinical visit.

BASELINE 32

VECTRA SCORE 43

1-YR RISK OF RAPID RP*

HIGH

(45-100)

MODERATE

(30-44)

LOW

(1-29)

7- 47%

4-6%

1-3%

The radiographic progression risk ranges were determined with data from 953 RA patients of whom 76% were seropositive

and 24% were seronegative. Risk will generally be higher for seropositive patients and lower for seronegative.

*Radiographic progression is assessed by validated Sharp score method. A change in Sharps score of >5 is considered rapid RP.

Risk for Rapid RP Increases as the Patient’s Vectra Score Increases

Vectra

Enhanced Care

15

Vectra Enhanced Care: Utilizing Molecular,

Physician and Patient Assessments

PATIENT ASSESSMENT

MOLECULAR ASSESSMENT

Vectra

Enhanced

Care

PHYSICIAN ASSESSMENT

Utilizing a molecular assessment along with

a physician assessment and a patient assessment

provides the most comprehensive view

of a patient’s RA inflammation.

16

Intended Use

MANAGEMENT DECISION

Patient and provider agree to make a treatment change

Baseline at time of treatment change decision

Therapy Initiation or Change: Until the desired treatment target

is reached, drug therapy should be adjusted every 3-6 months

THERAPY MONITORING

Evaluate if treatment is working

Test at 3-6 months after treatment change

to evaluate if treatment is working

Achieving a state of disease remission

in RA is considered a primary treatment goal

LOW DISEASE ACTIVITY MONITORING

Evaluate that patient remains within treatment goal

Continue to test patient two times

a year once in low activity

Monitor that patient is

remaining within treatment goal

17

Vectra Patient Testing Pathway 12

Test on initial visit

& routine exam

LOW (1-29) MODERATE (30-44)

HIGH (45-100)

Test every 6 to 12

months on follow-up

visits

Manage based on a

meaningful change

in score

Test every

3 months until

disease activity

reduced to low/

moderate level

Provide Your RA Patients with Better Outcomes

Bridge

Communication Gaps

Quantify

Treatment Response

Patient Risk

Stratification

Medical Management

Decisions

18

Vectra: Your Multi-Assessment Tool to Help You

Reach Your Treat-to-Target Goals

MEASURE

INFLAMMATION

CARDIOVASCULAR

RISK

Baseline for

Newly Diagnosed

RA Patient

Tapering

Future

Radiographic

Progression Risk

Conundrum

Patient

Treatment

Change

Monitor

Treatment

Success

Ensure success of controlling rheumatoid arthritis

inflammation by using Vectra at initiation, change in drug

therapy and monitor response to therapy.

19

Provider Resources

VectraView®

VectraView is an online analytical tool that enables you to draw insights from Vectra results

at the individual patient or practice level. VectraView allows you to:

• Access all of your patients’ Vectra results in one place through a convenient online portal

• Store and access disease activity measurements alongside Vectra results

• View Vectra Scores displayed in the context of your patients’ medications

• View Vectra results for all tested patients in one view and filter to identify patients for follow-up

www.labcorp.com/vectra

A secure, mobile-optimized web application that lets you:

• Order tests and receive result reports

• Order supplies

• View on-screen visual cues with specimen

collection instructions (AccuDraw)

• Pay a bill and access billing forms

Provider Support

A team of highly trained

medical liaisons is available

for consultation. For questions

associated with the Vectra

Test, please contact

Customer Service.

Phone: 1-877-743-8639

References:

1. Cardarelli WJ. Managed care decision makers: Understanding the full scope of rheumatoid arthritis management. AJMC. https://www.ajmc.com/view/managed-care-decision-makers-understanding-the-full-scope-of-rheumatoidarthritis-management-articles.

Published July 16, 2017. Accessed October 15, 2021. 2. Vandever L. Rheumatoid arthritis by the numbers. Healthline. https://www.healthline.com/health/rheumatoid-arthritis/facts-statistics-infographic.

Published July 21, 2021. Accessed October 15, 2021. 3. Journal of Vocational Rehabilitation 30 DOI 10.3233/JVR-2009-0458 page 123. 4. Smolen JS, et al., Treating rheumatoid arthritis to target: 2014 update of the recommendations of

an international task force. Ann Rheum Dis. 2016 Jan;75(1):3-15. doi: 10.1136/annrheumdis-2015-207524. Epub 2015 May 12. PMID: 25969430; PMCID: PMC4717393. 5. Kvrgic, Z et al. “Like No One Is Listening to Me”: A Qualitative Study

of Patient-Provider Discordance Between Global Assessments of Disease Activity in Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1439-1447. doi: 10.1002/acr.23501. Epub 2018 Sep 4. PMID: 29266857; PMCID:

PMC6013318. 6. Challa, DN et al. Patient-provider discordance between global assessments of disease activity in rheumatoid arthritis: a comprehensive clinical evaluation. Arthritis Research & Therapy (2017) 19:212. doi:10.1186/

s13075-017-1419-5. 7. O’Neill, K.D., et al. (2021), Importance of Shared Treatment Goal Discussions in Rheumatoid Arthritis—A Cross-Sectional Survey: Patients Report Providers Seldom Discuss Treatment Goals and Outcomes Improve

When Goals Are Discussed. ACR Open Rheumatology. https://doi.org/10.1002/acr2.11335. 8. Adapted from Kay J, et al. Clinical disease activity and acute phase reactant levels are discordant among patients with active rheumatoid

arthritis: acute phase reactant levels contribute separately to predicting outcome at one year. Arthritis Res Ther. 2014 Feb 3;16(1): R40. doi: 10.1186/ar4469. PMID: 24485007; PMCID: PMC3978994. 9. Brown, A.K., Conaghan, P.G., Karim, Z.,

Quinn, M.A., Ikeda, K., Peterfy, C.G., Hensor, E., Wakefield, R.J., O’Connor, P.J. and Emery, P. (2008), An explanation for the apparent dissociation between clinical remission and continued structural deterioration in rheumatoid arthritis.

Arthritis & Rheumatism, 58: 2958-2967. https://doi.org/10.1002/art.23945. 10. Curtis, et al. Adjustment of the multi-biomarker disease activity score to account for age, sex, and adiposity in patients with rheumatoid arthritis. Oxford

Academic, Rheumatology, 2018: December, 24. 11. Curtis JR, Weinblatt ME, Shadick NA, Brahe CH, Østergaard M, Hetland ML, Saevarsdottir S, Horton M, Mabey B, Flake DD 2nd, Ben-Shachar R, Sasso EH, Huizinga TW. Validation of the

adjusted multi-biomarker disease activity score as a prognostic test for radiographic progression in rheumatoid arthritis: a combined analysis of multiple studies. Arthritis Res Ther. 2021 Jan 4;23(1):1. doi: 10.1186/s13075-020-02389-4.

PMID: 33397438; PMCID: PMC7784276. 12. Chernoff, D., Scott Eastman, P., Hwang, C.C. et al. Determination of the minimally important difference (MID) in multi-biomarker disease activity (MBDA) test scores: impact of diurnal and daily

biomarker variation patterns on MBDA scores. Clin Rheumatol 38, 437–445 (2019).

© 2022 Laboratory Corporation of America® Holdings. All rights reserved. L27557-0122-1

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Helping provide better

patient care with a

consultative approach

Labcorp’s coagulation services provide a

broad spectrum of expertise in hemostasis

testing.

Innovation

Labcorp is committed to maintaining its leadership in coagulation

testing.

Hemophilia Assessment

Unique inhibitor profiles and hemophilia replacement product

assays

Abnormal APTT/PT Evaluation

An algorithmic, physician-directed approach to help identify the

basis for abnormal APTT/PT screening assays

Bleeding Diathesis Diagnosis

Esoteric assays help detect abnormalities in various pathways

to determine a patient’s hemorrhagic risk

von Willebrand's Disease

Variety of assays including multimer analysis and collagen

binding activity with pathologist review

Pediatric Profiles (Bleeding and Clotting)

Specialized test combinations with minimum volume

requirements

Direct Oral Anticoagulants (DOAC)

Leaders in the investigation and publication of peer-reviewed

literature about DOAC measurement and interference in special

coagulation assays

Scientific Expertise

We have more than 40 years of experience offering distinctive

services with a consultative focus.

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hemostasis testing accessible for expert consultation

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Superior Service

Labcorp’s national infrastructure allows for a seamless,

integrated service that makes it easier for providers to manage

their coagulation testing needs.

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pathologist interpretations

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Scientific Team

On-staff, board-certified pathologists

experienced in hemostasis testing

accessible for expert consultation

Test Name Test Includes Test No. Specimen Volume

Abnormal PT/aPTT

Reflexive Profile

(Esoterix)

aPTT

PT/INR

dRVVT

Pathologist Interpretation

Thrombin Time

(Additional assays will be performed as necessary to

determine the cause of the abnormality. † )

Hexagonal Phospholipid Neutralization

503335

Citrated

plasma, frozen

Three 1 mL platelet-poor frozen

tubes

Antiphospholipid

Syndrome (APS),

Comprehensive

(Esoterix)

Bleeding Diathesis With

Normal aPTT/PT Profile

(Esoterix)‡

Fibrinogen Evaluation

Profile III (Esoterix)

Fibrinolysis Profile II

(Esoterix)

Intrinsic Pathway

Coagulation Factor

Profile (Esoterix)

Lupus Anticoagulant/

Cardiolipin Antibody

(Esoterix)

Markers of Coagulation

Activation (Esoterix)

aPTT (If prolonged, aPTT will reflex to Immediate

aPTT Mixing Studies. † )

Anticardiolipin Antibody, IgA/G/M

Antiphosphatidylserine, IgG/M

Antiprothrombin Antibody, IgG

α2-Antiplasmin Assay

Euglobulin Lysis Time

Factor VIII Activity

Factor VIII Chromogenic

Factor IX Activity

Factor XI Activity

Fibrinogen Activity

Fibrinogen Antigen

Reptilase Time

α2-Antiplasmin

D-dimer Quantitative (Automated)

Euglobulin Lysis Time

Fibrin Degradation Products


Factor IX Activity

aPTT (If prolonged, aPTT will reflex to

Immediate aPTT Mixing Studies. † )

Anticardiolipin Antibody, IgG/M

β2-Glycoprotein I, IgA/G/M

dRVVT

D-dimer Quantitative (Automated)

Prothrombin Fragment 1+2 MoAb


dRVVT


Lupus Anticoagulant Interpretation

Platelet Neutralization Procedure

Factor XIII Activity

Fibrinogen Activity

PAI-1 Activity (Reflex to PAI-1 Antigen and Tissue Plasminogen

Activator (tPA) Antigen)

von Willebrand Factor Activity

von Willebrand Factor Antigen

Thrombin Time Mixing Studies

(Thrombin Time 1:1 NP), Thrombin Time — Heparin

Neutralization

PAI-1 Activity

Plasminogen Activity

tPA Antigen

Factor XI Activity

Factor XII Activity



PT/INR

Thrombin Time

504400

Serum and

plasma, frozen

503541 Plasma, frozen

Three 2 mL each frozen citrated

plasma tubes and two 1mL

tubes frozen serum

7 mL platelet-poor frozen

citrated plasma divided into

seven tubes

500700 Plasma, frozen Two tubes 1 mL each

502360 Plasma, frozen

Four 2 mL platelet-poor, frozen

tubes

500705 Plasma, frozen Two tubes of 1 mL each

500711

Plasma and

serum, frozen

Thrombin-Antithrombin Complex 500604 Plasma, frozen 2 mL

Three tubes of citrated plasma

with 2 mL each and 2 mL serum

Oral Contraceptive /

Hormone Replacement

Therapy Thrombotic

Risk Profile II (Esoterix)

Antithrombin (AT) Activity

Factor II Gene Mutation

Factor V Leiden

Pathologist Interpretation

Protein C Activity (Chromogenic)

Protein S Antigen, Free

502343

Plasma and

whole blood

EDTA

3 mL platelet-poor frozen

citrated plasma divided into

three 1 mL tubes and 5 mL

whole blood

Recurrent Miscarriage

/ Fetal Demise Profile

(Esoterix)

ThrombAssure Inherited

Venous Thrombosis

Profile (Esoterix)

Venous Thrombosis

(Hypercoagulability)

Profile for Patients on

Vitamin K Antagonist

(VKA) Therapy

(Esoterix)‡

von Willebrand Disease

Reflexive Profile

Pathologist

Interpretation

aPTT (If prolonged, aPTT will reflex

to Immediate aPTT Mixing Studies. † )

Anticardiolipin Antibody, IgA/G/M

Antiphosphatidylserine, IgG/M



dRVVT



Factor V Leiden

Antithrombin Activity

APC-Resistance (Reflex to Factor V Leiden if APCR

is abnormal)






dRVVT

APC-Resistance (Reflex to Factor V Leiden if APCR

is abnormal)






dRVVT


Factor V Leiden

Factor XIII Activity


Homocysteine


PAI-1 Activity

Protein C Activity (Chromogenic)


Protein C Activity





Homocysteine


Protein C Activity (chromogenic)




Homocysteine


Protein C Antigen

Protein S Antigen, Total

Factor VII Antigen

Protein C Antigen/Factor VII Antigen Ratio

Protein S Antigen/Factor VII Antigen Ratio

Factor VIII Activity; von Willebrand Ristocetin Cofactor Activity; von Willebrand Factor Antigen, pathologist interpretation;

with reflex to Collagen-binding Activity Profile and von Willebrand Factor (vWF) Multimers if abnormal results are suggestive

of von Willebrand Disease

502051

501496

501790

501768

504808

Pathologist interpretation can be added to any of the profiles above by ordering 500683 500683

Serum, plasma,

and whole

blood

Plasma and

whole blood

EDTA

Serum, plasma,

and whole

blood

Serum, plasma,

and whole

blood

Citrated

plasma, frozen

Five 1 mL tubes of platelet-poor

frozen citrated plasma and 5

mL whole blood EDTA and 2

mL frozen serum

2 tubes 1mL each frozen

citrated plasma, 5mL EDTA

whole blood

Three 2 mL platelet-poor,

frozen citrated plasma tubes,

5 mL whole blood EDTA, and 2

mL frozen serum

6 mL (2 mL in each of three

tubes) platelet-poor citrated

plasma, frozen, 5 mL whole

blood EDTA, and 2 mL serum,

frozen

Two tubes of 2 mL each

† If reflex testing is performed, additional charge(s)/CPT code(s) may apply.

‡ This procedure may be considered by Medicare and other carriers as investigational

and, therefore, may not be payable as a covered benefit for patients.

Please contact your local account

representative for more information, or visit

specialtytesting.labcorp.com/services/coagulation


CASCADE

TESTING

OPTIONS

LabCorp offers test cascade protocols for:

Cardiovascular

Cervical Cancer

HIV/HCV

Syphilis

Thyroid

EVIDENCE-BASED | COST-EFFECTIVE

LabCorp offers a variety of testing cascades to assist clinicians

with patient assessment, diagnosis, and care coordination.

LabCorp is among the first to offer these automated, sequential, and cost-effective reflex test

groups that use evidence-based protocols to determine specific additional tests based on

results of the previously performed test.*

The use of clinical laboratory cascades may help improve the quality and efficiency of care

delivered to patients by:

• Facilitating clinical practice improvements by assisting with decision support

• Decreasing cost-of-care by reducing unnecessary testing

• Increasing quality by using evidence-based cascades for automated testing, including

recommended test changes with guideline updates

• Increase efficiency as all testing is performed on the original specimen, obviating the

inconvenience and expense of return visits for additional specimen collections

*If reflex testing is performed, additional charges/CPT code(s) may apply.

Clinical laboratory results

drive nearly 70% of medical

decisions. Clinicians need a

clinical laboratory partner

with the scale, technology,

and resources to support

accountability for quality

metrics, care coordination,

outcomes and costs to

optimize success under the

Medicare Access and CHIP

Reauthorization Act of

2015 (MACRA).

Lipid Cascade - Cardiovascular Risk Management for At-Risk Patients

Cascade testing in high-risk patients,

including patients with insulin

resistance, metabolic syndrome, type

2 diabetes, may assist clinicians with

decision support.* Requiring a single

blood draw, LabCorp’s Lipid Cascade

options offer convenient, step-wise

testing by reflexing from a traditional

lipid panel to lipoprotein particle

testing by nuclear magnetic resonance

(NMR) or apo B (depending upon the

ordered test option) when the LDL

value is < 130mg/dL.

*Physicians should review the specific

implications of MACRA and its regulations

with their own practice advisors. CMS

provides many educational tools.

See www.cms.gov for more information.

Conventional lipid panel

Total cholesterol, triglycerides,

HDL, LDL calculation, LDL/HDL

ratio, Non-HDL calculation

LDL < 130mg/dL

Reflex**

If triglycerides > 400 mg/dL

Reflex**

Lipoprotein assessment by

NMR to evaluate LDL number

or assessment by Apo B

Reflex**

Direct LDL if < 130 mg/dL

**If reflex testing is performed, additional charges/CPT code(s) may apply.

Statin Therapy for the

Prevention and Treatment of

Cardiovascular Disease is a

MACRA quality metric.

2

ENHANCED CLINICAL OUTCOMES

Thyroid Cascade Testing

LabCorp’s thyroid cascade results

reports assist clinicians with decision

support though report annotation that

alerts the clinician to other conditions

that may influence final test results.

Low

Low

FT4

Normal

High

TSH

Normal

Euthyroid

High

FT4

Low Normal High

TSH testing* is recommended

by the American Thyroid

Association. 1

*Beginning at age 35 years and every 5 years

thereafter. 1

FT3

Secondary

Hyperthyroidism

Severe illness

FT3

Hyperthyroidism

Hypothyroidism

Negative

Anti-TPO

TSH Secreting

Tumor

Positive

Low Normal High

Subclinical

Hypothyroidism

Secondary

Hypothyroidism

Severe illness

T3

Thyrotoxicosis

Subclinical

Hypothyroidism

Severe illness

Subclinical

Hyperthyroidism

Severe illness

**Cascade not intended for pediatric patients, monitoring

patients receiving treatment for thyroid disease with

either ablative or suppressive therapy, or to diagnose

primary thyroid neoplasm.

3


Cervical Cancer and Sexually Transmitted Diseases (STDs) Cascades

LabCorp offers age-based test protocol for cervical cancer and sexually transmitted disease screens. Chlamydia and

gonorrhea testing, a component of MACRA measures, are performed with the cascade - depending on age.

Age 21-24

Age 25-29

Age 30-65

Image-guided Pap

Image-guided Pap

Image-guided Pap

Chlamydia/Gonorrhea

If Pap is ASCUS

High-risk HPV

If Pap is ASCUS

If Pap - and HPV+

Reflex to HPV high-risk

Reflex to HPV high-risk

Reflex to HPV 16/18, 45

Age-based cascade based on the American College of

Obstetricians and Gynecologists (ACOG) guidelines. 2-4

4


Treponema pallidum (Syphilis) Screening Cascade

LabCorp’s T. pallidum screening cascade results report include detailed interpretation with

individual patient recommendations to assist clinicians with early detection and care coordination.

Treponema pallidum

Screening Cascade

Negative

Equivocal

(after repeated testing)

Positive

Stop

Low-risk patient:

Negative for syphilis Ab.

Low levels of Ab detected;

infection suspected; Retest

in two to four weeks.

Negative

Positive/Equivocal

High-risk patient: Negative for syphilis Ab;

cannot exclude incubation during early

primary syphilis. If syphilis infection is

strongly suspected, retest in one month.

Stop: Possible

false-positive result.

Nontreponemal test:

Qualitative RPR

Positive

Negative

Positive Equivocal Negative

Possible previously

treated syphilis, early

primary, or late latent

syphilis. If no history of

previously treated syphilis

or history unknown,

recommended

treatment as late

latent syphilis.

Different treponemal test:

TrepSure®

Low levels of antibodies

detected; infection is

suspected. If no history of

previously treated syphilis

or history unknown, retest

in one month, or treat as

late latent syphilis.

Possible false-positive

result. Stop if low-risk

patient. If syphilis is

strongly suspected, retest

in one month, or treat as

late latent syphilis.

Quantitative

nontreponemal

test: RPR titer

Past or current syphilis

infection. Sequential

RPR quantitative

testing recommended

to monitor treatment

effectiveness using

change in titers.

Legend

Test Names

Test Results

Actions

Figure 1 - New Syphilis Screening Cascade

Treponema pallidum Screening Cascade utilizes the Centers for Disease Control and Prevention (CDC)

and the Association of Public Health Laboratories guidelines. 5,6

5


Human Immunodeficiency Virus (HIV) Cascade

LabCorp’s HIV cascade includes detection of acute infections using fourth-generation HIV screening assay which improves

accuracy of the diagnosis of HIV infections. 7 Step-wise screening may lead to earlier diagnosis and intervention.

HIV-1/2 Antigen/Antibody Combination Immunoassay

(+) (-)

HIV-1/HIV-2 antibody

differentiation immunoassay

Negative for HIV-1 and HIV-2

antibodies and p24 Ag

HIV-1 (+)

HIV-2 (-)

HIV-1 (-)

HIV-2 (+)

HIV-1 (+)

HIV-2 (+)

HIV-1 (-) or indeterminate

HIV-2 (-)

HIV-1 antibodies

detected

(+) indicates reactive test result

(-) indicates nonreactive test result

NAT: nucleic acid test

HIV-2 antibodies

detected

HIV antibodies

detected

HIV-1 NAT (+)

Acute HIV-1 infection

HIV-1 NAT

HIV-1 NAT (-)

Negative for HIV-1

HIV-1/2 Antigen/Antibody Combination (4th generation) Immunoassay

follows the CDC’s recommended laboratory HIV testing algorithm. 7

6


Hepatitis C Virus (HCV) Cascade

LabCorp HCV is an initial screen using an FDA-approved antibody test. 8 For any positive antibody result, the CDC recommends

using an FDA-approved NAT—also called an HCV RNA test—to identify active HCV infection. 8

Hepatitis C Virus (HCV) Antibody Cascade

to Quantitative PCR and Genotyping

Antibody

Negative

Antibody

Positive

HCV Quantitative PCR

≥1,000 IU/mL

HCV Genotype

Hepatitis C Virus (HCV) Antibody Cascade

to Quantitative PCR and Genotyping

follows the CDC’s and the

AASLD testing

recommendation

for hepatitis C

virus infection. 8,9

Genotypes 1-6

Services

Physician access to referred patients’ test results

through LabCorp Link TM

Global patient search is a feature of LabCorp Link that allows an

authorized physician to have access to lab results that may have

been ordered by other physicians for a referred patient.

Global Patient Search* allows you to:

• Search for a referred patient’s lab test based on several

search parameters

• Review results of the referred patient, gaining a more

complete clinical picture of the patient’s health

• Minimize the time you and your staff spend requesting

copies of patients’ lab results.

* For a Global Patient Search feature, a physician must have a LabCorp

Link account, and the physician must agree to the Global Search Terms of

Use. Global search is only permitted when the physician is in a treatment

relationship with the patient.

Litholink

Litholink provides clinical decision support and outcome reporting to

aid in the management of cardiovascular disease.

Web-based connectivity and systems integration

LabCorp offers electronic connectivity solutions to assist your

practice in test ordering and result delivery.

Connectivity Solutions

• LabCorp Link TM - Online lab test ordering and result reporting

LabCorp Link lets you order, view, share, manage, and analyze

lab results - anytime, anywhere. LabCorp Link offers

trending and powerful analytic features. Sequential

trending and graphic representations let you see a patient’s

results over time to help recognize important patterns.

Powerful analytics allow you to:

- Find and compare members of your patient population by

test, by result, or by diagnosis.

- Trend the historical test results for a single patient, including

results of tests ordered by other providers.

• Systems integration - Interfaces with more than 700

solutions to connect LabCorp with your EMR

For additional information, ask your sales

representative or visit www.LabCorp.com.

7

Test Options

Cardiovascular

123836 Lipid Cascade With Reflex to Lipoprotein Particle Assessment by NMR (With Graph)

363676 Lipid Cascade With Reflex to Apolipoprotein B

Cervical Cancer

193060 Gynecologic Pap Test-Age-based Guideline for Cervical Cancer (Aptima®) and STDs

193065 Gynecologic Pap Test-Age-based Guideline for Cervical Cancer (Aptima®)

193070 Gynecologic Pap Test-Age-based Guideline for Cervical Cancer (Aptima®) Plus Chlamydia/Gonococcus

193075 Gynecologic Pap Test-Age-based Guideline for Cervical Cancer (Aptima®) Plus Chlamydia/Gonococcus/Trichomonas

HIV/HCV

083935 Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antigen/Antibody (Fourth Generation) Preliminary Test With

Cascade Reflex to Supplementary Testing

144127 Hepatitis C Virus (HCV) Antobody Cascade to Quantitative PCR and Genotyping

Syphilis

082345 Treponema pallidum (Syphilis) Screening Cascade

082370 Treponema pallidum Antibodies

006379 Treponema pallidum Antibodies (FTA-ABS)

006072 Rapid Plasma Reagin (RPR), Qualitative Test

006460 Rapid Plasma Reagin (RPR), Quantitation

012005 Rapid Plasma Reagin (RPR) Test With Reflex to Quantitative RPR and Confirmatory Treponema pallidum Antibodies

Thyroid

330015 Thyroid Cascade Profile

140749 Thyroid-stimulating Immunoglobulin (TSI)

For the most current information regarding test options, including specimen requirements and CPT codes, please consult the online test menu at

www.LabCorp.com

References

1. Ladenson PW, Singer PA, AIN KB. American Thyroid Association guidelines for detection of thyroid dysfunction. Arch Intern Med. 2000 Jun 12; 160(11):1573-1575.

2. American College of Obstetricians and Gynecologists. Cervical Cancer Screening and Prevention. ACOG Practice Bulletin. No. 168, October 2016. Obstet Gynecol. 2016 Oct; 128(4):

1-20.

3. American College of Obstetricians and Gynecologists. Annual Women’s Health Care Ages 19-39: Exams and screening tests. https://www.acog.org/About-ACOG/ACOG-Departments/

Annual-Womens-Health-Care/FOR-PATIENTS/Pt-Exams-and-Screening-Tests-Age-19-39-Years. Accessed August 22, 2017.

4. American College of Obstetricians and Gynecologists. Management of abnormal cervical cancer screening test results and cervical cancer precursors. ACOG Practice Bulletin. No. 140,

December 2013. Obstet Gynecol. 2013 Dec; 122(6):1338-1367.

5. Association of Public Health Laboratories. Laboratory Diagnostic Testing for Treponema pallidum: Expert Consultation Meeting Summary Report. Atlanta, Ga, January 13-15, 2009.

6. Centers for Disease Control and Prevention. Syphilis testing algorithms using treponemal tests for initial screening — four laboratories, New York City, 2005-2006. [Editorial Note]

MMWR. 2008 Aug 15; 57(32):872-875.

7. Centers for Disease Control and Prevention (CDC) and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations.

Available at http:dx.doi.org.15620/cdc.23447. Published June 27, 2014.

8. Centers for Disease Control and Prevention. Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945-1965. MMWR 2012;61

(No. RR-4):1-32.

9. American Association for the Study of Liver Diseases (AASLD); Infectious Diseases Society of America (IDSA).Recommendations for Testing, Managing, and Treating Hepatitis C. HCV

testing and Linkage to care. Available at http://www.hcvguidelines.org. Updated July 6, 2016. Accessed April 28, 2017.


CLINICAL DRUG TESTING

Labcorp

MedWatch®: ToxAssure®

Test options to help monitor a wide range

of patients and medication use


Labcorp

MedWatch®: ToxAssure®

Labcorp’s MedWatch program is designed to assist you as you care for patients taking controlled

substances. Our ToxAssure test options are designed to monitor medication compliance, as well

as to identify potentially dangerous drug interactions.

Your patients aren’t all the same, and we understand that your lab testing shouldn’t be, either. Our ToxAssure

portfolio combines a wide range of drug classes and methodologies to give you the flexibility you want with the

confidence you need.

Service Beyond Testing

Our toxicology experts are available to you and your staff

Medical Drug Monitoring Support Line

877-474-5767

MedWatchMTX@Labcorp.com

Extensive menu: Testing for more than 200 drug compounds

Blood and oral fluid test options: Available for patients who are unable to provide urine samples.

Test Name ToxAssure Flex 15 ToxAssure Flex 23 ToxAssure Select

ToxAssure

Comprehensive

Test No. 912334 912335 738526 790600

Prescribed medication

interpretation report

Included Included Included Included

Test methodology

Immunoassay performed

and CPT 80307 billed

No. of definitive tests

performed

Specimen

Presumptive (P), Presumptive with reflex to definitive

(P rfx D), Direct to definitive for some drug classes (DD)

Direct to definitive (DD), Presumptive with reflex to

definitive (P rfx D) used on some drug classes

Yes Yes Yes Yes

3 plus additional if reflexed 6 plus additional if reflexed 14 27

30 mL random urine; Minimum: 3 mL

Container Urine container, with temperature strip. 90 mL snap lid with bag (No. 106494)

Specimen validity testing

Creatinine with normalized drug concentration

ToxAssure

Flex 15

ToxAssure

Flex 23

ToxAssure

Select

ToxAssure

Comprehensive

Drug Classes

Presumptive

Detection

Threshold

Definitive

Detection

Thresholds

P P P P Alcohol, Ethyl* 0.02 g/dL ethyl alcohol

P rfx D Ethanol biomarkers 500 ng/mL

500 ng/mL

75 ng/mL

Drug Metabolites Included

ethyl glucuronide (EtG)

ethyl sulfate (EtS)

P rfx D P rfx D P rfx D P rfx D 6-acetylmorphine 10 ng/mL 10 ng/mL 6-acetylmorphine

P rfx D P rfx D DD DD Amphetamines* 300 ng/mL 50 ng/mL

P rfx D P rfx D P rfx D P rfx D Barbiturates 200 ng/mL 200 ng/mL

DD DD DD DD Benzodiazepines* 20 ng/mL

DD DD DD DD Buprenorphine*

P rfx D P rfx D P rfx D P rfx D Cannabinoids (THC)*

20 ng/mL

1 ng/mL

5 ng/mL

2 ng/mL

methamphetamine, amphetamine,

methylenedioxymethamphetamine (MDMA),

methylenedioxyamphetamine (MDA)

amobarbital, barbital, butabarbital, butalbital, mephobarbital,

pentobarbital, phenobarbital, secobarbital, thiopental

alprazolam, alpha-hydroxyalprazolam, chlordiazepoxide

(as metabolites desmethyldiazepam and oxazepam),

clonazepam, 7-aminoclonazepam, clorazepate (as metabolites

desmethyldiazepam and oxazepam), desalkylflurazepam,

diazepam, desmethyldiazepam, flunitrazepam,

desmethylflunitrazepam, lorazepam, midazolam,

alpha‐hydroxymidazolam, oxazepam, temazepam, alphahydroxytriazolam

buprenorphine

norbuprenorphine

total metabolites

∆9-carboxy-tetrahydrocannabinol (carboxy-THC)

P rfx D P rfx D DD DD Cocaine & Metabolite* 150 ng/mL 50 ng/mL cocaine, benzoylecgonine, cocaethylene

DD DD DD DD Fentanyl & Analogues*

1 ng/mL

5 ng/mL

fentanyl

norfentanyl, sufentanil, alfentanil

P rfx D P rfx D DD DD Methadone* 100 ng/mL 50 ng/mL methadone, EDDP (methadone metabolite)

P rfx D P rfx D DD DD Opiate Class* 100 ng/mL 50 ng/mL

codeine, norcodeine, dihydrocodeine, hydrocodone,

norhydrocodone, hydromorphone, morphine, normorphine

P rfx D P rfx D DD DD Oxycodone Class* 100 ng/mL 50 ng/mL oxycodone, oxymorphone, noroxycodone, noroxymorphone

P rfx D P rfx D DD DD Tapentadol* 200 ng/mL 50 ng/mL tapentadol

P rfx D P rfx D DD DD Other Opioids (tramadol) 200 ng/mL 50 ng/mL tramadol, o-desmethyltramadol, n-desmethyltramadol

P rfx D (PCP)

P rfx D

meperidine,

propoxyphene

P

acetaminophen

P rfx D

gabapentin

P rfx D

carisoprodol

P rfx D (PCP)

DD (ketamine)

DD

DD

DD

P: salicylate

DD: others

Other Opioids (additonal

compounds)

Analgesics/NSAIDS

200 ng/mL,

meperidine and

propoxyphene

5 µg/mL

acetaminophen

3.0 mg/dL salicylate

DD Anticonvulsants 1 µg/mL gabapentin

DD

DD

DD

Antidepressants

Antihistamines

Antipsychotics

50 ng/mL

100 ng/mL

150 ng/mL

0.5 µg/mL

1.0 µg/mL

3.0 mg/dL

50 ng/mL

300 ng/mL

1.0 µg/mL

50 ng/mL

100 ng/mL

50 ng/mL

100 ng/mL

10 ng/mL

50 ng/mL

100 ng/mL

butorphanol, nalbuphine, naltrexone, meperidine

normeperidine, pentazocine

levorphanol (see dextrorphan/levorphanol)

propoxyphene, norpropoxyphene

diclofenac, ketoprofen

acetaminophen, ibuprofen, naproxen, oxaprozin

salicylate

clobazam, tiagabine

carbamazepine

ezogabine (retigabine), gabapentin, lamtotrigine,

levetiracetam, oxcarbazepine MHD (10-monohydroxy

metabolite), phenytoin, pregabalin, primidone, rufinamide,

topiramate, zonisamide

amitriptyline, amoxapine, clomipramine,

desmethylclomipramine, desipramine, duloxetine,

imipramine, nefazodone, nortriptyline, trazodone,

1,3-chlorophenylpiperazine (trazodone/nefazodone

metabolite), vilazodone

8-hydroxyamoxapine, bupropion, hydroxybupropion,

citalopram/escitalopram, desmethylcitalopram,

desmethylvenlafaxine/desvenlafaxine, doxepin,

desmethyldoxepin, fluoxetine, norfluoxetine, fluvoxamine,

maprotiline, mirtazapine, paroxetine, protriptyline, sertraline,

desmethylsertraline, trimipramine, venlafaxine

brompheniramine, hydroxyzine, promethazine, pyrilamine

chlorpheniramine, diphenhydramine, doxylamine, triprolidine

aripiprazole, chlorpromazine, fluphenazine, perphenazine,

prochlorperazine, trifluoperazine, ziprasidone

haloperidol, loxapine, 8-hydroxyloxapine, risperidone

asenapine, clozapine, desmethylclozapine, iloperidone,

lurasidone, mesoridazine, molindone, olanzapine, pimozide,

quetiapine, thioridazine, thiothixene

DD Local Anesthetics 100 ng/mL bupivacaine, lidocaine, mepivacaine, procaine

DD

Muscle Relaxants

100 ng/ml

carisoprodol

DD Other Hallucinogens 25 ng/mL

DD

DD

DD

Sedative/

Hypnotics

Sympathomimetics

Additional

Miscellaneous

Compounds

Ethanol biomarkers

(Test No. 738754)

Frequently Ordered Add-on Testing

500 ng/mL

*Denotes drug classes that are reported quantitatively

Note: d- and l-methamphetamine stereoisomer testing can be added, by request or by reflex, when methamphetamine is positive

50 ng/mL

300 ng/mL

300 ng/mL

25 ng/mL

5 ng/mL

50 ng/mL

100 ng/mL

100 ng/mL

300 ng/mL

50 ng/mL

100 ng/mL

300 ng/mL

1.0 µg/mL

500 ng/mL

75 ng/mL

cyclobenzaprine, desmethylcyclobenzaprine, metaxolone,

orphenadrine, tizanidine

baclofen, carisoprodol, meprobamate, methocarbamol

ketamine, norketamine

phencyclidine (PCP)

zaleplon, zolpidem, zolpidem acid

zopiclone/eszopiclone

amino chloropyridine (zopiclone/eszopiclone breakdown

product)

atomoxetine, diethylpropion, methylphenidate,

phenylpropanolamine

methylenedioxyethylamphetamine (MDEA), ephedrine/

pseudoephedrine, methcathinone, phenmetrazine,

phentermine, ritalinic acid (methylphenidate metabolite)

benztropine, clonidine

dextromethorphan, dextrorphan/levorphanol, verapamil

atenolol, diltiazem, guaifenesin, metoprolol, milnacipran,

propranolol, theophylline

caffeine (large amounts)

ethyl glucuronide (EtG), ethyl sulfate (EtS)

ToxAssure Sample Report

The ToxAssure report format provides ease of review and evaluation of drug testing

results related to a patient’s prescribed medication and nonprescribed drug use.

Page 1: Report Summary

1

2

3

4

5

8

PATIENT

TEST, EXAMPLE

PATIENT ID: T0000 Age: 00

EXAMPLE REPORTS

MEDTOX LABORATORIES, INC. 402 W. COUNTY ROAD D, NEW BRIGHTON, MN 55112

ACCESSION NUMBER: S0000000 REQUISITION NUMBER: S0000000

RECEIVED: 0/0/0000 00:00 PM Report Status: FINAL

ToxAssure Comp Drug Analysis,UR

Drug Result Unit of measure where result is quantitative is ng/mg creatinine

EXPECTED

Oxycodone 1000

Oxymorphone 200

Noroxycodone 1000

Noroxymorphone 100

Pregabalin

PRESENT

Duloxetine

UNEXPECTED

Carboxy-THC 25

Tapentadol 300

UNEXPECTED

Alprazolam

DRUG PRESENT AND DECLARED FOR PRESCRIPTION VERIFICATION

PRESENT

DRUG PRESENT NOT DECLARED

DRUG ABSENT BUT DECLARED

Not Detected

Sources of oxycodone are scheduled prescription medications. Oxymorphone,

noroxycodone, and noroxymorphone are expected metabolites of oxycodone.

Oxymorphone is also available as a scheduled prescription medication.

FOR PRESCRIPTION VERIFICATION

Carboxy-THC is a metabolite of tetrahydrocannabinol (THC). Source of THC is

most commonly illicit, but THC is also present in a scheduled prescription

medication.

Source of tapentadol is a scheduled prescription medication.

Not detected result may be consistent with the time of last use noted for this

medication.

PATIENT ID: T0000 Age: 00

Test

TEST, EXAMPLE

00/00/0000 F 0/0/0000 DOCTOR, TEST

Result

PATIENT ID: T0000 Flag Age: 00 Reference Range

Account

Unit

#: 0of Measure

Creatinine 100 >=20 mg/dL

Declared Medications

DATE OF BIRTH

00/00/0000

PATIENT

GENDER

F

DATE OF SERVICE

0/0/0000

PHYSICIAN

DOCTOR, TEST

Account #: 0

ACCESSION NUMBER: S0000000 REQUISITION NUMBER: S0000000

RECEIVED: 0/0/0000 00:00 PM Report Status: FINAL

Creatinine 100

AMPHETAMINES

MUSCLE RELAXANTS

Methamphetamine

Not Detected TAPENTADOL

++POSITIVE++ Baclofen

Not Detected Quetiapine

The flagging and interpretation on this report are based on the following declared medications. Unexpected results may arise from

Amphetamine

Not Detected Tapentadol 300 Carisoprodol

Not Detected Risperidone

inaccuracies in the declared medications.

MDMA (Ecstasy)

Not Detected OTHER OPIOIDS

NEGATIVE Meprobamate

Not Detected Fluphenazine

MDA (Ecstasy metabolite)

BENZODIAZEPINES

NEGATIVE

Not Detected

NEGATIVE

Alfentanil

Naltrexone

Nalbuphine

Not Detected

Not Detected

Not Detected

Cyclobenzaprine

Desmethylcyclobenzaprine

NEGATIVE

Not Detected

Not Detected

The testing scope of this panel includes these Alprazolam

Diazepam

Not Detected

(Xanax) 05/25/2019Butorphanol

Not Detected Tizanidine

Not Detected Molindone

Not Detected

Desmethyldiazepam

Not Detected Meperidine

Not Detected Metaxalone

Not Detected Pimozide

Not Detected

medications:

Duloxetine

Oxazepam

Not Detected

(Cymbalta) 05/26/2019

Normeperidine

Not Detected Methocarbamol

Not Detected Prochlorperazine

Not Detected

Creatinine 100 Sufentanil Listed after Not the Detected specimen Lamotrigine test results.

Not

Temazepam

Not Detected Pentazocine

Not Detected Orphenadrine

Not Detected Thiothixene

Not Detected

Oxycodone

Alprazolam

Not Detected

05/26/2019

Propoxyphene

Not Detected SEDATIVE/HYPNOTICS

NEGATIVE Trifluoperazine

Not Alpha-hydroxyalprazolam Not Detected Norpropoxyphene AMPHETAMINES

Not Detected Zolpidem

Not Detected NEGATIVE

Ziprasidone

Not DetectedAlfentanil

Not Detected MUSCLE RELAXANTS

N

Desalkylflurazepam

Not Detected Tramadol

Not Detected Zolpidem Acid

Not Detected Perphenazine

Not Detected

Pregabalin (Lyrica) 05/25/2019

Lorazepam

Not Detected O-Desmethyltramadol

Not Detected Zopiclone/Eszopiclone

Not Detected Aripiprazole

Not Alpha-hydroxytriazolam

Not Detected N-Desmethyltramadol Methamphetamine

Not Detected Amino Chloropyridine

Not Detected

Not Detected

Asenapine

Not DetectedTAPENTADOL

++POSITIVE++

Technical Support Hotline

Baclofen

Not

Clonazepam

Not Detected SYMPATHOMIMETICS

NEGATIVE Zaleplon

Not Detected Iloperidone

Not Detected 5

7-aminoclonazepam

Not Detected Atomoxetine

Not Detected ANTIDEPRESSANTS

++POSITIVE++ Lurasidone

Not Detected

Amphetamine

Not Detected Tapentadol 300 Carisoprodol

Not

Midazolam

Not Detected Diethylpropion

Not Detected Amitriptyline

Not Detected ANALGESICS/NSAIDS

NEGATIVE

6

Toll-free telephone number that provides

Alpha-hydroxymidazolam Not Detected MDEA

Not Detected Amoxapine

Not Detected Acetaminophen

Not Flunitrazepam

Not Detected Ephedrine/Pseudoephedrine MDMA (Ecstasy)

Not Detected 8-Hydroxyamoxapine

Not Detected Not Diclofenac Detected Not DetectedOTHER OPIOIDS

NEGATIVE Meprobamate

Not

Desmethylflunitrazepam Not Detected Methylphenidate

Not Detected Bupropion

Not Detected Salicylate

Not Detected

Notes: Comments regarding potential

direct access to technical staff.

COCAINE & METABOLITE

NEGATIVE Ritalinic Acid

Not Hydroxybupropion

Not Detected Ibuprofen

Not Cocaine

Not Detected Phenmetrazine MDA (Ecstasy Not Detectedmetabolite)

Citalopram

Not Detected Not Ketoprofen Detected Not DetectedNaltrexone

Not Detected Cyclobenzaprine

Not

sources of a drug compound and

Benzoylecgonine

Not Detected Phentermine

Not Detected Desmethylcitalopram

Not Detected Naproxen

Not Detected

Cocaethylene

Not Detected Phenylpropanolamine

Not Detected Clomipramine

Not Detected Oxaprozin

Not Detected

metabolic pathways may be included.

BENZODIAZEPINES

NEGATIVE Nalbuphine

Not Detected Desmethylcyclobenzaprine Not

ALCOHOL, ETHYL

NEGATIVE Methcathinone

Not Detected Desmethylclomipramine Not Detected ANTIHISTAMINES

NEGATIVE

Alcohol, Ethyl

Not Detected BARBITURATES

NEGATIVE Desipramine

Not Detected Brompheniramine

Not Detected

CANNABINOIDS

++POSITIVE++ Amobarbital

Not Detected Doxepin

Not Detected Chlorpheniramine

Not Detected

Creatinine is used to normalize the

Diazepam

Not Detected Butorphanol

Not Detected Tizanidine

Not

Carboxy-THC 25 Barbital

Not Detected Desmethyldoxepin

Not Detected Diphenhydramine

Not Detected

6-ACETYLMORPHINE

NEGATIVE Butabarbital

Not Detected Duloxetine

PRESENT Doxylamine

Not drug concentration results.

6-acetylmorphine

Not Detected Butalbital Desmethyldiazepam

Not Detected Fluoxetine

Not Detected Not Hydroxyzine Detected Not DetectedMeperidine

Page 2: Report Not Detected Detail Metaxalone

Not

OPIATE CLASS

NEGATIVE Mephobarbital

Not Detected Norfluoxetine

Not Detected Promethazine

Not Detected

Codeine

Not Detected Pentobarbital

Not Detected Fluvoxamine

Not Detected Pyrilamine

Not Morphine

Not Detected Phenobarbital Oxazepam

Not Detected

Not Detected Imipramine

Not Detected Triprolidine

Not DetectedNormeperidine

Not Detected Methocarbamol

Not

Normorphine

Not Detected Secobarbital

Not Detected Mirtazapine

Not Detected LOCAL ANESTHETICS

NEGATIVE

Norcodeine

Not Detected Thiopental

Not Detected Nortriptyline

Not Detected Bupivacaine

Not Detected

Temazepam

Not Detected Pentazocine

Hydrocodone

Not Detected OTHER HALLUCINOGENS

NEGATIVE Paroxetine

Not Detected Lidocaine

Not Detected

Toxicology

Not Detected

Report Detail Orphenadrine

Not

6

Hydromorphone

Not Detected Ketamine

Detected Protriptyline

Not Detected Mepivacaine

Not Dihydrocodeine

Not Detected Norketamine AlprazolamNot Detected Sertraline

Not Detected Not Procaine Detected Not DetectedPropoxyphene

Not Detected

Drug-test results should be interpreted in the context of Norhydrocodone clinical information. Not Detected Phencyclidine Patient pharmacokinetic Not Detected Desmethylsertraline variables, Not specific Detected MISCELLANEOUS drug chemistry, NEGATIVE

Provides the result of each

SEDATIVE/HYPNOTICS

N

compound/

OXYCODONE CLASS

++POSITIVE++ ANTICONVULSANTS

++POSITIVE++ Maprotiline

Not Detected Atenolol

Not and specimen characteristics can affect test outcomes. Oxycodone Technical consultation 1000 Carbamazepine Alpha-hydroxyalprazolam

is available Not to Detected the health Nefazodone care provider Not Detected Not if Benztropine a Detected test result isNot DetectedNorpropoxyphene

Not Detected Zolpidem

Not

Oxymorphone 200 Clobazam

Not Detected Trazodone

Not Detected Caffeine

Not Detected

drug included in the test, including

inconsistent with an expected outcome. Call toll free 1-866-593-0157.

Noroxycodone 1000 Ezogabine

Not Detected 1,3 chlorophenyl piperazine Not Detected Clonidine

Not Detected

Desalkylflurazepam

Not Detected Tramadol

Not Detected Zolpidem Acid

Not

Noroxymorphone 100 Gabapentin

Not Detected Trimipramine

Not Detected Dextromethorphan

Not Detected

METHADONE

NEGATIVE Pregabalin

PRESENT Venlafaxine

Not Detected Dextrorphan/Levorphanol Not Detected

Expected and Unexpected findings.

Methadone

Not Detected Levetiracetam LorazepamNot Detected Desmethylvenlafaxine

Not Detected Diltiazem

Not Detected

EDDP (Methadone Mtb)

Not Detected Oxcarbazepine MHD

Not Detected Vilazodone

Version: 7.9.9.2686 Not Detected O-Desmethyltramadol

Not Detected Zopiclone/Eszopiclone

Not

Not Detected Guaifenesin

Not Detected

BUPRENORPHINE

NEGATIVE Primidone

Not Detected ANTIPSYCHOTICS

NEGATIVE Metoprolol

Not Buprenorphine

Not Detected Rufinamide Alpha-hydroxytriazolam

Not Detected Chlorpromazine Reported: 00/00/0000 Not Detected Not Milnacipran Detected 00:00 PM Not DetectedN-Desmethyltramadol

Not Detected Amino Chloropyridine

Not

Norbuprenorphine

Not Detected Tiagabine

Not Detected Clozapine

Not Propranolol

Not Detected

FENTANYL & ANALOGUES

NEGATIVE Topiramate

Not Detected Desmethylclozapine Page: 1 of Not 3Detected

Theophylline

Not Fentanyl

Not Detected Phenytoin

Clonazepam

Not Detected

Not Detected Loxapine

Not Detected Verapamil

Not DetectedSYMPATHOMIMETICS

7 Level of Detection

NEGATIVE Zaleplon

Not

Norfentanyl

Not Detected Zonisamide

Not Detected 8-Hydroxyloxapine

Not Detected

7-aminoclonazepam

Not Detected Atomoxetine

Present and Declared Present and Not Declared Absent but Declared Drugs Present, No Medication List Provided

Section listed Not Detected after the Toxicology ANTIDEPRESSANTS Report

++P

LEVEL OF DETECTION Midazolam

Not Detected Diethylpropion Detail and Not includes Detectedthe levels Amitriptyline of detection

Not

The drugs included in this screen are listed in the table above. The testing thresholds, if included in the table, are as follows: AMPHETAMINES: 50 ng/mL; BENZODIAZEPINES: 20 ng/mL; COCAINE & METABOLITE: 50

7 ng/mL; ALCOHOL, ETHYL: 0.020 gm/dL; ETHANOL BIOMARKERS: Alpha-hydroxymidazolam

ETG-500 ng/mL, ETS-250 ng/mL; CANNABINOIDS: total-20 ng/mL, carboxy-THC-2 ng/mL; 6-ACETYLMORPHINE: Not Detected

10 ng/mL; OPIATE CLASS: 50 ng/mL; MDEA

OXYCODONE CLASS: 50 ng/mL; METHADONE: 50 ng/mL; BUPRENORPHINE: buprenorphine-1.0 ng/mL, norbuprenorphine-5 ng/mL; OPIATE ANTAGONIST: 50 ng/mL; FENTANYL & ANALOGUES: fentanyl-1.0 ng/mL,

for each compound

Not Detected

that was Amoxapine analyzed in

Not

others-5 ng/mL; TAPENTADOL: 50 ng/mL; OTHER OPIOIDS: 50 or 150 ng/mL; SYMPATHOMIMETICS: 100 or 300 ng/mL; BARBITURATES: 200 ng/mL; OTHER HALLUCINOGENS: ketamine-300 ng/mL, PCP-25 ng/mL;

ANTICONVULSANTS: 50, 300, or 1000 ng/mL; MUSCLE RELAXANTS: 50 or 300 ng/mL; SEDATIVE/HYPNOTICS: zaleplon, zolpidem-5 ng/mL, zopiclone/eszopiclone-50 ng/mL; ANTIDEPRESSANTS: 50 or 100 ng/mL;

ANTIPSYCHOTICS: 10, 50 or 100 ng/mL; ANALGESICS/NSAIDS: salicylate-3 Flunitrazepam

mg/dL, others-0.5 or 1.0 µg/mL; ANTIHISTAMINES: 50 or 100 ng/mL; LOCAL ANESTHETICS:

Not

100

Detected

ng/mL; MISCELLANEOUS: caffeine (large Ephedrine/Pseudoephedrine Not Detected 8-Hydroxyamoxapine

Not

amounts)- 1.0 µg/mL, others-50, 100 or 300 ng/mL; NICOTINE METABOLITE: 200 ng/mL.

the profile.

This test was developed and its performance characteristics Desmethylflunitrazepam

determined by LabCorp. It has not been cleared or approved by the Food and Not Drug Administration. Detected Methylphenidate

Not Detected Bupropion

Not

PERFORMING LABS

MEDTOX LABORATORIES 402 WEST

COCAINE

COUNTY ROAD D, ST PAUL,

& METABOLITE

NEGATIVE

MN 55112 Lab: (877) 474-5767 Dir. Karla J Walker, Pharm.D.

Ritalinic Acid

Not Detected Hydroxybupropion

Not

For Inquiries, the physician may contact the lab using the numbers indicated above.

This document contains private and confidential health information Cocaine protected by state and federal law. If you have received this document Not in error, Detected

please call 877-474-5767. Phenmetrazine

Not Detected Citalopram

Not

Version: 7.9.9.2686

Benzoylecgonine

Page 3: Cumulative Report Section

Reported: Not Detected

00/00/0000 00:00 PM Phentermine

Not Detected Desmethylcitalopram

Not

Page: 2 of 3

Cocaethylene

Not Detected Phenylpropanolamine

Not Detected Clomipramine

Not

ALCOHOL, ETHYL

NEGATIVE Methcathinone Toxicology

Not Detected

Cumulative Desmethylclomipramine

Report

Not

8

Alcohol, Ethyl

Not Detected BARBITURATES

NEGATIVE

Provides a summary of previous

Desipramine

Not

results for

CANNABINOIDS

++POSITIVE++ Amobarbital

Not Detected Doxepin

Not

the same patient and is listed on the last

Carboxy-THC 25 Barbital

Not Detected Desmethyldoxepin

Not

page of the ToxAssure report.

6-ACETYLMORPHINE

NEGATIVE Butabarbital

Not Detected Duloxetine

PR

6-acetylmorphine

Not Detected Butalbital

Not Detected Fluoxetine

Not

OPIATE CLASS

NEGATIVE Mephobarbital

Not Detected Norfluoxetine

Not

Codeine

Not Detected Pentobarbital

Not Detected Fluvoxamine

Not

Morphine

Not Detected Phenobarbital

Not Detected Imipramine

Not

Normorphine

Not Detected Secobarbital

Not Detected Mirtazapine

Not

Norcodeine

Not Detected Thiopental

Not Detected Nortriptyline

Not

Hydrocodone

Not Detected OTHER HALLUCINOGENS

NEGATIVE Paroxetine

Not

Hydromorphone

Not Detected Ketamine For more information, or Not to Detected set up a testing Protriptyline program,

Not

Dihydrocodeine

Not contact Detected us at Norketamine 877-474-5767, or MedWatchMTX@Labcorp.com.

Not Detected Sertraline

Not

Norhydrocodone

Not Detected Phencyclidine

Not Detected Desmethylsertraline

Not

OXYCODONE CLASS

++POSITIVE++ ©2021 Laboratory

ANTICONVULSANTS

Corporation of America® Holdings ++POSITIVE++ All rights reserved.

Maprotiline

L13216-0821-10

Not

Oxycodone 1000 Carbamazepine

Not Detected Nefazodone

Not

Oxymorphone 200 Clobazam

Not Detected Trazodone

Not

Noroxycodone 1000 Ezogabine

Not Detected 1,3 chlorophenyl piperazine Not

Noroxymorphone 100 Gabapentin

Not Detected Trimipramine

Not

Olanzapine

Haloperidol

Thioridazine

Not Detected

Not Detected

Not Detected

Not Detected

Not Detected

Not Detected

1

2

Drugs Present and Declared

for Prescription Verification

Present and Declared

These findings are expected; any

positive drug screen results listed in this

section correspond with the declared

medications.

Drugs Present but Not Declared for

Prescription Verification

Present and Not Declared

These findings are unexpected; none of

the positive drug screen results listed in

this section would be produced by the

declared medications.

Drugs Absent but Declared for

3

Prescription Verification

FOR PATIENT

PRESCRIPTION VERIFICATION

DATE OF BIRTH

GENDER DATE OF SERVICE

TEST, EXAMPLE

00/00/0000 Absent but Declared F 0/0/0000

These findings are unexpected; the

DATE OF BIRTH

GENDER DATE OF SERVICE PHYSICIAN

results for a declared medication are “Not

Detected” although regularly scheduled

ACCESSION NUMBER: S0000000 REQUISITION NUMBER: use of the S0000000 declared medication is RECEIVED: 0/0/000

TOXICOLOGY REPORT DETAIL

Drug brands, if listed herein, are trademarks of their respective owners.

Sufentanil

Not Detected Lamotrigine

Not Detected Mesoridazine

Not Detected

expected to produce a positive result.

4

TOXICOLOGY REPORT DETAIL

Declared Medications


ToxAssure® Flex

Test Portfolio

Flexible drug test options for answers you can trust


ToxAssure® Flex

Test Portfolio

Choosing Appropriate Testing

Drug testing plays a critical role in monitoring patients who are prescribed

controlled substances, and there are many factors to consider when choosing a

test. Two considerations include designating which drugs to screen and selecting

the appropriate testing methodology. Evaluating the patient history, risk factors,

prescribed medications, potential interactions, previous results, and other clinical

concerns can help in selecting which drugs to test. When choosing a methodology,

providers must weigh the strengths and limitations of each while also considering

medical necessity and cost.

Toxicology is a complex

science, and we know that

choosing the right drug

test can be challenging.

ToxAssure Flex Portfolio

Labcorp offers test options for over 200 drug compounds. When possible, our menu

includes presumptive, presumptive with reflex to definitive, and definitive testing.

The ToxAssure Flex portfolio allows you to choose individual drug classes by mixed

methodologies as single tests, or along with other tests as part of a panel. Results will

be returned in a consolidated ToxAssure report with interpretative comments that

include methodology-specific considerations. Additionally, individual drug classes

by definitive testing can help complement point-of-care or other presumptive tests

performed in office.

Drug Classes Available for Testing

Opiates/opioids

Cocaine

Buprenorphine

Phencyclidine

Fentanyl

THC (Cannabinoids)

Heroin metabolite (6-am)

Analgesics/NSAIDS

Opiates

Anticonvulsants

Oxycodone Gabapentin only

Meperidine Pregabalin only

Methadone

Antidepressants

Propoxyphene

Antihistamines

Tapentadol

Antipychotics

Tramadol

Dextromethorphan

Other

Ketamine

Alcohol, ethyl

Methylphenidate

Ethanol biomarkers (EtG/EtS)

Skeletal Muscle Relaxants

Amphetamines Carisoprodol only

Barbiturates

Sedative/Hypnotics, non-benzo

Benzodiazepines

Sympathomimetics

Additional test options available. Please contact your Labcorp sales representative for assistance.

ToxAssure Flex Panels

In addition to tests for individual drugs and drug classes, we

also offer panel options. Labcorp’s ToxAssure Flex panels

employ the most appropriate methodology for each drug

class given the technical performance and the clinical utility

of testing. This approach provides a cost-effective way to

achieve reliable results for each patient.

• Presumptive-only testing is utilized for compounds that

are very reliable on immunoassays such as ethyl alcohol

and acetaminophen.

• Presumptive with reflex to definitive testing is utilized

for most drug classes to help confirm immunoassay

results and rule out false positives from cross reactive

compounds.

• Definitive-only testing is utilized for drug classes where

the immunoassay is not reliable for some compounds,

the detection threshold of the immunoassay is not

acceptable for prescribed dosages, or immunoassay

testing does not routinely exist for the compound(s).

Drug Class

Reason for methodology choice

Benzodiazepines

Clonazepam and lorazepam not reliable on immunoassay

Buprenorphine

Prescribed in low dosages for pain that may not be detectable with

immunoassay thresholds

Fentanyl

Prescribed in low dosages for pain that may not be detectable with

immunoassay thresholds

Other Hallucinogens

Sedative/hypnotics

Dextromethorphan dextrorphan/

levorphanol

Drug classes not routinely available on immunoassay

Drug Classes

Included in

ToxAssure Flex 15,

Urine Test No. 912334

Included in

ToxAssure Flex 23,

Urine Test No. 912335

Alcohol, Ethyl* • • ethyl alcohol

Drug Metabolites Included

Ethanol biomarkers • ethyl glucuronide (EtG), ethyl sulfate (EtS)

6-Acetylmorphine* • • 6-acetylmorphine

Amphetamines* • •

Barbiturates • •

Benzodiazepines* • •

methamphetamine, amphetamine, methylenedioxymethamphetamine

(MDMA), methylenedioxyamphetamine (MDA)

amobarbital, barbital, butabarbital, butalbital, mephobarbital,

pentobarbital, phenobarbital, secobarbital, thiopental

Buprenorphine* • • buprenorphine, norbuprenorphine

Cannabinoids (THC)* • • total metabolites

alprazolam, alpha-hydroxyalprazolam, chlordiazepoxide (as

metabolites desmethyldiazepam and oxazepam), clonazepam,

7-aminoclonazepam, clorazepate (as metabolites desmethyldiazepam

and oxazepam), desalkylflurazepam, diazepam, desmethyldiazepam,

flunitrazepam, desmethylflunitrazepam, lorazepam, midazolam, alpha

hydroxymidazolam, oxazepam, temazepam, alpha-hydroxytriazolam

Cocaine & Metabolite* • • cocaine, benzoylecgonine, cocaethylene

Fentanyl & Analogues* • • fentanyl, norfentanyl, sufentanil, alfentanil

Methadone* • • methadone, EDDP (methadone metabolite)

Opiate Class* • •

codeine, norcodeine, dihydrocodeine, hydrocodone, norhydrocodone,

hydromorphone, morphine, normorphine

Oxycodone Class* • • oxycodone, oxymorphone, noroxycodone, noroxymorphone

Tapentadol* • • tapentadol

Tramadol* • • tramadol, o-desmethyltramadol, n-desmethyltramadol

Other Opioids • meperidine, normeperidine, propoxyphene, norpropoxyphene

Analgesics/NSAIDS • acetaminophen

Anticonvulsants • gabapentin

Muscle Relaxants • carisoprodol, meprobamate

Other Hallucinogens • ketamine, norketamine, phencyclidine (PCP)

Sedative/ Hypnotics •

zaleplon, zolpidem, zolpidem acid, zopiclone/eszopiclone, amino

chloropyridine (zopiclone/eszopiclone breakdown product)

Additional

Miscellaneous

Compounds

*Denotes drug classes that are reported quantitatively

• dextromethorphan, dextrorphan/levorphanol

When you need access to toxicology experts, we are ready to provide answers.

Physician Reference Phone Line: (866) 593-0157

For more information, or to set up a testing program,

contact us at 877-474-5767, or MedWatchMTX@Labcorp.com.


DEFINITIVE TESTING RESOURCE FOR MEDICATION-ASSISTED TREATMENT GUIDE

This resource is intended to assist with evaluating specimens where point of care

or presumptive analyzer testing is performed in the physician office.

If the patient history and/or presumptive screen results indicate that definitive testing may be appropriate, the Labcorp test number listed below may be

requested on a Labcorp test request form. Refer to the back for an example of the Labcorp test request form. Please note: A completed Labcorp test request

form is required for ordering any laboratory testing. This is not a complete list of tests and additional testing options can be found at Labcorp.com. Test

numbers indicated on this form are designed specifically for monitoring patients who are on Suboxone/buprenorphine only. This testing should not be used

for monitoring chronic pain patients (medical drug monitoring) or methadone medication assisted treatment.

Patient Name: __________________________________________________________________________ Patient Visit Date:________________________

Drug Class

Amphetamines/

Methamphetamine

Step 1:

Prescribed and/or Self-reported Drugs

Mark appropriate Drug Name for prescribed or

identified drugs based on the patient history

and/or self-reporting.

Drug Name

□ Amphetamine (Adderall, Vyvanse)

□ MDA

□ MDMA

□ Methamphetamine

Barbiturates □ Butalbital (Fiorinal) □ Thiopental

□ Phenobarbital □ Other: _______________

Benzodiazepines

□ Alprazolam (Xanax) □ Flurazepam (Dalmane)

□ Chlordiazepoxide (Librium) □ Midazolam (Versed)

□ Clonazepam* (Klonopin) □ Oxazepam (Serax)

□ Clorazepate (Tranxene) □ Temazepam (Restoril)

□ Diazepam (Valium) □ Triazolam (Halcion)

Step 2:

Presumptive Screen Results

Mark Positive or Negative, if applicable. Compare Step 1

and Step 2 to determine appropriate outcome for each

drug class (refer to Additional Considerations column and

Table 1 below for details).

Positive

(+)

□

Negative

(-)

□

Additional Considerations

†Non-detectable in screen:

Methylphenidate 1

‡Potential of false positive: Bupropion 2 ,

Ephedrine 1 , Pseudoephedrine 2 ,

Trazodone 2 , Phentermine 1

Step 3:

Definitive Testing (as appropriate)

Definitive testing may be indicated if Step 1 and

Step 2 have an outcome of unexpected positive

or unexpected negative, or expected positive and

identification of a specific drug within the class is

desired. Mark the appropriate definitive test that

should be ordered on the Labcorp Test Request Form.

Test No. / Test Name

(Requires 10mL urine per test if

ordering 2 or more tests)

701734 Amphetamine Confirmation

□ □ †Non-detectable in screen: Phenytoin 1 701732 Barbiturate Confirmation

□

□

†

Non-detectable in screen: Lorazepam 3

*

Limited detection in screen:

Clonazepam 4

Labcorp confirmation assay includes

detection of these drugs.

701735 Benzodiazepine and Metabolite Confirmation

Buprenorphine □ Buprenorphine (Butrans, Suboxone, Subutex) □ □ 701279 Buprenorphine Confirmation and naloxone

Cocaine □ Cocaine □ □ 701739 Cocaine Metabolite Confirmation

Methadone □ Methadone (Dolophine, Methadose) □ □

Opiates

Oxycodone/

Oxymorphone

□ Codeine

□ Dihydrocodeine

□ Heroin

□ Hydrocodone (Vicodin, Lortab, Lorcet )

□ Hydromorphone (Dilaudid)

□ Morphine (Roxanol, Kadian)

□ Oxycodone (Percocet, OxyContin)

□ Oxymorphone (Opana)

Phencyclidine

(PCP) □ Phencyclidine (PCP) □ □

□

□

□

□

‡Potential of false positive:

Tapentadol 5 , Tramadol 6

‡Potential of false positive: Oxycodone

(Oxycodone is an opiate drug that

has poor to little cross-reactivity with

opiate drug class immunoassays.

However, large amounts of oxycodone

may result in positive results for some

opiate class immunoassays.)


Hydrocodone 1


Dextromethorphan 2 ,

Diphenhydramine 2 , Sertraline 5 ,

Venlafaxine 2 , Ketamine 2

701738 Methadone Confirmation

701742 Opiates Confirmation

701745 Oxycodone/Oxymorphone Confirmation

701743 Phencyclidine Confirmation

Propoxyphene □ Propoxyphene (Darvon, Darvocet) □ □ 701746 Propoxyphene Confirmation

THC

(Cannabinoids) □ Marijuana/THC □ □

†Non-detectable in screen:

Synthetic cannabinoids (K2/Spice) 1


Pantoprazole 2

†Drugs not detected in presumptive screen assays. Additional Labcorp test options are available to detect these drugs (refer to back for examples).

*Drugs with limited detection in presumptive screen assays. Additional Labcorp test options are available to detect these drugs (refer to back for examples).

‡Drugs in other classes that may cause false positive presumptive screen results.

701747 Cannabinoid Confirmation

Table 1

Prescribed and/or

Self-reported Drug

Presumptive

Screen Results

Outcome

Definitive Testing

None checked Positive Unexpected Positive Screen Definitive testing may be indicated if confirmation is desired.

One or more checked Positive Expected Positive Screen Definitive testing may be indicated if identification of a specific drug within the class is desired.

One or more checked Negative Unexpected Negative Screen

Definitive testing may be indicated to demonstrate the presence of a specific expected drug within

the class that is not reliably detectable in the screen (see Additional Considerations above).

None checked Negative Expected Negative Screen Definitive testing is not indicated.

This is not a test order form.

Drugs not commonly screened in physician office setting

Drug Name

Prescribed and/or

Admitted Drugs

Test No.

Definitive Testing

Alcohol Metabolites (EtG/EtS) □ Alcohol 701737

Carisoprodol/Meprobamate □ Carisoprodol 701736

Fentanyl □ Fentanyl 701740

Heroin Metabolite (6-AM) □ Heroin 701731

Tapentadol □ Tapentadol 701744

Tramadol □ Tramadol 701781

Medicare or Medicaid Reimbursement: Please remember that (1) when

ordering tests for which Medicare or Medicaid reimbursement is sought, the

physician should only order those tests that the physician believes are medically

necessary for each patient, (2) that using a customized profile may result in

ordering tests for which Medicare or Medicaid will deny payment, (3) that the

physician should order individual tests or a less inclusive profile where not all

the tests in the customized test combination/profile are medically necessary for

an individual patient, and (4) that the United States Department of Health and

Human Services, Office of Inspector General, takes the position that a physician

who orders medically unnecessary tests may be subject to civil penalties.

R

E

Q

U

E

S

T

E

D

B

1A

Y

LabCorp Medication Assisted Treatment Testing

LabCorp Medication Assisted Treatment Testing

2210.03

8810166357

2210.03

8810166357

1A

nearest patient service center, 1C visit

rp.com or call 888- LABCORP

677). Medical drug monitoring

rop off will not be accepted.

rug Class

mine / Methamphetamine

ates

azepines

rphine

metabolite

ne

ne

encyclidine)

hene

nnabinoids)

odol / Meprobamate

etabolite (6-Acetylmorphine)

ne

l

ol

(888-522-2677). Medical drug monitoring

specimen drop off will not be accepted.

Example: Labcorp Test Request Form

Patient’s Legal Name (Last, First, MI)

Physician’s Name (Last, First) Sex Date of Birth

Physician/Authorized Collection Time Fasting

SignatureCollection Patient’s Date

Address Urine hrs/vol

Phone

MO DAY YR

AM Yes MO DAY YR

REQUIRED R E Q U I R E D

X :

PM No

hrs vol

1C

Diagnosis/Signs/Symptoms in ICD-CM format in effect at Date of Service

City

State

ZIP

NPI

Physician’s ID # Patient’s ID #

Hospital Patient Status:

Highest Specificity Required

In-Patient Out-Patient Non-Patient

Name of Policy Holder (if different from patient)

Physician’s Name (Last, First)

Physician/Authorized Signature Patient’s Address

Phone

P

X

PRIMARY BILLING PARTY

SECONDARY BILLING PARTY

Address of Policy Holder L

APT #

Diagnosis/Signs/Symptoms in ICD-CM format in effect at Date of Service

City

State

ZIP

Insurance Carrier *

Insurance Carrier *

E

Highest Specificity Required

A

Name of Policy Holder (if different from patient)

City

State

ZIP

ID #

ID #

S

E

PRIMARY BILLING PARTY

SECONDARY BILLING PARTY

Address of Policy Holder

I hereby authorize the release APT of medical #

information related to the service described herein and authorize payment directly to LabCorp.

I agree to assume responsibility for payment of charges for laboratory services that are not covered by my healthcare insurer.

Group #

Group #

Insurance Carrier *

Insurance Carrier *

P

City

X State

ZIP

R

ID #

Insurance ID #

Address

Insurance Address

Patient’s Signature

Date

I

I hereby authorize the release of medical information related to the service described MEDICARE herein and authorize ADVANCE payment directly to BENEFICIARY LabCorp.

NOTICE OF NON-COVERAGE (ABN)

I agree to assume responsibility for payment of charges for laboratory services that are not covered by my healthcare insurer.

Group #

Name Group of #

Insured Person

Name of Insured Person

N

Refer to policies published by your Medicare T

Administrative Contractor (MAC), CMS,

X

or www.LabCorp.com/MedicareMedicalNecessity when ordering tests that are subject

Insurance Address

Relationship Insurance Address

to Patient

Patient’s Relationship Signature

to Patient

Date

to ABN guidelines.

MEDICARE ADVANCE BENEFICIARY NOTICE OF NON-COVERAGE (ABN)

Name of Insured Person

Employer Name of Insured Name

Person

Employer Name

Clinical Information/Comments

Refer to policies published by your Medicare Administrative Contractor (MAC), CMS,

or www.LabCorp.com/MedicareMedicalNecessity when ordering tests that are subject

Relationship to Patient

*If Relationship Medicaid to State Patient

Physician’s Provider #

Workers Comp

to ABN guidelines.

Yes

No

Employer Name

*If Medicaid State Physician’s Provider #

701385 Buprenorphine MAT Screen Only, Urine

(80307)

Drug Class

rofile is selected above, do not request

drugs that are included in the profile

test order:

Employer Name

Note: If a profile is selected above, do not request

individual drugs Laboratory that are included Test in the Order profile(Urine)

Amphetamine (choose / only Methamphetamine

one test per Drug Class)

Barbiturates Screen*

Screen*, reflex

only

Confirmation

Benzodiazepines

701860

737691

Buprenorphine 701863

737695

Cocaine 701865**

metabolite 763900**

701861 701735

Methadone 761160

763400

701874 701279

Opiates 701861

737750

701864 701739

Oxycodone 701874

737026

701866 701738

PCP (Phencyclidine)

701864

737856

701871 701742

Propoxyphene 701866

763896

701872 701745

THC (Cannabinoids)

701871

737760

701869 701743

Carisoprodol

701872

/ Meprobamate

737477

761107 701746

701869

737738

701747

Fentanyl

761200

761107

764032

701736

Heroin metabolite (6-Acetylmorphine)

701875

761200

764200

701740

Meperidine

733738

701875

737933

701731

Tapentadol

701900

733738

761060

761050

Tramadol

701900

764170

733740 701744

733740

761018

701781

Other test order:

*Note: If an in-office screen was performed and billed

n in-office screen was performed and by billed

the physician/practice, an order for screening by

ysician/practice, an order for screening LabCorp/MedTox by

may result in a duplicate service

MedTox may result in a duplicate service

** Screen (immunoassay) does not routinely

(immunoassay) does not routinely

detect Clonazepam or Lorazepam

lonazepam or Lorazepam

Patient’s Legal Name (Last, First, MI)

Sex

Date of Birth

MO

DAY

YR

REQUIRED R E Q U I R E D

Workers Comp

Yes No

PATIENT

RESP. PARTY

Profile Options – choose only one (see reverse for test component details)

P

(Additional profile options are available – contact your LabCorp representative)

L

E

701486 Buprenorphine MAT Monitoring 1, Urine

701985 Buprenorphine A

MAT Monitoring 2, Urine

(80307; addtl. 80348 & 80362 if reflex to confirm)

(80307; S

addtl. CPT if reflex to confirm)

E

701486 Buprenorphine Laboratory

MAT Test

Monitoring Order

1, (Urine)

701985 Buprenorphine MAT Monitoring 2, Urine

(80307; (choose addtl. 80348 only & 80362 one if reflex test to per confirm)

Drug Class)

(80307; addtl. General CPT if reflex Health to confirm)

Testing (CPT codes P

in parentheses)

Screen*

Screen*, reflex

Confirmation

005009

CBC w Diff. w Platelet

R

(85025)

LAV

only

Confirmation

only

General Health Testing (CPT codes in parentheses)

I

701860

737691

701734

322755

Hepatic Function Panel (7)

(80076)

GEL

N

Confirmation

701863 005009

737695 CBC w Diff. w Platelet

701732

303756

Lipid Panel (85025) LAV

only

T

(80061)

GEL

701865**

701734 322755

763900** Hepatic Function Panel 701735 (7)

322758

Metabolic Panel, Basic (80076) GEL

(80048)

GEL

761160 701732 303756

763400 Lipid Panel

701279

004036

(80061) GEL

URN

Pregnancy Test, Urine

(81025)

701385 Buprenorphine Profile Options MAT – choose Screen only Only, one Urine (see reverse for test component details)

(Additional profile (80307) options are available – contact your LabCorp representative)

322758

737750

Metabolic Panel, Basic

701739

737026

701738

004036 Pregnancy Test, Urine

737856

701742

003038 Urinalysis

763896

701745

037215

737760 Hepatitis B Virus Evaluation 701743Profile

144050

737477 HCV Ab w/Rflx to Quant. 701746 RT-PCR

322744

737738 Acute Hepatitis Profile 701747 (A/B/C)

165180

764032 HSV 1/2 Abs, IgM, Indirect

701736

083935

764200 HIV1/O/2 4th Gen. with 701740 reflex

737933

012005 RPR, Rfx Qn RPR/Confirm 701731

TP

761060

761050

004515 Estradiol

764170

701744

001453

761018

Hemoglobin (Hgb) A1c

701781

182879 QuantiFERON ® -TB Gold Plus

004226

004259

081950

Clinical Information/Comments

Testosterone, Total

TSH, 3rd generation

Vitamin D, 25-Hydroxy

Drug brands listed herein are trademarks of their respective owners.

Urinalysis (80048) GEL

URN

(81025) Cup

Hepatitis B Virus Evaluation Profile

UA

(81003) Trnspt

HCV Ab w/Rflx to Quant. RT-PCR

(86704, 86706, 87340) GEL

Acute Hepatitis Profile (A/B/C)

(86803) GEL

HSV 1/2 Abs, IgM, Indirect

(80074) GEL

HIV1/O/2 4th Gen. with reflex

(86695, 86696) GEL

RPR, Rfx Qn RPR/Confirm TP

(87389) GEL

Estradiol (86592) GEL

Hemoglobin (Hgb) A1c (82670) GEL

QuantiFERON ® -TB (83036)

Gold Plus LAV

Testosterone, Total(86480)

KIT

TSH, 3rd generation(84403)

Vitamin D, 25-Hydroxy (84443)

(82306) GEL

Drug brands listed herein are trademarks of their respective owners.

PATIENT NAME:__________________________

PATIENT NAME:__________________________

ere to remove LabCorp MedWatch Peel here ®

to remove LabCorp MedWatch ®

Label ➡

Label ➡

8810166357

8810166357 RR Donnelley ©2020. All rights reserved. — 0667

1B

ITEM # 123173 FORM # 2210

© 2020 Laboratory Corporation of America ® Holdings BBF

Printing Solutions

BURLINGTON, NC 27216

(REV 07/28/2020)

To find the nearest patient service center, visit

www. labcorp.com or call 888- LABCORP

NPI

Physician’s ID # Patient’s ID #

003038

037215

144050

322744

165180

083935

012005

004515

001453

182879

004226

004259

081950

Collection Time

ORIGINAL-LABORATORY / COPY-CLIENT

1A

1B

Hospital Patient Status:

DATE:_____/______/___________ DATE:_____/______/___________ LabCorp MedWatch ®

LabCorp MedWatch ®

PATIENT

RESP. PARTY

:

GEL

GEL

AM

PM

Fasting

Yes

No

Collection Date

MO DAY YR

hrs

Urine hrs/vol

vol

In-Patient Out-Patient Non-Patient

(81003)

(86704, 86706, 87340)

(86803)

(80074)

(86695, 86696)

(87389)

(86592)

(82670)

(83036)

(86480)

(84403)

(84443)

(82306)

Cup

UA

Trnspt

GEL

GEL

GEL

GEL

GEL

GEL

GEL

LAV

KIT

GEL

GEL

GEL

1. Complete patient demographics, including: patient name,

date of birth, gender, and specimen collection date.

P

L

E

A

S

E

P

R

I

N

T

2. Use the Labcorp Definitive Testing Resource Guide to select

the individual definitive testing option that is deemed

appropriate based on the point of care/presumptive screen

results (if applicable) and the patient’s prescribed and/or

admitted drug history and/or other clinical indications.

P

L

E

A

S

E

3. Example: Patient is prescribed lorazepam, but has an

P

R unexpected negative for benzodiazepines on the point of

I

N

care/presumptive screen. Since the presumptive screen

T

may have limited detection of lorazepam, testing for the

individual benzodiazepine and Metabolite Confirmation may

be requested.

ORIGINAL-LABORATORY / COPY-CLIENT

1B

1C

WHEN ORDERING TESTS FOR WHICH MEDICARE NOTE: WHEN OR MEDICAID ORDERING REIMBURSEMENT TESTS FOR WHICH WILL BE MEDICARE SOUGHT, OR PHYSICIANS MEDICAID SHOULD REIMBURSEMENT ONLY ORDER WILL TESTS BE THAT SOUGHT, ARE MEDICALLY PHYSICIANS NECESSARY SHOULD FOR ONLY THE ORDER DIAGNOSIS TESTS OR THAT TREATMENT ARE MEDICALLY OF THE PATIENT.

NECESSARY FOR THE DIAGNOSIS OR TREATMENT OF THE PATIENT.

References

1. ToxCup® Drug Screen Cup Step-by Step Instructions.

2. Standrige JB, et al. Urine drug screening: a valuable office procedure. Am Fam Physician. 2010;81(5):635-640. PubMed 20187600

3. Boggs, CL. CAP quality practices committee – Benzodiazepines: laboratory detection challenges. NewsPath. http://www.cap.org/apps/docs/newspath/1112/benzodiazepines.pdf, accessed Jan 15, 2016.

4. West R, et al. Comparison of clonazepam compliance by measurement of urinary concentration by immunoassay and LC-MS/MS in pain management population. Pain Physician. 2010;13(1):71-78. PubMed 20119465

5. Saitman A, et al. False-positive interferences of common urine drug screen immunoassays: a review. J Analyt Toxicol. 2014;38(7):387-396. PubMed 24986836

6. Internal laboratory data.

7. Moeller KE, et al. Urine drug screening: practical guide for clinicians. Mayo Clin Proc. 2008;83(1):66-76. PubMed 18174009

For addtional testing options, visit Labcorp.com

Drug brand names listed are examples of commonly prescribed medications and are not inclusive

of all available brands. Drug names listed are trademarks of their respective owners.


LabCorp

CBD/THC TESTING

NOW AVAILABLE THROUGH LABCORP

Cannabidiol (CBD)/Tetrahydrocannabinol (THC) Ratio, Urine

With the rise in the commercial availability and use of products

containing CBD 1,2 , health care providers are increasingly faced with the

challenge of determining if a positive marijuana drug test was caused

by use of a CBD product, or from use of marijuana, medical THC, or

other THC products. To assist our clients in differentiating CBD use from

marijuana use, LabCorp has developed a new assay measuring and

calculating a ratio of CBD and THC metabolites in urine.

Test Number: 701907, Cannabidiol (CBD)/Tetrahydrocannabinol (THC) Ratio, Urine

Specimen Type: Urine (random)

Methodology: Liquid chromatography/tandem mass spectrometry (LC/MS-MS)

Use: To assist in distinguishing whether a positive urine THC test is exclusively

the result of CBD use

Volume: 30 mL

Ordering: May be ordered in addition to a drug-test panel or separately.

Questions and Answers

What is CBD?

The cannabis plant contains more than eighty biologically active

compounds 3 and CBD is one of the plant’s main active ingredients. 2

CBD is also found in hemp plants, which have lower levels of

psychoactive THC than marijuana. Commercially available CBD

products that are not prescribed under medical marijuana laws must

be derived from hemp, containing less than 0.3% of THC by weight. 3

However, testing of CBD products is currently neither uniform nor

mandated. Thus, many CBD products are not free of THC and product

packaging may not accurately reflect the actual THC content. 4

Why order the CBD/THC ratio urine test?

In instances where a donor tests positive for marijuana (THC

metabolite present in urine), and the donor denies marijuana use

but claims using CBD, then the measurement and comparison of

CBD metabolites relative to THC metabolites may assist with

distinguishing if the source of THC in the urine sample could have

resulted from CBD use, or from surreptitious marijuana use.

How is the CBD/THC ratio calculated?

The LabCorp CBD/THC ratio test measures CBD and THC metabolites

in urine. The CBD/THC ratio is calculated using the sums of the

respective metabolites. The ratio assists in differentiating the presence

of THC metabolites due to either: the use of marijuana (medicinal or

clandestine), or the use of CBD or hemp products containing unknown

but presumably small amounts of THC. If the concentration of CBD

metabolites greatly exceeds that of THC metabolites, the calculated

metabolic ratio of a sample would indicate that the donor’s sample

appears consistent with the use of CBD products.

How will the LabCorp CBD/THC ratio test result be reported?

CBD/THC Ratio

Interpretation*

>=10.0 Consistent with the use of CBD products only

1.0 – 9.9 Indeterminant

<1.0 Consistent with use of either marijuana, THC products,

or mixed use

*Interpretive ranges are provided as guidance and should not be considered definitive. Interpretation

of results should include consideration of all relevant clinical and diagnostic information.

References

1. U.S. Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products

containing cannabis and cannabis-derived compounds. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agricultureimprovement-act-and-agencys.

Accessed August 19, 2019.

2. National Institute on Drug Abuse. Researching marijuana for therapeutic purposes: The potential promise of cannabidiol (CBD). https://www.drugabuse.gov/about-nida/norasblog/2015/07/researching-marijuana-therapeutic-purposes-potential-promise-cannabidiol-cbd.


3. U.S. Food and Drug Administration. FDA regulation of cannabis and cannabis-derived products: Questions and answers. http://www.fda.gov/news-events/public-health-focus/fdaregulation-cannabis-and-cannabis-derived-products-questions-and-answers.


4. Substance Abuse and Mental Health Services Administration. Use of marijuana oils or marijuana infused commercial products. https://www.samhsa.gov/sites/default/files/

workplace/07-cbd-memo-11-21-17-final-letterhead-signed.pdf. Accessed August 19, 2019.

If you have questions or would like additional information

regarding this test, please contact your LabCorp representative or

call our MDM support line at 877-474-5767.


October 2022

Dear Valued Client,

Labcorp strives to align test offerings with current guidelines and recommendations to support timely, cost-effective, quality

patient care. A panel of internal scientific and clinical experts, as well as external key opinion leaders, was convened to review

current clinical guidelines and recommendations to develop a testing profile to best support care of the pregnant patient and

fetus during the first prenatal visit. As a result, in March 2022, Labcorp launched a new guideline-driven pregnancy testing profile

intended to evaluate health status at the first prenatal visit.

Screening for infectious diseases and pregnancy-related conditions early in pregnancy leads to better outcomes for mothers

and newborns. Our new Pregnancy, Initial Screening Profile [144053] consists of laboratory tests aligned with current clinical

guidelines and recommendations and incorporates reflex testing to supporting timely, quality care during pregnancy. Several of

previously existing pregnancy profiles will be discontinued as they no longer align with current guidelines and recommendations

or are redundant to the new profile. The profiles identified for discontinuation will become nonorderable on December 23, 2022.

New pregnancy profile details*

Test No. Test Name Test Components

144053

Pregnancy, Initial

Screening Profile

• CBC with platelet count and differential 1 • Rubella IgG 1

• ABO grouping and Rh typing 1

• Antibody screen (ID and titer) 1

• Urinalysis with microscopic examination 1

• Urine culture with GBS 1

• HBsAg screen 1-8

• Syphilis RPR with reflex to RPR titer and T. pallidum

antibody 1,2,5,6

• HIV p24 antigen/antibody screen with reflex 1,2,5,6

• HCV antibody with reflex to quantitative RNA 1,2,5-8

• C. trachomatis and N. gonorrhoeae NAAT 1,2

* For additional information, specimen requirements, and CPT codes please refer to our online Test Menu at www.labcorp.com.

Tests to be discontinued effective December 23, 2022

Test No.

231950 Obstetric Panel With Fourth-generation HIV

030387 Prenatal Profile I Without Hepatitis B Surface Antigen

202945 Prenatal Profile I With Hepatitis B Surface Antigen

202952 Prenatal Profile IV

202960 Glu+CBC/D/Plt+RPR+Rh+ABO+Ru...

Test Name

If you should have any questions regarding this change or its implementation, including questions about pricing, contact your

Labcorp sales representative. We appreciate the confidence you place in our expertise. Thank you for your continued business.

1. AAP Committee on Fetus and Newborn and ACOG Committee on Obstetric Practice. Kilpatrick SJ, Papile LA (Eds.). Guidelines for Perinatal Care, 8th Edition. 2017.

2. Workowski KA, Bachmann LH, Chan PA. Sexually Transmitted Diseases Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187.

3. Abara WE, Qaseem A, Schillie S, et al. Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice from the American College of Physicians and the Centers for Disease

Control and Prevention. Ann Intern Med. 2017 Dec 5;167(11)794-804.

4. Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR

Recomm Rep. 2018 Jan 12;67(1)1-31.

5. Centers for Disease Control and Prevention (CDC). Pregnancy and HIV, Viral Hepatitis, STD, & TB Prevention: Screening Recommendations. CDC web site: https://www.cdc.gov/nchhstp/

pregnancy/screening/index.html. Accessed June 21, 2022.

6. Centers for Disease Control and Prevention (CDC). Pregnancy and HIV, Viral Hepatitis, STD, & TB Prevention: Recommended Clinician Timeline for Screening for Syphilis, HIV, HBV, HCV,

Chlamydia, and Gonorrhea. CDC web site: https://www.cdc.gov/nchhstp/pregnancy/screening/clinician-timeline.html. Accessed June 21, 2022.

7. U.S. Department of Health and Human Services. Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021-2025). 2020; Washington, DC.

8. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. 2020;

v.2020.8. Accessed at www.HCVGuidance.org on June 27, 2022.

labcorp.com

DX-LET_158628-1022

Your patients deserve more,

so you should expect more from an NIPT

Different NIPTs

for different patient needs

Integrated Genetics offers three distinctly different NIPTs, each customizable

to suit individual screening needs. From screening for core trisomies to

genome-wide chromosomal abnormalities, we offer you a wider range of

NIPT options than any other commercial laboratory.

MaterniT® GENOME is

our most advanced and

robust NIPT offering.

A fully validated genomewide

NIPT, it can report

on every chromosome

down to the subchromosomal

level to tell

you even more about the

health of a baby.

MaterniT® 21 PLUS, now

with GENOME-Flex,

a new NIPT high risk

pathway, screens for

common trisomies (21,

18, 13), sex chromosome

aneuploidies, and can

be customized to screen

for more conditions (e.g.,

DiGeorge syndrome).

informaSeq® is similar to

MaterniT 21 PLUS,

but tests only for

common trisomies and

sex aneuploidies.

NIPT comparison and test details

MaterniT®

GENOME

MaterniT® 21

PLUS

informaSeq®

Detects trisomy 21 (Down syndrome)

Detects trisomy 18 (Edwards syndrome)

Detects trisomy 13 (Patau syndrome)

Detects sex chromosome abnormalities*

Reports fetal fraction

Reports fetal sex*

Multiple gestations†

Detects additional trisomies 22, 16‡

Detects select microdeletions, such as 22q11.2 (DiGeorge syndrome)†

Performed as early as 9 weeks

3-5 calendar day turnaround time

GENOME-Flex high risk pathway

Genome-wide analysis of all chromosomes

Reports on any trisomy or monosomy

Detects subchromosomal abnormalities ≥ 7 Mb

* Optional reporting † informaSeq is validated for singleton and twin pregnancies ‡ Optional reporting for MaterniT 21 PLUS

Test name Test no. Fetal sex opt-out

MaterniT 21 PLUS 451927 451951

MaterniT 21 PLUS with SCA* 451934 452112

MaterniT 21 PLUS with ESS** 451931 452136

MaterniT 21 PLUS with ESS and SCA 451937 452122

GENOME-Flex (Add On) 452104 n/a

GENOME-Flex (Add On) Redraw 452114 n/a

MaterniT GENOME 451941 452106

informaSeq prenatal test 550746 n/a

informaSeq with Y analysis 550757 n/a

informaSeq with X, Y analysis 550716 n/a

RAPID RESULTS

COST ESTIMATOR

CONVENIENT BLOOD DRAWS

GENETIC COUNSELING

EVERY MOM PLEDGE

ELECTRONIC MEDICAL RECORDS

Toll-free (within the US) 877.821.7266

Outside US: 858.202.9000

Fax: 858.202.9108

Domestic inquiries: askSQNMCS@labcorp.com

International inquiries:

sqnm-internationalupdates@labcorp.com

www.integratedgenetics.com

Sequenom Laboratories

3595 John Hopkins Court

San Diego, CA 92121

View short videos on genetic testing:

www.integratedgenetics.com/videos

Sequenom and Integrated Genetics are both brands of Laboratory

Corporation of America® Holdings. Sequenom, Inc. is a wholly

owned subsidiary of Laboratory Corporation of America Holdings.

Sequenom Center for Molecular Medicine, LLC d/b/a Sequenom

Laboratories, is a wholly owned subsidiary of Sequenom,

Inc. Integrated Genetics is a brand used by Esoterix Genetic

Laboratories, LLC, a wholly owned subsidiary of Laboratory

Corporation of America Holdings.

© 2018 Laboratory Corporation of America® Holdings. All rights reserved.

rep-1121-v2-1018 | L-17997-1018-2

© 2017 Laboratory Corporation of America® Holdings. All rights reserved.

rep-1121-v1-1117

WOMEN’S HEALTH AND

REPRODUCTIVE GENETICS

Understand

your cost options

Contact us to get your personalized estimate

We work directly with you to make sure our testing services are accessible

and you understand your out-of-pocket costs.

womenshealth.labcorp.com/transparency

844.799.3243

Please select a test or tests below:

NIPT

◦ MaterniT® 21 PLUS ◦ MaterniT GENOME

Carrier Screening

◦ Inheritest® Comprehensive Panel ◦ Inheritest Ashkenazi Jewish Panel

◦ Inheritest Society-guided Panel ◦ Inheritest Core Panel

◦ Inheritest 500 PLUS Panel ◦ Inheritest CF/SMA Panel

◦ Inheritest GeneSeq PLUS ◦ Inheritest Gene-specific Sequencing

Our Patient Engagement Program is designed to support your specific needs

Price transparency is important to us — our Every Mom Pledge team is ready to answer

questions about your insurance and cost options. Many insured patients will pay $0 based

on Labcorp internal billing data*; however, we have flexible programs to help meet personal

financial needs. This includes an opportunity to participate in our Moms Helping Moms of

Tomorrow initiative through which participants are eligible for a test cost of:

$299 for each MaterniT 21 PLUS, Inheritest Comprehensive, Society-guided, Ashkenazi

Jewish, Core, CF/SMA Panels, and Gene-specific sequencing

$399 for Inheritest 500 PLUS Panel and GeneSeq PLUS

$499 for MaterniT GENOME

*Based on internal Labcorp billing data; data includes claims adjudicated as non-covered and for which there was no patient responsibility

indicated by the insurance company. Patients should review their EOB statement from their insurance company, who should be contacted

directly with any questions about why the insurance company did not pay for these services.

©2022 Laboratory Corporation of America® Holdings. All rights reserved.

LC_PETP_L17562-0522-14

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