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the virology user manual - University College London Hospitals

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This is a CONTROLLED document.<br />

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.<br />

UCLH NHS FOUNDATION TRUST<br />

DEPARTMENT OF VIROLOGY<br />

USER MANUAL<br />

Version 15.0<br />

June 2013<br />

Page 1 of 21


This is a CONTROLLED document.<br />

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TABLE OF CONTENTS<br />

MISSION STATEMENT.......................................................................................................3<br />

INTRODUCTION .................................................................................................................3<br />

LOCATION ..........................................................................................................................4<br />

POSTAL ADDRESS............................................................................................................4<br />

WORKING HOURS .............................................................................................................4<br />

CONTACTING US DURING WORKING HOURS ...............................................................5<br />

CONTACTING US OUT OF WORKING HOURS................................................................5<br />

KEY CONTACTS - LABORATORY ....................................................................................5<br />

KEY CONTACTS – CONSULTANTS..................................................................................5<br />

SERVICES AVAILABLE .....................................................................................................6<br />

HIGH RISK SPECIMENS AND SAFETY ............................................................................7<br />

REQUEST FORMS..............................................................................................................7<br />

SPECIMEN VOLUME..........................................................................................................8<br />

COLLECTION OF SPECIMENS .........................................................................................8<br />

SPECIMEN LABELLING.....................................................................................................8<br />

TRANSPORT OF SPECIMENS ..........................................................................................9<br />

VIROLOGY CUT OFF TIMES .............................................................................................9<br />

COMMUNICATION OF RESULTS......................................................................................9<br />

MEDICAL ADVICE ............................................................................................................10<br />

LIMITATIONS AND UNCERTAINTIES .............................................................................10<br />

QUALITY ASSURANCE ...................................................................................................11<br />

COMPLAINTS ...................................................................................................................11<br />

TURNAROUND TIMES, SPECIMEN TYPES and INVESTIGATIONS .............................11<br />

RETENTION OF SPECIMENS AND REQUESTING OF ADDITIONAL TESTS ...............12<br />

REFERENCE LABORATORIES .......................................................................................12<br />

OTHER SEROLOGY.........................................................................................................12<br />

UCLH VIROLOGY TEST REPERTOIRE AND TURNAROUND TIMES ...........................14<br />

Page 2 of 21


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MISSION STATEMENT<br />

We aim to provide our <strong>user</strong>s with:<br />

An exemplary diagnostic <strong>virology</strong> laboratory service<br />

An expert clinical advisory service for <strong>the</strong> diagnosis, management and control of infections<br />

Assistance with <strong>the</strong> investigation of infectious disease outbreaks<br />

Advisory support for emerging viral infections<br />

A rapid response to comments, requests and criticisms<br />

INTRODUCTION<br />

The Virology Laboratory, <strong>University</strong> <strong>College</strong> <strong>London</strong> <strong>Hospitals</strong> NHS Foundation Trust is accredited<br />

by Clinical Pathology Accreditation (UK) Limited and receives in excess of 250,000 requests per<br />

year. In addition to <strong>the</strong> routinely available tests used to diagnose and monitor viral infections <strong>the</strong><br />

assay development group of <strong>the</strong> department develops and provides novel molecular diagnostic<br />

assays. The Virology Laboratory is an acknowledged reference laboratory for HIV, hepatitis B,<br />

hepatitis C and molecular diagnosis and has a special interest and expertise in:<br />

(1) HIV and o<strong>the</strong>r retroviral infections<br />

(2) Viral hepatitis, especially hepatitis B and C infections<br />

(3) Respiratory viral infections<br />

(4) Viral infections in <strong>the</strong> immunocompromised patient<br />

(5) Viral infections of <strong>the</strong> foetus<br />

(6) Molecular testing for MRSA, Chlamydia and GC.<br />

Medical and laboratory staff are happy to discuss any problems relating to <strong>the</strong> diagnosis and<br />

management of patients with viral infections and also with any issues about <strong>the</strong> quality of <strong>the</strong><br />

service provided to you.<br />

This <strong>manual</strong> is intended to enable all <strong>user</strong>s to make best use of <strong>the</strong> various services provided,<br />

ensuring an accessible, equitable and efficient service.<br />

This <strong>manual</strong> describes <strong>the</strong> clinical and laboratory services available to <strong>user</strong>s from <strong>the</strong> following<br />

areas:<br />

UCL <strong>Hospitals</strong> NHS Foundation Trust:<br />

o Eastman Dental Hospital<br />

o Heart Hospital<br />

o Hospital for Tropical Diseases (HTD)<br />

o National Hospital for Neurology and Neurosurgery (NHNN)<br />

o Royal <strong>London</strong> Hospital for Integrated Medicine<br />

o Royal National Throat, Nose and Ear<br />

o <strong>University</strong> <strong>College</strong> Hospital (UCH)<br />

o UCH Elizabeth Garrett Anderson (EGA) Wing<br />

o UCH Macmillan Cancer Centre<br />

Central and North West <strong>London</strong> NHS Foundation Trust (CNWL) (Mortimer Market<br />

and Archway Sexual Health Clinic)<br />

General Practitioners in Camden and Islington<br />

Camden & Islington Mental Health and Social Care Services Trust<br />

Podiatry & Family Planning Services<br />

Page 3 of 21


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LOCATION<br />

The Virology Laboratory, <strong>University</strong> <strong>College</strong> <strong>London</strong> <strong>Hospitals</strong> NHS Foundation Trust, <strong>London</strong> is<br />

located in 60 Whitfield Street.<br />

Nearest tube stations:<br />

Warren Street Tube Station<br />

(Nor<strong>the</strong>rn Line, Victoria Line)<br />

Goodge Street Tube Station<br />

(Nor<strong>the</strong>rn Line)<br />

POSTAL ADDRESS<br />

Virology Laboratory, Clinical Microbiology and Virology<br />

<strong>University</strong> <strong>College</strong> <strong>London</strong> <strong>Hospitals</strong> NHS Foundation Trust<br />

60 Whitfield Street<br />

<strong>London</strong><br />

W1T 4EU<br />

Internet address: www.uclh.nhs.uk<br />

WORKING HOURS<br />

Routine opening<br />

Monday to Friday 9 am to 5 pm.<br />

Specimens cannot be received outside <strong>the</strong>se times without prior arrangement.<br />

Out of hours<br />

Requests for <strong>the</strong> provision of laboratory testing outside normal working hours may be<br />

accommodated under exceptional circumstances. These should be arranged with <strong>the</strong> consultant<br />

on-call who may be air-called through <strong>the</strong> UCLH switchboard (020 3456 7890 / 0845 155 5000).<br />

Consultant advice<br />

Advice on <strong>the</strong> diagnosis, treatment and containment of viral infections in patients is available at any<br />

time through <strong>the</strong> 24 hour consultant led on-call service. The consultant providing this cover is<br />

always contactable through <strong>the</strong> UCLH switchboard (020 3456 7890 / 0845 155 5000).<br />

Page 4 of 21


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CONTACTING US DURING WORKING HOURS<br />

To contact us regarding laboratory enquiries<br />

General enquiries 020 344 78994<br />

Fax 020 344 79211<br />

Serology results 020 344 78994<br />

Molecular results 020 344 78964<br />

To contact us for medical advice<br />

Duty SpR 020 344 78986 / 78975<br />

07946 202 872 (mobile)<br />

CONTACTING US OUT OF WORKING HOURS<br />

On call Consultant via <strong>the</strong> UCLH Switchboard (020 3456 7890 / 0845 155 5000)<br />

ask for <strong>the</strong> on-call Virologist (pager 299)<br />

KEY CONTACTS - LABORATORY<br />

Mr Jim Waite<br />

Dr Paul Grant<br />

Serology Section Head<br />

e-mail: jim.waite@uclh.nhs.uk<br />

020 344 78979<br />

Molecular Section Head<br />

e-mail: paul.grant@uclh.nhs.uk<br />

020 344 78993<br />

KEY CONTACTS – CONSULTANTS<br />

Dr Eleni Nastouli<br />

Dr Mike Kidd<br />

Professor Deenan Pillay<br />

Consultant / Honorary Senior Lecturer<br />

e-mail: eleni.nastouli@uclh.nhs.uk<br />

020 344 78987<br />

Consultant Clinical Scientist / Honorary Senior Lecturer<br />

e-mail: michael.kidd@uclh.nhs.uk<br />

020 344 78991<br />

Professor / Hon Consultant, Head of Centre for Virology (UCL)<br />

e-mail: d.pillay@ucl.ac.uk<br />

020 3108 2117<br />

KEY CONTACTS – SERVICE<br />

Dr. Bruce Macrae<br />

Shelley Wilson<br />

Clinical Lead, Consultant<br />

e-mail: bruce.macrae@uclh.nhs.uk<br />

020 344 78331<br />

Virology Service Manager<br />

e-mail: shelley.wilson@uclh.nhs.uk<br />

020 344 78989<br />

Page 5 of 21


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Diagnosing viral infections: a brief guide<br />

SERVICES AVAILABLE<br />

Tests for recent infection:<br />

(1) Polymerase chain reaction (PCR) for detection of viral nucleic acid (ei<strong>the</strong>r RNA or DNA) is our<br />

front line assay to detect many viral pathogens. Preferred specimens are from <strong>the</strong> anatomical<br />

system where you think <strong>the</strong> virus is, as early as possible in <strong>the</strong> course of infection. For<br />

example, in suspected respiratory infection please collect respiratory specimens ra<strong>the</strong>r <strong>the</strong>n<br />

blood for antibodies and, in patients with vesicular rash or genital ulcers, send us a swab of a<br />

lesion ra<strong>the</strong>r than blood for antibodies.<br />

(2) In non-specific illnesses such as malaise, tiredness, myalgia etc., unless <strong>the</strong>re are localising<br />

symptoms/signs, it is not worth sending blood specimens without discussion with Virology.<br />

(3) Blood specimens (EDTA) remain useful, especially for HIV, hepatitis viruses, HTLV,<br />

parvovirus B19, measles, rubella and EBV. Please do not send blood for respiratory or<br />

gastrointestinal viruses.<br />

(4) Please provide brief patient clinical details with duration of illness (date of onset), which<br />

allows us to choose appropriate tests.<br />

(5) Suspected viral haemorrhagic fever or SARS or o<strong>the</strong>r exotic viruses in returning traveller:<br />

contact duty Virologist and Infectious/Tropical Diseases team for discussion as investigating<br />

for <strong>the</strong>se pathogens might have significant infection control implications.<br />

(6) Our laboratory also provides a diagnostic service for syphilis (send EDTA blood for serology<br />

and/or ulcer swab for PCR) and for Lyme disease (send EDTA blood for serology).<br />

(7) Molecular MRSA testing service (send red topped swab).<br />

(8) Molecular Chlamydia and GC testing service.<br />

Please see also table showing diseases and specimens to be collected for virological diagnosis<br />

later in this <strong>manual</strong>.<br />

Tests for immunity:<br />

(1) Post-vaccine testing for immunity is NOT routinely recommended for measles, mumps, VZV<br />

and hepatitis A as <strong>the</strong> assays used are reliable to detect vaccine induced IgG.<br />

(2) Tell us about <strong>the</strong> dates and doses of HBV or rubella vaccines administered.<br />

(3) We can test for previous exposure and / or immunity to: CMV, EBV, parvovirus B19, hepatitis<br />

A, hepatitis B and VZV.<br />

Urgent specimens<br />

(1) Pregnant, in recent contact with a case of chickenpox: if <strong>the</strong>re is clear history of chickenpox in<br />

<strong>the</strong> past, no testing is necessary. O<strong>the</strong>rwise, please supply details of date of contact and type<br />

of contact (face-to-face / same room for 15 mins / own child).<br />

(2) For all o<strong>the</strong>r urgent testing please phone <strong>the</strong> laboratory so that we can identify your patient’s<br />

specimen. Include your contact number on <strong>the</strong> request form.<br />

What NOT to do…….<br />

In order to get <strong>the</strong> best out of <strong>the</strong> diagnostic service, please:<br />

<br />

<br />

<br />

<br />

avoid <strong>the</strong> terms ‘viral titres’ and ‘TORCH screen’, <strong>the</strong>y are confusing and obsolete<br />

do not send ANY unsigned request forms, especially for HIV testing<br />

do not send request forms without <strong>the</strong> patient’s date of birth and your contact number<br />

do not send specimens from suspected chronic fatigue syndrome: contact Virologist first for<br />

discussion.<br />

Page 6 of 21


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HIGH RISK SPECIMENS AND SAFETY<br />

Pathogens are classified in hazard groups 1 to 4, with hazard group 1 being non-pathogenic to<br />

humans and hazard group 4 <strong>the</strong> most dangerous pathogens to humans. Hazard group 4<br />

pathogens include viruses causing viral haemorrhagic fever (Ebola, Marburg, Lassa, CCHF)<br />

viruses.<br />

Specimens from patients with a suspected viral haemorrhagic fever (a history of having returned<br />

from Africa, Asia and South America within 21 days) are HIGH RISK. Contact <strong>the</strong> on-call Virologist<br />

before sending any specimens to <strong>the</strong> laboratories. The consultant virologist will advise on <strong>the</strong><br />

appropriate specimens to be collected and appropriate transport. High risk specimens must be<br />

sent to <strong>the</strong> laboratory using appropriate packaging.<br />

VIRAL HAEMORRHAGIC FEVER (EBOLA, MARBURG, LASSA, CCHF)<br />

AVIAN INFLUENZA / MERS CORONAVIRUS / H7N9 INFLUENZA<br />

Contact Virologist immediately - Air call on call Virologist (pager 299) through UCLH<br />

switchboard (020 3456 7890 / 0845 155 5000).<br />

REQUEST FORMS<br />

Request forms are clearly labelled as “Virology” request forms and have a bag attached for <strong>the</strong><br />

specimen. Please send requests for Virology on a separate form from requests going to o<strong>the</strong>r<br />

departments. Ideally serology and molecular requests should be sent on separate request forms.<br />

Specimens accompanied by <strong>the</strong> wrong, or inadequately completed, request form may result in<br />

unnecessary delays.<br />

The minimum data we require for patient details marked on each request form are:<br />

Patient surname AND first name (please use ONLY capital letters)<br />

Hospital Number (for GP’s – your reference number)<br />

Date of Birth<br />

Sex<br />

Ward or Address for report<br />

Requestor identification and contact details<br />

For hospital patients, please provide details of <strong>the</strong> patient’s consultant<br />

Date and time specimen taken<br />

Type of specimen<br />

Tests required. Please avoid general terms such as “viral screen” as this may lead to<br />

delays in processing <strong>the</strong> specimen appropriately.<br />

O<strong>the</strong>r useful details<br />

Bleep number or mobile number, in order to phone significant results<br />

All relevant clinical details including:<br />

o Date of onset and duration of illness<br />

o History of foreign travel including return dates<br />

o If pregnant, indicate <strong>the</strong> gestational age<br />

o Relevant treatment history<br />

The importance of accuracy when completing <strong>the</strong> form, labelling <strong>the</strong> specimen, and <strong>the</strong><br />

provision of relevant clinical details cannot be over-emphasised. For patient safety reasons,<br />

mislabelled specimens will not be processed.<br />

Page 7 of 21


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SPECIMEN VOLUME<br />

For most single investigations a minimum volume of 4ml of blood is required. Larger<br />

volumes may be needed for multiple investigations or two separate specimens where both<br />

serological and molecular testing is required. Neonatal / paediatric specimens should<br />

indicate <strong>the</strong> priority tests when small volumes are sent.<br />

Please contact <strong>the</strong> laboratory for fur<strong>the</strong>r guidance on specimen volumes if only a small volume is<br />

available or if sending separated plasma or serum.<br />

COLLECTION OF SPECIMENS<br />

In order to provide you with <strong>the</strong> best quality results, it is essential that good specimens are<br />

collected properly and at <strong>the</strong> appropriate time. It is also important that <strong>the</strong>y are transported to <strong>the</strong><br />

laboratory without undue delay. This enables <strong>the</strong> laboratory and <strong>the</strong> medical staff to provide a<br />

meaningful report and an interpretation relevant to <strong>the</strong> patient's illness.<br />

Inappropriate specimens or those that are damaged or leaking are liable to be discarded. Should<br />

this occur, every attempt will be made to inform <strong>the</strong> <strong>user</strong> that a second specimen may be required.<br />

Specimen collection<br />

Please ensure that <strong>the</strong> correct specimen container is used. If unsure which specimen type to<br />

examine or how to collect a particular specimen type, please contact <strong>the</strong> laboratory (020 344<br />

78994) for advice.<br />

Dry swabs are not appropriate. Use Copan brand swabs which come with <strong>the</strong>ir own vial of<br />

transport medium in <strong>the</strong> same packet. This has a long shelf life at room temperature. It is ideal for<br />

genital ulcers, vesicular rash, eye swabs and respiratory swabs.<br />

These can be ordered through NHS Logistics; code HHD 116 for <strong>the</strong> small 1mL container.<br />

Use <strong>the</strong> swab provided: snap off into <strong>the</strong> bottle and replace cap.<br />

CSF should be sent in a sterile Universal container not in transport medium.<br />

Please use red topped double headed swabs for molecular MRSA screening.<br />

The laboratory’s preferred blood specimen type is an EDTA (purple topped container) blood for<br />

serological as well as molecular tests. EDTA specimens are essential for molecular tests.<br />

For serological tests only, a clotted (red top) or SST (yellow top) blood may be substituted for<br />

EDTA blood.<br />

SPECIMEN LABELLING<br />

Complete patient details must be clearly marked on BOTH <strong>the</strong> request form AND <strong>the</strong> specimen<br />

container before insertion into <strong>the</strong> plastic bag and before it is sealed ready for transportation. Do<br />

not use pins or staples as this is hazardous.<br />

The specimen must be labelled with <strong>the</strong> same patient details as that on <strong>the</strong> request form.<br />

Please ensure that <strong>the</strong> full patient name and <strong>the</strong> date of specimen collection are legible.<br />

The importance of accuracy when completing <strong>the</strong> form, labelling <strong>the</strong> specimen, and <strong>the</strong><br />

provision of relevant clinical details cannot be over-emphasised. For patient safety reasons,<br />

mislabelled specimens will not be processed.<br />

Page 8 of 21


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TRANSPORT OF SPECIMENS<br />

Specimens should be sent direct to <strong>the</strong> Virology Specimen Reception at 60 Whitfield Street W1T<br />

4EU.<br />

Routine specimens<br />

Routine specimens from UCH should be sent via <strong>the</strong> pneumatic tube system. Specimens from<br />

o<strong>the</strong>r sites, including GPs, should be sent using <strong>the</strong> regular courier service to 60 Whitfield Street.<br />

Specimens may also be sent by post. Please refer to <strong>the</strong> Trust policy:<br />

http://insight/pandp/Trustwide%20policies1/Specimen%20and%20PTS%20Transport%20Policy%2<br />

0and%20Procedure.pdf<br />

Urgent requests – refer to Page 5 for <strong>the</strong> correct numbers<br />

During working hours – discuss with <strong>the</strong> laboratory first<br />

Out-of-hours – discuss with on-call Virologist, including transport to <strong>the</strong> laboratory<br />

On rare occasions, <strong>the</strong> quickest way to get an urgent specimen to <strong>the</strong> Virology laboratory may be<br />

for a member of ward staff to carry it instead of calling a medical courier. In this situation, staff<br />

should always carry <strong>the</strong> specimen in a suitable rigid container. Such containers should be available<br />

on each ward. Spare/replacement containers can be obtained from Virology Specimen Reception.<br />

The sender is responsible for ensuring <strong>the</strong> health and safety of any courier or taxi service<br />

that is used to transport specimens to <strong>the</strong> Clinical Virology laboratory.<br />

If sent by post or by external courier, specimens must be in a sealed container, sealed in a plastic<br />

bag. The primary container must be surrounded by sufficient absorbent packing material to take up<br />

any leakage from <strong>the</strong> primary container during transit. Bags must <strong>the</strong>n be placed in an approved<br />

outer container which satisfies current postal or o<strong>the</strong>r transport regulations.<br />

Guidance on <strong>the</strong> transporting of specimens, including specimens requiring category A transport<br />

when being transported by road in <strong>the</strong> UK, may be found at<br />

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/48846/guidancenote-17.pdf.<br />

VIROLOGY CUT OFF TIMES<br />

Virology cut-off times for processing specimens with a same day turnaround time (TAT).<br />

Specimen type<br />

Respiratory specimen<br />

Assay<br />

Respiratory PCR<br />

(Influenza, RSV, ParaFlu,<br />

Metapneumovirus, Adenovirus)<br />

Cut for time for<br />

processing<br />

Results<br />

available<br />

11.00 16.30<br />

Specimens not<br />

processed on:<br />

Sundays, when<br />

no outbreaks<br />

Faeces<br />

Gastro PCR<br />

(Norovirus, Rotavirus,<br />

Adenovirus)<br />

11.00 16.30<br />

Sundays, when<br />

no outbreaks<br />

COMMUNICATION OF RESULTS<br />

Electronic reports are exported to downstream systems (to CDR for UCLH, to OASIS for<br />

Mortimer Market and Archway clinics, and for General Practitioners to GPLINKS, GPPORTAL<br />

and <strong>the</strong> Community Browser).<br />

Automatic electronic faxing of reports is used for some requestors and this is set up within <strong>the</strong><br />

Laboratory Information System.<br />

Non-electronic reports are printed twice a day and are dispatched by post Monday to Friday.<br />

Page 9 of 21


This is a CONTROLLED document.<br />

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.<br />

All clinically relevant and urgent positive results are telephoned out to our <strong>user</strong>s by one of <strong>the</strong><br />

medical staff. For reasons of confidentiality, results are only faxed to “safe-haven fax numbers”.<br />

MEDICAL ADVICE<br />

Advice on <strong>the</strong> diagnosis, treatment and containment of viral infections in patients is available at any<br />

time through <strong>the</strong> 24 hour consultant led on-call service. The consultant providing this cover is<br />

always contactable through <strong>the</strong> UCLH switchboard (020 3456 7890 / 0845 155 5000).<br />

LIMITATIONS AND UNCERTAINTIES<br />

A variety of key factors impact upon <strong>the</strong> certainty of results of virological testing.<br />

Pre testing<br />

Outside factors that can affect <strong>the</strong> outcome of investigations include <strong>the</strong> delay from specimen<br />

collection to testing and sample storage conditions prior to and during transport to <strong>the</strong> laboratory.<br />

For quantitative molecular testing in particular, a significant delay in transit to <strong>the</strong> laboratory may<br />

result in inaccurate estimation of viral loads.<br />

Note that if a patient has recently received a blood transfusion or blood products, this can result in<br />

misleading antibody test results.<br />

Most assays have not been validated for cadaveric specimens.<br />

Swabs should be in viral transport medium. Swabs in bacterial transport medium may not be<br />

tested.<br />

Whole bloods should be sent to <strong>the</strong> laboratory to arrive within a maximum of 72 hours of being<br />

taken. If sending is likely to be delayed, whole bloods may be separated and stored as<br />

plasma/serum prior to transportation. This should be performed as soon as possible after<br />

collection.<br />

Plasma or serum samples may be stored at 2-8C for no longer than 7 days. They should be frozen<br />

at -20C or below if being stored longer. Repeated freeze-thaw cycles may reduce assay sensitivity.<br />

Note that EDTA blood is required for molecular assays, clotted or heparinised specimens should<br />

not be sent, <strong>the</strong>y may give rise to erroneous results.<br />

Testing<br />

Results from specimens that are heat inactivated, haemolysed, lipaemic or heavily bacterially<br />

contaminated may not be accurate. Such specimens may be unsuitable for testing and should not<br />

be sent.<br />

Post testing<br />

All results must be interpreted with reference to clinical information. In many cases clinical<br />

comments will be provided with results but it may not be possible to properly interpret results<br />

where clinical information has not been provided with <strong>the</strong> request. Medical staff are available in <strong>the</strong><br />

laboratory during working hours and on-call (out of hours) to discuss cases and provide guidance<br />

on <strong>the</strong> diagnosis and management of infectious diseases.<br />

The absence of detectable markers does not necessarily exclude <strong>the</strong> possibility of infection,<br />

especially in <strong>the</strong> early acute phase.<br />

Page 10 of 21


This is a CONTROLLED document.<br />

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.<br />

QUALITY ASSURANCE<br />

The laboratory has full accreditation with Clinical Pathology Accreditation (CPA) (UK) Ltd. This<br />

accreditation is an external audit of our ability to provide a service of high quality in meeting all <strong>the</strong><br />

necessary performance standards. For full details please refer to <strong>the</strong> CPA website www.cpauk.co.uk.<br />

The results sent out by this laboratory are of <strong>the</strong> highest possible quality. To this end we have a<br />

Quality Management System (QMS) and participate in <strong>the</strong> UK National External Quality<br />

Assessment Scheme (UKNEQAS) and Quality Control for Molecular Diagnostics (QCMD) for a<br />

wide range of virological investigations. UKNEQAS/QCMD are central organisations that operate<br />

on an international wide basis and monitor our performance regularly by sending simulated<br />

samples for analysis. Where tests performed are not covered by UKNEQAS or QCMD, alternative<br />

sources of EQA material or exchange of samples with o<strong>the</strong>r laboratories will be used to provide<br />

external quality assurance. Our results and ongoing performance are available for inspection.<br />

All testing protocols and results are subject to strict internal quality control and regular audits.<br />

The Department holds a monthly Quality Meeting where internal and external quality is monitored.<br />

The meeting receives reports on audits of <strong>the</strong> quality system and looks at turnaround times and<br />

error reports.<br />

An annual User Survey is undertaken to receive feedback on <strong>the</strong> service and to review testing<br />

profiles and indicate where improvements to <strong>the</strong> overall service may be made.<br />

COMPLAINTS<br />

If you wish to make a complaint, please contact <strong>the</strong> Virology Service Manager as detailed in <strong>the</strong><br />

earlier section and your complaint will be dealt with promptly.<br />

TURNAROUND TIMES, SPECIMEN TYPES and INVESTIGATIONS<br />

Note that <strong>the</strong> laboratory’s preferred blood specimen type is an EDTA (purple topped<br />

container) blood and this is essential for molecular tests. For serological tests a clotted (red<br />

top) or SST (yellow top) blood is acceptable.<br />

IF BOTH VIRAL SEROLOGY (ANTIBODY TESTING) and MOLECULAR (PCR)<br />

INVESTIGATIONS ARE REQUIRED, PLEASE SEND TWO BLOOD SPECIMENS<br />

In <strong>the</strong> following sections you will find details of <strong>the</strong> different diagnostic tests available in our lab, <strong>the</strong><br />

specimen required and <strong>the</strong> turnaround time for results. The tests are presented in <strong>the</strong> following<br />

groups:<br />

Hepatitis viruses (hepatitis A, hepatitis B, hepatitis C, delta and hepatitis E viruses)<br />

Retroviruses (HIV-1, HIV-2, HTLV)<br />

Herpes viruses (CMV, EBV, herpes simplex virus, VZV, HHV-6 & 7, KSHV [aka HHV8])<br />

Exotic/tropical viruses (including arboviruses, dengue, West Nile virus, Lassa fever virus,<br />

Avian influenza H5N1 )<br />

O<strong>the</strong>r viruses (or infective agents for which routine testing is performed in <strong>the</strong> Virology<br />

laboratory) in alphabetical order<br />

o Includes Lyme and syphilis testing<br />

Screening batteries (Antenatal, Occupational Health, Needlestick donor and Needlestick<br />

recipient screening batteries)<br />

Molecular MRSA results are normally reported within <strong>the</strong> same working day if received by<br />

2:30pm.<br />

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<br />

<br />

Chlamydia/GC molecular results are normally available with 48-72 hours of receipt of<br />

specimen.<br />

O<strong>the</strong>r reference laboratory investigations.<br />

Turnaround time in all <strong>the</strong> following tables is <strong>the</strong> number of working days (Monday to<br />

Friday, excepting Public Holidays) from receipt of <strong>the</strong> specimen to result availability.<br />

RETENTION OF SPECIMENS AND REQUESTING OF ADDITIONAL TESTS<br />

Original blood specimens are retained for approximately one week. Plasma from ante-natal<br />

booking blood specimens, needlestick related specimens and aliquots from specimens for<br />

molecular tests are retained for 2 years. Within this time frame, additional tests can be requested<br />

on <strong>the</strong>se specimens by telephone or fax. The corresponding period of retention for urine, swab and<br />

stool specimens is 3 weeks.<br />

REFERENCE LABORATORIES<br />

Samples may be referred to Reference laboratories for more specific tests where routine testing at<br />

UCLH is not provided. These are listed throughout <strong>the</strong> tables on following pages.<br />

If an investigation you require is not listed in <strong>the</strong> following tables, please call <strong>the</strong> <strong>virology</strong><br />

department for advice. We will receive <strong>the</strong> specimen in our laboratory and refer it to <strong>the</strong> most<br />

appropriate reference facility.<br />

Turnaround times for <strong>the</strong> different tests vary. Please consult with <strong>the</strong> laboratory if specific<br />

information re turnaround times is required. Fur<strong>the</strong>r information may be obtainable direct from <strong>the</strong><br />

individual reference laboratories. Full addresses of <strong>the</strong> reference laboratories used and <strong>the</strong>ir o<strong>the</strong>r<br />

contact details are available on request.<br />

OTHER SEROLOGY<br />

Serological and antibody/antigen detection:<br />

Investigations for <strong>the</strong> following are performed:<br />

o Anti-streptolysin-O (ASO)<br />

o Brucella antibodies<br />

o Investigations for H. pylori (Antigen test performed on faeces)<br />

o Mycoplasma antibody<br />

o Syphilis antibody on CSF<br />

o Toxoplasma antibody<br />

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TABLE SHOWING DISEASES AND SPECIMENS TO BE COLLECTED FOR VIROLOGICAL DIAGNOSIS<br />

= Preferred specimen = Second choice specimen Lesion specimens Respiratory specimens ( one is enough) O<strong>the</strong>r specimens Blood<br />

System involved<br />

Systemic<br />

Respiratory<br />

Gastrointestinal<br />

Nervous system<br />

Ophthalmic<br />

Genito-urinary<br />

(GUM)<br />

Skin and<br />

mucosa<br />

Haematological<br />

Clinical features<br />

Common<br />

pathogens<br />

Vesicle<br />

Eye<br />

Copan swabs in VTM<br />

Conjunctival<br />

Genital<br />

Mouth /<br />

oral<br />

Throat<br />

and<br />

nasal<br />

Throat<br />

gargle<br />

Sputum<br />

O<strong>the</strong>rs<br />

NPA<br />

(children)<br />

Pyrexia<br />

Influenza (in <strong>the</strong><br />

season)<br />

<br />

EBV (


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UCLH VIROLOGY TEST REPERTOIRE AND TURNAROUND TIMES<br />

In <strong>the</strong> following sections you will find details of <strong>the</strong> different diagnostic tests available in our laboratory, <strong>the</strong> specimen required and <strong>the</strong> turnaround time for<br />

results. For most single investigations a minimum of 4mls of blood is required. Larger volumes may be needed for multiple investigations or<br />

two separate specimens where both serological and molecular testing is required. Neonatal / paediatric specimens should indicate <strong>the</strong> priority<br />

tests when small volumes are sent.<br />

HEPATITIS VIRUSES<br />

VIRUS TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME<br />

Hepatitis A Hepatitis A IgG + IgM EDTA blood Daily (Mon – Fri) 1-2 working days<br />

Hepatitis B<br />

Hepatitis C<br />

Hepatitis D<br />

Hepatitis E<br />

RETROVIRUSES<br />

All serological markers including anti-HBs EDTA blood Daily (Mon – Fri) 1-2 working days Same day if urgent<br />

HBsAg quantitation EDTA blood On request 2-7 working days<br />

HBV DNA quantification<br />

(with or without “e” markers: please specify)<br />

EDTA blood Twice weekly (Tues & Thurs) 3-7 working days<br />

HBV genotyping/resistance testing EDTA blood Twice weekly (Mon & Weds) 5-10 working days<br />

Antibody EDTA blood Daily (Mon – Fri) 1-2 working days Same day if urgent<br />

HCV RNA detection/quantification EDTA blood Twice weekly (Tues & Thurs) 3-7 working days<br />

HCV genotyping (including resistance) EDTA blood Twice weekly (Mon & Weds) 5-10 working days<br />

Delta virus (HDV) serology screen EDTA blood Weekly 7-10 working days<br />

HDV RNA detection / quantification EDTA blood Fortnightly 5-20 working days<br />

Antibody EDTA blood Weekly 7-10 working days<br />

HEV RNA EDTA blood Monthly / On request 15 working days<br />

VIRUS TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME<br />

HIV-1 and 2<br />

“HIV test” (antibody / antigen detection) EDTA blood Daily (Mon – Fri) 1-2 working days Same day if urgent<br />

HIV-1 RNA (viral load) EDTA blood 3-5 times / week 2-5 working days<br />

HIV-1 genome (DNA and RNA) EDTA blood Weekly (Mon) 2-6 working days<br />

HIV-1 resistance testing EDTA blood Twice weekly (Mon & Weds) 3-9 working days<br />

HIV-2 RNA (viral load) EDTA blood Fortnightly 5-20 working days<br />

HIV-2 genome (DNA and RNA) EDTA blood Fortnightly 5-20 working days<br />

HTLV-1 and 2 IgG screening EDTA blood Daily (Mon – Fri) 1-3 working days


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HERPESVIRUSES<br />

If <strong>the</strong> specimen type is not specified contact <strong>the</strong> Medical Virologist<br />

VIRUS TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME<br />

Cytomegalovirus<br />

(CMV)<br />

Epstein Barr Virus<br />

(EBV)<br />

Herpes Simplex<br />

(HSV)<br />

Varicella Zoster<br />

Virus<br />

(VZV)<br />

Human Herpes<br />

viruses 6 & 7<br />

CMV IgG + IgM EDTA blood Daily (Mon – Fri) 1-2 working days<br />

CMV IgG avidity EDTA blood On demand (Contact Medical Virologist) 2 working days<br />

CMV DNA qualitative detection<br />

(This test has replaced CMV DEAFF<br />

test and CMV culture)<br />

EDTA blood, CSF, urine,<br />

broncho-alveolar lavage<br />

3 times/week (Mon, Weds, Fri) 2-3 working days<br />

CMV DNA quantification EDTA blood Twice weekly (Tues & Thurs) 2-7 working days<br />

EBV IgG antibodies EDTA blood Weekly (Weds) 3-8 working days<br />

EBV IgM EDTA blood Weekly (Thurs) 3-8 working days<br />

EBV DNA qualitative detection CSF 3 times / week (Mon, Weds, Fri) 2-3 working days<br />

EBV DNA quantification EDTA blood Twice weekly (Tues & Thurs) 2-7 working days<br />

Serology (usually not helpful)<br />

Please telephone to discuss<br />

HSV-1 and 2 DNA detection (This test<br />

has replaced both tissue culture and<br />

EM of vesicle fluid)<br />

VZV IgG screen<br />

VZV IgM (Rarely useful: CSF or swab<br />

of skin/mucosal lesion for VZV-DNA<br />

detection is usually more helpful)<br />

VZV DNA detection<br />

EDTA blood Reference lab test (PHE, Colindale) 15 working days<br />

Swab in VTM, CSF,<br />

broncho-alveolar lavage<br />

EDTA blood<br />

EDTA blood<br />

Swab in VTM, CSF<br />

Swabs: Daily (Mon - Fri)<br />

O<strong>the</strong>r (e.g. CSF):<br />

3 times / week (Mon, Weds, Fri)<br />

3 times / week (Urgent samples on<br />

demand)<br />

On demand if clinically indicated: contact<br />

Medical Virologist<br />

Swabs: Daily (Mon - Fri)<br />

O<strong>the</strong>r (e.g. CSF):<br />

3 times / week (Mon, Weds, Fri)<br />

2-3 working days<br />

2-6 working days<br />

Same day if urgent<br />

2-6 working days<br />

Up to 5 working days<br />

HHV6 & HHV7 DNA detection CSF Reference lab test (PHE, Colindale) 15 working days<br />

Human Herpes HHV8 DNA qualitative detection EDTA blood 3 times / week (Mon, Weds, Fri) Up to 5 working days<br />

virus 8 HHV8 DNA quantification EDTA blood Weekly (Fri) Up to 20 working days


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EXOTIC / TROPICAL VIRUSES<br />

VIRUS TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME<br />

Exotic viruses e.g<br />

dengue, yellow<br />

fever, West Nile<br />

Virus<br />

Antibody / viral nucleic acid<br />

EDTA blood<br />

Reference lab test<br />

(PHE Porton Down)<br />

15 working days<br />

SCREENING BATTERIES<br />

BATTERY TESTS SPECIMEN FREQUENCY OF TEST TURNAROUND TIME<br />

Antenatal screen HBsAg, HIV, syphilis & Rubella IgG EDTA blood Daily (Mon – Fri) 1-2 working days Same day if urgent<br />

Occupational Health<br />

Screen<br />

Needlestick / sharps<br />

DONOR screen<br />

Needlestick / sharps<br />

RECIPIENT<br />

May include: HBsAg, anti-HBs,<br />

Rubella IgG, VZV IgG & Measles IgG<br />

EDTA blood<br />

Daily (Mon – Fri) except<br />

for VZV IgG (2 times / week )<br />

HBsAg, HIV, anti-HCV, syphilis EDTA blood Daily (Mon – Fri) 1 working day<br />

Save sample<br />

EDTA blood<br />

2-6 working days Same day if urgent<br />

These baseline samples are archived. They are only tested in <strong>the</strong> event<br />

that a follow-up test on <strong>the</strong> individual shows <strong>the</strong>m to have an infection<br />

that might have been acquired from <strong>the</strong> sharps injury.


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OTHER VIRUSES (OR INFECTIVE AGENTS FOR WHICH ROUTINE TESTING IS PERFORMED IN THE VIROLOGY LABORATORY) IN ALPHABETICAL ORDER<br />

VIRUS / AGENT TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME<br />

16S PCR 16S rDNA identification of bacterial pathogens Tissue Weekly 5-7 working days<br />

Adenovirus<br />

Faecal adenovirus (serotypes 40 & 41) DNA<br />

detection by PCR<br />

Adenovirus DNA detection by PCR<br />

(This test has replaced direct<br />

immunofluorescence and tissue culture)<br />

Adenovirus DNA quantification<br />

Faeces<br />

Nasopharyngeal aspirate / throat<br />

washing, conjunctival swab in<br />

VTM 7<br />

EDTA blood. Stem cell transplant<br />

patients only. (For o<strong>the</strong>r<br />

patients/specimens contact <strong>the</strong><br />

on-call Virologist)<br />

Daily (Mon – Sat) if<br />

required<br />

Daily (Mon – Sat) if<br />

required<br />

Twice Weekly (Tues &<br />

Thurs)<br />

1-2 working days<br />

1-2 working days<br />

2-7 working days<br />

Anti-Streptolysin O ASO EDTA Blood Daily (Mon – Fri) 1-2 working days<br />

BK virus<br />

Brucella<br />

Chlamydia and<br />

Gonorrhoea<br />

Serology no longer available from PHE. A PCR<br />

is under development.<br />

Confirmatory testing<br />

CT/GC NAAT screen<br />

Please discuss with <strong>the</strong><br />

laboratory.<br />

EDTA blood Daily (Mon – Fri) 1-2 working days<br />

1. For first catch urine (FCU),<br />

transport to laboratory ideally<br />

within 48 hours (unless placed<br />

directly in to Aptima Urine<br />

transport media, GUM ONLY).<br />

2. Specimens older than 7 days<br />

can not be processed.<br />

3. Specimens usually retained<br />

for 7 days after testing.<br />

4. Unisex/self taken vaginal<br />

swabs routinely available for<br />

GUM Clinic specimens. All<br />

o<strong>the</strong>r <strong>user</strong>s by local<br />

arrangement.<br />

Reference lab test<br />

(BRU, Liverpool)<br />

Daily (Mon – Fri)<br />

1-3 working days<br />

Same day if urgent


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VIRUS / AGENT TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME<br />

Enteroviruses e.g.<br />

coxsackie A and B,<br />

ECHOvirus and<br />

poliovirus<br />

Enterovirus PCR<br />

Enterovirus IgM<br />

CSF in meningitis or encephalitis<br />

Faeces (or rectal swab in VTM if<br />

no stool specimen is available),<br />

throat swab in VTM<br />

EDTA blood<br />

Twice weekly (Weds &<br />

Fri)<br />

Reference lab test<br />

(PHE Epsom)<br />

2-7 working days<br />

10 working days<br />

H pylori Stool antigen Faeces Daily (Mon – Fri) 1-2 working days<br />

Lyme<br />

Measles<br />

Screening antibody test<br />

Confirmatory antibody tests<br />

Measles RNA detection<br />

Measles IgM<br />

Measles IgG screen (Limited indications –<br />

please contact Virologist to discuss.)<br />

EDTA blood<br />

EDTA blood, CSF<br />

Throat swab in VTM<br />

Urine<br />

EDTA blood<br />

Oral fluid (“oracol”)<br />

EDTA blood<br />

EDTA blood<br />

Daily (Mon – Fri)<br />

(Urgent samples on<br />

demand)<br />

Reference lab test<br />

(PHE Porton Down,<br />

Southampton)<br />

Reference lab test<br />

(PHE CfI, Colindale)<br />

Reference lab test<br />

(PHE CfI, Colindale)<br />

Daily (Mon – Fri)<br />

(Urgent samples on<br />

demand)<br />

MRSA MRSA screen Red topped swab Daily (Mon – Fri)<br />

Mycoplasma<br />

Parvovirus B19<br />

Parvovirus IgG and IgM<br />

Parvovirus DNA detection<br />

EDTA Blood<br />

EDTA blood<br />

EDTA blood<br />

Twice a week (day<br />

varies)<br />

Twice weekly (Tues &<br />

Thurs)<br />

Reference lab tests<br />

(PHE, Colindale)<br />

2-3 working days<br />

Same day if urgent<br />

15 working days<br />

15 working days<br />

10 working days<br />

1-3 working days<br />

Same day if urgent<br />

1-2 working days<br />

Same day if urgent<br />

2-3 working days<br />

1-7 working days<br />

15 working days


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VIRUS / AGENT TEST SPECIMEN FREQUENCY OF TEST TURNAROUND TIME<br />

Respiratory viruses<br />

i.e. influenza<br />

viruses, RSV, Parainfluenza<br />

viruses,<br />

adenovirus and<br />

metapneumovirus<br />

Viral nucleic acid detection by PCR<br />

(This test has replaced direct<br />

immunofluorescence and viral culture)<br />

Nose & throat swab in VTM,<br />

BAL, NPA.<br />

Daily (Mon – Sat)<br />

H5 Influenza A: Contact Virologist immediately - Air call Medical Virologist through <strong>the</strong> UCLH switchboard<br />

Rotavirus Rotavirus RNA detection Faeces, vomit<br />

Rubella<br />

Syphilis<br />

Toxoplasma<br />

Daily (Mon – Sat) if<br />

required<br />

Rubella IgG screen EDTA blood Daily (Mon – Fri)<br />

Rubella IgM EDTA blood Weekly (Thurs)<br />

Treponema pallidum antibody detection (and<br />

additional serological tests, including reference<br />

lab testing at PHE CfI Colindale, as appropriate)<br />

EDTA blood (For o<strong>the</strong>r specimens<br />

including CSF, contact<br />

Microbiology Serology lab on<br />

UCH 78994)<br />

Daily (Mon – Fri)<br />

1-2 working days<br />

1-2 working days<br />

1-2 working days<br />

Same day if urgent<br />

1-2 working days<br />

Same day if urgent<br />

1-2 working days<br />

Same day if urgent<br />

Treponema pallidum DNA PCR Swab in VTM Daily (Mon – Fri) Up to 5 working days<br />

IgG and IgM antibody EDTA blood Daily (Mon – Fri) 1-2 working days<br />

Confirmatory antibody tests<br />

EDTA blood<br />

Reference lab test<br />

(PHE, Colindale)<br />

15 working days


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OTHER INVESTIGATIONS WHERE TESTS ARE PERFORMED BY REFERENCE LABORATORIES<br />

VIRUS / AGENT / TESTS SPECIMEN REFERENCE LABORATORY<br />

Anaplasma (Ehrlichia) serology Blood PHE, Porton Down<br />

Anti-DNase B (Streptococcal) antibodies Blood PHE, Colindale<br />

Aspergillus serology Clotted blood / serum Mycology Reference Centre, Leeds<br />

Avian antigens Clotted blood / serum Mycology Reference Centre, Leeds<br />

B pseudomallei (melioidosis) Clotted blood / serum PHE, Colindale<br />

Bartonella serology Blood PHE, Colindale<br />

Blastomyces serology Clotted blood / serum Mycology Reference Laboratory, Bristol<br />

Bordetella pertussis serology Blood PHE, Colindale<br />

Bordetella pertussis PCR<br />

For hospitalised patients < 1 year old ONLY<br />

For patients > 1 year old<br />

URT swab, NPA, tracheal aspirate,<br />

sputum, BAL<br />

PHE, Colindale<br />

Micropathology Ltd, Coventry<br />

Campylobacter serology Blood Preston Microbiology Services<br />

Candida serology Clotted blood / serum Mycology Reference Centre, Leeds<br />

Coccidioides serology Clotted blood / serum Mycology Reference Laboratory, Bristol<br />

Coxiella burnetti (Q fever) Blood PHE, Porton Down<br />

Darunavir levels Blood Lab21 Ltd, Cambridge<br />

Dimorphic fungi Clotted blood / serum Mycology Reference Laboratory, Bristol<br />

Diph<strong>the</strong>ria antibody levels Clotted blood / serum Vaccine Evaluation Unit, Manchester<br />

E coli serology Clotted blood / serum PHE, Colindale<br />

Galactomannan antigen Clotted blood / serum Mycology Reference Laboratory, Bristol<br />

Gancyclovir levels Clotted blood / serum Regional Antimicrobial Reference Laboratory, Bristol<br />

H ducreyii Swab for molecular testing PHE, Colindale<br />

H influenzae antibody levels Clotted blood / serum Vaccine Evaluation Unit, Manchester<br />

Histoplasma serology Clotted blood / serum Mycology Reference Laboratory, Bristol<br />

JC virus antibody Clotted blood / serum PHE, Colindale<br />

Leptospira Clotted blood / serum Leptospira Reference Unit, Hereford


This is a CONTROLLED document.<br />

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.<br />

VIRUS / AGENT / TESTS SPECIMEN REFERENCE LABORATORY<br />

Meningococcal antibody Clotted blood / serum Vaccine Evaluation Unit, Manchester<br />

Meningococcal PCR EDTA whole blood Meningococcal Reference Unit, Manchester<br />

Paracoccidiodes serology Clotted blood / serum Mycology Reference Laboratory, Bristol<br />

Pneumococcal antibody Clotted blood / serum Vaccine Evaluation Unit, Manchester<br />

Pneumococcal PCR EDTA whole blood Meningococcal Reference Unit, Manchester<br />

Rabies serology Blood Animal Health & Vet Labs Agency, Weybridge<br />

Rickettsial serology Blood PHE, Porton Down<br />

Salmonella serology Clotted blood / serum PHE, Colindale<br />

Staphylococcal antibodies Blood PHE Colindale<br />

Streptococcal antibodies Blood PHE Colindale<br />

Tetanus antibody level Clotted blood / serum Vaccine Evaluation Unit, Manchester<br />

VHF specimens (following a discussion with<br />

<strong>the</strong> on-call Virologist)<br />

EDTA whole blood<br />

PHE, Porton Down<br />

Whipples PCR EDTA blood / CSF Camelia Botnar Laboratories, GOSH<br />

Yersinia serology Clotted blood / serum PHE, Colindale

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