SERION ELISA classic Cytomegalovirus IgG / IgM - virion\serion

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SERION ELISA classic
Cytomegalovirus IgG / IgM
serion
The SERION ELISA classic Cytomegalovirus IgG and IgM tests are qualitative and quantitative
immunoassays for the detection of human antibodies directed against Cytomegalovirus in
serum or plasma. The SERION ELISA classic Cytomegalovirus IgM is recommended for the
detection of acute infections. The SERION ELISA classic Cytomegalovirus IgG test allows for
the determination of immune status as well as for the detection of intrathecally produced
IgG antibodies for CSF diagnostics. Furthermore, the SERION ELISA classic Cytomegalovirus
IgG test allows for determination of IgG antibody avidity, by using the corresponding avidity
reagent, in order to differentiate between acute and past infections.
Micrograph of a pneumocyte infected with Cytomegalovirus
(Source: CDC, Centers for Disease
Control and Prevention, United States Department
of Health and Human Services)
multianalyt TM
Pathogen
Cytomegalovirus (CMV) is a DNA virus and a member of the
Human Herpesvirus group. Primary infection may result from
contact with saliva, genital secretions, urine and breast milk of
infected persons, as well as transplacentally or iatrogenically
(transfusions, transplantations).
Disease
Primary infections are usually asymptomatic. Clinical manifestations
vary considerably depending on age and immunocompetence
ranging from localized infections to generalized
disease. Significant clinical disease or death may follow infection
of immuncompromized individuals. Reactivation in
immunocompetent adults and concomitant secretion of the
virus is usually asymptomatic. In immuncompromized patients
reactivation of CMV infection may result in clinically
severe disease. CMV infection is the major cause of complications
in iatrogenic immunsuppression after organ transplantation
and in HIV infected persons.

CMV infection is the most frequent congenital and postnatal
infection. Primary as well as reactivated infections of
pregnant women may result in foetopathy. The risk of fetal
damage is higher in case of primary infections than during
reactivations.
Diagnosis
The diagnosis of a CMV infection is occured by clinical symptoms
and medical examination. For serological diagnosis immunoglobulin
specific ELISA and, when necessary, tests for
avidity determination are recommended.
SERION ELISA classic Cytomegalovirus
For the validation of SERION ELSA classic Cytomegalovirus
IgG and IgM 331 serum samples from patients (pregnant
women, patients undergoing transplantation, patients with
HSV, VZV, HHV 6, EBV, Rubella Virus and Toxoplasma infection)
were analyzed in comparison to commercially available
ELISA. Sera classified as borderline were not included in the
calculation of sensitivity and specificity.
Highlights of SERION ELISA classic Cytomegalovirus IgG/IgM
● Use of an inactivated Cytomegalovirus preparation (Strain Towne)
● Sensitive IgM detection as an initial test for the diagnosis of acute infections, particularly during pregnancy
● Demonstration of IgG antibody activity for determination of immune status with results expressed in
PEI-U/ml referenced to the national CMV IgG reference serum of the Paul-Ehrlich-Institute (Germany)
● No significant cross-reactivities with antibodies against other Herpes Viruses, Rubella Virus or Toxoplasma
● Detection of intrathecally synthesized IgG antibodies for CSF diagnostics
● Differentiation of acute from past infections by determination of IgG antibody avidity
using the corresponding avidity reagent
● Sensitive IgM detection in DBS for demonstration of infections in neonates
Order Information
SERION ELISA classic Cytomegalovirus IgG Order Nr.: ESR 109 G
SERION ELISA classic Cytomegalovirus IgM Order Nr.: ESR 109 M
SERION ELISA control Cytomegalovirus IgG Order Nr.: C 109 G
SERION ELISA control Cytomegalovirus IgM Order Nr.: C 109 M
SERION ELISA avidity reagent Cytomegalovirus IgG Order Nr.: B 109 AVID
SERION ELISA avidity control Cytomegalovirus IgG Order Nr.: BR 109 AVID
Please visit our website www.virion-serion.com for more information on our SERION ELISA classic products.
Institut Virion\Serion GmbH
Serion Immundiagnostica GmbH
Friedrich-Bergius-Ring 19
97076 Würzburg, Germany
Sensitivity and Specificity
SERION ELISA classic Sensitivity Specificity
Cytomegalovirus IgG 99.0 % > 99 %
Cytomegalovirus IgM > 99 % 92.0 %
Precision
SERION ELISA classic Cytomegalovirus IgG
sample Mean
value
OD
Intraassay
CV (%)
(n=20)
Tel.: +49 (0)931 3045-222
Fax: +49 (0)931 3045-100
dialog@virion-serion.de
www.virion-serion.com
Mean
value
OD
Interassay
CV (%)
(n=10)
positive 0.440 3.1 0.440 3.1
positive 1.187 2.3 1.187 2.3
strong positive 1.606 2.4 1.606 2.4
SERION ELISA classic Cytomegalovirus IgM
sample Mean
value
OD
Intraassay
CV (%)
(n=20)
Mean
value
OD
Interassay
CV (%)
(n=10)
positive 0.718 3.1 0,824 3.1
positive 1.136 1.8 1.270 2.4
strong positive 1.709 1.9 1.793 2.3
Institut Virion\Serion GmbH, V5.13/01