Epstein-Barr Virus (EBV) IgM EIA
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For the qualification detection of human IgM antibodies to Epstein-Barr (EBV) viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. These reagents have not received FDA clearance for use in testing blood or plasma donors.
About Epstein-Barr Virus
This summary does not intend to imply additional performance claims other than those already indicated in the Clinical Utility section.
Epstein-Barr virus (EBV) is the etiological agent of infectious mononucleosis (IM), and has also been implicated in Burkitt's lymphoma and nasopharyngeal carcinoma.1 The designation of infectious mononucleosis classically refers to an Epstein-Barr virus-induced illness in young adults characterized by reactive blood smears, exudative pharyngitis, prominent cervical lymphadenopathy, and serologically detectable heterophile antibodies. These clinical manifestations can also be caused by a number of other pathogenic agents including cytomegalovirus, Toxoplasma gondii, rubella virus, hepatitis virus, human immunodeficiency virus (HIV), and uncommonly by drugs such as Halothane, Hydantoin, Dapasone, and Azulfidine.2-4
Diagnosis of acute EBV IM is generally confirmed by a positive heterophile antibody test. The severity of the disease, however, is not indicated by the relative titer of heterophile antibodies.5 In addition, difficulties in diagnosis arise when the heterophile antibody test is negative, or when the clinical manifestations are atypical or unusually severe.
IgG antibodies to VCA may be present early during EBV infection, but they persist indefinitely after the occurrence of clinical disease and may merely indicate EBV infection at some time in the past. IgM antibodies to VCA, on the other hand, are present in the circulation 1 to 6 weeks after the onset of EBV illness and usually disappear in 3 to 6 months. Thus the presence of VCA IgM usually suffices for the diagnosis of acute IM. Further verification may be obtained by testing for the presence of antibodies directed against the other EBV-specific antigens, early antigen and EBNA. Heterophile antibody negative sera demonstrating VCA IgM and transient levels of antibody to early antigen and considered diagnostic for acute IM. In contrast, antibodies to EBNA appear late during IM infections, and IgG antibodies to EBNA may persist for years, even for life, and are indicative of the convalescent phase of IM infection.
The EB VCA IgM EIA test is an ELISA test which utilizes a microwell format. Test results are obtained after one and one-half hours incubation time. They are objective and normalized as Index values, permitting uniformity of reporting.
Diluted samples are incubated in VCA antigen-coated wells. Absorbents have been included in the Diluent to neutralize the effects of rheumatoid factor and IgG antibody. VCA IgM antibodies (if present) are immobilized in the walls. Residual sample is eliminated by washing and draining, and conjugate (enzyme labeled antibodies to human IgM) is added and incubated. If IgM antibodies to VCA are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow and product which is read photometrically.
Test performed by VRL Eurofins, 6933 S. Revere Parkway, Centennial, CO 80112. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information.
Within 24 hours from receipt of specimen (Monday - Friday).
|Specimen Type||Order Code||CPT Code||NY Approved||Volume||Assay Range||Special Instructions|
100 µL (min 25 µL)
All specimens must be labeled with patient's name and collection date. A Viracor/VRL Eurofins Pre-Transplant test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: VRL Eurofins, 6933 S. Revere Parkway, Centennial, CO 80112.
Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.
Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on VRL Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. VRL Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.