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Cytomegalovirus (CMV) IgG EIA

Test Code: 30811

Please contact Client Services to set up a Pre-transplant account to order this assay.

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Clinical Utility

For the detection of human IgG antibodies to cytomegalovirus in human serum by enzyme immunoassay, as an aid in the determination of acute or reactivated infection with CMV. When used as a qualitative test, CMV IgG EIA aids in the assessment of the patient's immunological response to CMV. These reagents have not received FDA clearance for use in testing blood or plasma donors.

About Cytomegalovirus

Cytomegalovirus (CMV) is the causative agent of cytomegalic inclusion disease, a generalized infection of infants caused by intrauterine or early post natal infection. The disease may cause sever congenital abnormalities, such as microcephaly, motor disability, and mental retardation in infants.1-3 Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome. Subclinical infection may occur in adults.4 CMV infection can be transmitted to immunodeficient or immunocompromised individuals, as a result of blood transfusion5 or organ transplantation.6

Serological tests, such as the CMV IgG EIA test, which detect the presence of CMV IgG antibodies, can aid in the diagnosis of diseases caused by cytomegalovirus. Test results are obtained after one and one-half hours incubation time. They are objective and normalized as index values, permitting uniformity or reporting.

Procedure

Diluted samples are incubated in antigen-coated wells. Absorbents have been included in the Diluent to neutralize the effects of rheumatoid factor and anti-CMV IgG antibody. CMV antibodies (if present) are immobilized I the wells. Residual sample is eliminated by washing and raining, and conjugate (enzyme-labeled antibodies to human IgM) is added and incubated. If IgM antibodies to CMV are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme-labeled substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end 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
Serum 30811 86644 Yes

100 µL (min 25 µL)

Qualitative

  • Collect whole blood in a red top tube. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped at ambient or refrigerated temperature, received within 3 days.
  • If not shipping in original container, centrifuge and transfer 100 µL (min 25 µL) serum to screw top tube. Specimens shipped at ambient temperature must be received within 3 days, refrigerated within 3 days of collection, or frozen.
Shipping

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.

Causes for Rejection

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.

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