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Cytomegalovirus (CMV) IgM EIA

Test Code: 30812

A special account is required to order pre-transplant testing. Contact Client Services or your account executive to set up a a pre-transplant account to order this assay. Specimens should not be collected until account has been created.

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Clinical Utility

For the qualitative detection of human IgM antibodies to cytomegalovirus (CMV) in human serum, by enzyme immunoassay, to aid in the diagnosis of CMV infection. A positive result is presumptive for the detection of anti-CMV IgM antibodies and presumptive for the diagnosis of acute or recent CMV infection. These reagents have not received FDA clearance for use in testing blood or plasma donors.

About CMV

Cytomegalovirus (CMV) has been identified as a major causative agent of congenital abnormalities, including mental retardation and deafness in infants infected in utero. 1,2,3 Subclinical infection may occur in adults as well as overt disease including hepatitis, pneumonitis, and cytomegalovirus induced mononucleosis.4 CMV infection can be transmitted to immunodeficient or immunosuppressed individuals as a result of blood transfusion 5 or organ transplantation.6 In summary, pregnant women, neonates, and immunocompromised individuals are at risk of developing clinically significant disease caused by CMV infection.

The diagnosis of CMV infection is frequently assisted by serological methods. The demonstration of CMV IgM antibodies is indicative of recent or current infection or, in the case of newborns, of congenital infection.

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 30812 86645 Yes

100 µL (min 25 µL)

Qualitative

  • Collect whole blood in an gold, red, or red/gray (tiger) top tube. Do not freeze whole blood.
  • Sample sent in original vacutainer tube can be shipped at ambient or refrigerated temperature, must be received within 3 days.
  • If not shipping in original container, centrifuge and transfer 100 µL (min 25 µL) serum to screw top tube. Serum shipped at ambient or refrigerated temperature must be received 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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