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Zika Virus IgM

Test Code: 30294

Last Updated 9/7/2016

Cpt Code:

86790 (x1)

Clinical Utility

The ZIKV DetectTM IgM Capture ELISA is intended for the presumptive detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). The assay is intended for use in laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, consistent with the latest CDC guideline for the diagnosis of Zika virus infection.

Procedure

The ZIKV DetectTM IgM Capture ELISA is an enzyme linked capture immunoassay for the detection of human IgM antibodies targeting the ZIKV envelope glycoproteins. The ZIKV DetectTM IgM Capture ELISA is only for use under the FDA's Emergency Use Authorization.

Specificity

False positive results are possible in patients with a history of infection with other Flaviviruses (Dengue, West Nile, Japanese Encephalitis, and Saint Louis encephalitis (SLE)) . Confirmation of the presence of anti-Zika IgM antibodies in presumptive positive specimens requires additional testing according to the latest CDC guideline for the diagnosis of Zika virus infection.


Note: In the case of specimens originating from regions with a known West Nile virus outbreak, an FDA-cleared West Nile virus IgM assay should be run in parallel with the ZIKV DetectTM IgM Capture ELISA.

Assay Range

Presumptive Zika Positive: Presence of detectable Zika IgM antibody, possible recent infection with ZIKV. The result should be confirmed by the latest CDC guideline for the diagnosis of Zika virus infection.

Possible Zika Positive:Specimens that fall in this category may still have levels of Zika IgM antibody present in serum and follow-up testing is required; however, other confounding IgM antibodies from related flaviviruses may be present that cause this level of reactivity.

Presumptive Other Flavivirus Positive: The result should be confirmed with FDA-cleared Dengue and West Nile virus IgM devices.

Negative: Negative results do not preclude the possibility of Zika virus infection, past or present. Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes.

 

Causes For Rejection

Specimen types other than serum.

Turnaround Time

Same day (within 8-12 hours of receiving specimen), Monday through Saturday.

Shipping

Ship Monday through Friday. Label Friday shipments for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Specimen Information

Serum

NY approved. Collect 4-5 mL whole blood in red top tube, centrifuge and transfer 2 mL serum to sterile, screw top tube (minimum volume 0.5 mL) . Can be shipped on cold pack or frozen Monday through Friday. Specimens shipped at 2-8°C must be received within 48 hours of collection. If samples will not be received within 48 hours, freeze and ship on dry ice.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Viracor-IBT's 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. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

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