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Zika RT-PCR Serum with Reflex to Zika IgM Serum

Test Code: 354810
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Clinical Utility

RT-PCR

Zika Virus Real-time RT-PCR test is a real-time RT-PCR test intended for the qualitative detection of RNA from Zika virus in human plasma, serum or urine (collected alongside a patient matched serum or plasma specimen). Specimens are collected from individuals meeting Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or 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 epidemiologic criteria for which Zika virus testing may be indicated). Health care providers are strongly encouraged to collect serum/plasma specimens alongside other specimen types to provide additional opportunities for diagnosing Zika virus infection in cases when PCR tests are negative.

IgM

The ZIKV Detect™ 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

RT-PCR

Extraction of Zika virus nucleic acid from specimen, followed by combined reverse transcription of viral RNA and PCR amplification using real-time, RT-PCR methods. An internal control is added to ensure that extraction was performed correctly and that the RT-PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

This assay will automatically reflex to Zika Virus IgM Serum testing with a “Not Detected” Zika Virus RT-PCR result.

IgM

The ZIKV Detect™ IgM Capture ELISA is an enzyme linked capture immunoassay for the detection of human IgM antibodies targeting the ZIKV envelope glycoproteins. The ZIKV Detect™ IgM Capture ELISA has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

RT-PCR

Zika Virus RT-PCR does not cross-react with other viruses in the Flaviviridae family (including Dengue virus, Japanese encephalitis virus, West Nile virus and St. Louis encephalitis virus) or with other viruses known to cause similar clinical symptoms such as Chikungunya virus.

IgM

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 Detect™ IgM Capture ELISA.

Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday. Additional 8-48 hours when reflex testing is required.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
serum 354810 87662, 86794 Yes

2 mL (min. 1 mL)

RT-PCR: Detected/Not Detected

IgM: 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.

  • Collect 4-5 mL whole blood in red top tube.
  • Centrifuge and transfer 2 mL serum to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 4 days of collection.
Shipping

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

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 Viracor 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. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

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