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The page below is a sample from the LabCE course Zika Virus: Overview and Laboratory Testing. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Information for Laboratories: Diagnostic Tests and Emergency Use Authorization (EUA)

Although in the past, Zika virus testing in the US has been mainly performed by the CDC and in various public health laboratories, there has recently been an increase in the number of commercial and hospital-based laboratories that have received the FDA’s EUA for the detection of Zika virus in serum and urine. Most of these EUA approvals have been for molecular tests (NATs) that identify Zika virus RNA. Most of these NATs employ the rRT-PCR method. The development of serological assays for Zika virus-reactive antibodies have been slower than that for molecular assays, due to cross-reactivity with antibodies to other similar flaviviruses. In addition, it is somewhat difficult to develop serological tests that are simple to perform and that will detect the Zika antibodies while maintaining a high level of specificity with an acceptable level of sensitivity.
Emergency Use Authorization (EUA): On February 26, 2016, the Secretary of Health and Human Services (HHS) declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for the detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued. To date, EUA has been issued for at least 15 Zika virus tests. Most of these approvals have been for nucleic acid tests (NATs) for the Zika virus RNA with many of these tests employing the rRT-PCR method.
For each of the designated EUA Zika tests, the FDA issues a fact sheet for healthcare providers. The fact sheet (available on the website) contains the following information:
  • Names the test kit or specific test approved by the FDA for EUA for the detection of Zika virus in human serum and/or urine with specified instruments. The FDA usually describes whether the EUA test is approved for detection of Zika virus RNA or IgM antibodies.
  • Indicates that testing should be conducted only on specimens from individuals meeting the CDC's Zika clinical and epidemiological criteria for testing and should be performed by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 to perform high complexity tests, or by similarly qualified, non-US laboratories.
  • Issues data submitted to the FDA by the kit manufacturer to justify the emergency use of the tests for the detection of Zika virus and/or diagnosis of Zika virus infection.
  • Gives a fact sheet typically related to (1) when the EUA test should be performed, (2) how specimens should be collected with appropriate infection control precautions and according to the manufacturer’s instructions, and (3) details on the interpretation and significance of a positive or negative test result.
For more details on EUA-issued diagnostic tests, refer to the following FDA link for a current list of assays and the associated letters of authorization, fact sheets, and product labeling: