For Use Only Under the FDAs Emergency Use Authorization – Rx ONLY
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.
Assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Reactive results are not definitive for the diagnosis of Zika virus infection. False positive results are possible in patients with a history of infection with other Flaviviruses. 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. Within the United States and its territories, laboratories are required to report presumptive positive results to the appropriate public health authorities.
Results of this test cannot be used as the sole basis of patient management decisions and must be combined with clinical observations, patient history, epidemiological information, and other laboratory evidences. Zika IgM levels over the course of illness are not well characterized. IgM levels are variable, may be detectable near day four post onset of symptoms and persist up to approximately 12 weeks following initial infection.
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.
The ZIKV Detect™ IgM Capture ELISA is intended for use by trained laboratory personnel who are proficient in performing and interpreting immunoassays.The ZIKV Detect™ IgM Capture ELISA is only for use under the FDAs Emergency Use Authorization.
PROTOCOL USE LIMITATIONS
The ZIKV Detect™ IgM Capture ELISA described here has not been extensively tested with clinical specimens. Modifications of these assays (i.e., use of platforms or chemistries other than those described) are not permitted
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens; and
- 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.