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xMAP® MultiFLEX™ ZIKA RNA ASSAY

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EUA – In Vitro Diagnostic Use Under Emergency Use Authorization. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization 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.

MultiFLEX is a trademark of GenArraytion™ Inc.

Intended Use (US-IVD):

The xMAP® MultiFLEX™ Zika RNA Assay test is a RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., 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 epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to qualified laboratories that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

Test results are for the identification of Zika viral RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current Zika virus infection.  Laboratories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The xMAP® MultiFLEX™ Zika RNA Assay test is intended for use by trained clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the xMAP® MultiFLEX™ Zika RNA Assay. The test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The xMAP® MultiFLEX™ Zika RNA Assay is indicated for use on Luminex® IVD xMAP® instruments (MAGPIX® or Luminex® 200™).