Emergency use authorization This test has been issued Emergency Use Authorization (EUA) for TaqPath Zika Virus (ZIKV) Kit, 0.1 mL Format, by the USA FDA. • This test has been authorized by the 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. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.
Intended use The TaqPath Zika Virus Kit (ZIKV) is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum and urine (collected alongside a patient-matched serum 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), by 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.
Results are for the identification of Zika virus RNA, which is generally detectable in serum and/or urine during the acute phase of infection and up to 14 days following onset of symptoms, if present. Positive results are indicative of current 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 TaqPath Zika Virus Kit (ZIKV) is intended for use by trained clinical laboratory personnel who have received specific training on the use of the TaqPath Zika Virus Kit (ZIKV) on the Applied Biosystems QuantStudio Dx Real-time PCR instrument and software system. The assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
About the kit The TaqPath Zika Virus Kit (ZIKV) is a lyophilized real-time rt-pcr assay for qualitative detection of RNA from the Zika virus in serum or urine (collected alongside a patient-matched serum specimen). This kit includes primers, probes, and one-step real-time PCR master mix for the molecular detection of Zika RNA. It also includes a primer-probe set for human PPIA (cyclophilin A) as an endogenous extraction, RT-PCR, and PCR amplification control.
Features: • Emergency Use Authorization (EUA) issued from the FDA • Lyophilized with one-step RT-PCR master mix; simply add RNA • Simple workflow for detection of Zika virus RNA from urine or serum • No cold-chain management required; ship and store at room temperature
For Use Under the Emergency Use Authorization (EUA) Only
Contents & storage
12 x 8-well strip tubes, Store at room temperature