Vela Diagnostics Receives EUA for Zika MDx
News Sep 27, 2016
Vela Diagnostics has announced that the Sentosa® SA ZIKV RT-PCR Test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The real-time PCR test by Vela Diagnostics enables the qualitative detection of RNA from Zika virus in human specimens and is available 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.
The test is authorized for use with serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and/or epidemiological criteria.
Authorized to run on the automated Sentosa® SX101 real-time PCR workflow, along with the Sentosa® SX Virus Total Nucleic Acid Kit v2.0, authorized laboratories can process 22 samples per run for rapid detection of Zika virus with a turn-around time of approximately 3 hours.
• This test has not been FDA cleared or approved;
• 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; 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.