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FDA Grants Emergency Use Authorization for DiaCarta Multiplex Coronavirus Test

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for DiaCarta's QuantiVirus SARS-CoV-2 Multiplex Test Kit.

The test is designed to detect the SARS-CoV-2 Orf1ab gene in upper respiratory specimens and sputum, according to Richmond, California-based DiaCarta. Nucleic acid purification is performed using either MGI Tech's MGIEasy Magnetic Beads Virus DBA/RNA Extraction Kit or Thermo Fisher Scientific's PureLink Viral RNA/DNA Mini Kit, and the test runs on Thermo Fisher's Applied Biosystems QuantStudio 5 RT-PCR instrument or Bio-Rad's CXF384 RT-PCR system.

The test may be used by any lab CLIA-certified to perform high-complexity tests.

In April, DiaCarta said it received EUA for its QuantiVirus SARS-CoV-2 Test Kit, which detects the virus' Orf1ab, N, and E genes.