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Warrior Diagnostics, InBios Nab FDA Emergency Use Authorizations for SARS-CoV-2 Assays

NEW YORK – Warrior Diagnostics and InBios International have separately received Emergency Use Authorization from the US Food and Drug Administration for their SARS-CoV-2 assays.

The FDA issued the EUA to Warrior Diagnostics' real-time RT-PCR test on Tuesday. The test is intended to be used with nasopharyngeal swab samples and amplifies and detects the N1 and N2 regions of the SARS-CoV-2 nucleocapsid gene, along with human RNase P nucleic acid. The Warrior Diagnostics SARS-CoV-2 Assay uses the same primers and probes as the US Centers for Disease Control and Prevention's diagnostic panel, which received EUA from the FDA in February.

The test uses Agilent Technologies' AriaMx Real-Time PCR System and testing will be performed at Warrior Diagnostics' high-complexity CLIA-certified lab. According to the data submitted by the Loveland, Colorado-based firm, the lowest level of plasmid DNA reliably detected by the assay was approximately 150,000 copies per milliliter. The test also had 100 percent positive agreement when tested against the Laboratory Corporation of America's RT-PCR test, which also uses the CDC's primers and probes. That test received EUA in March.  

Separately, InBios said on Thursday that its CoV-2 Detect IgG ELISA kit received EUA from the FDA. The test detects IgG antibodies in human serum and delivers results in about two hours, the firm said in a statement. No specific analyzer is required for the test and the kit demonstrated approximately 98 percent sensitivity and 99 percent specificity. In April the Seattle-based infectious disease diagnostic company received EUA for its Smart Detect SARS-CoV-2 rRT-PCR Kit.