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InBios International Gets FDA Emergency Use Authorization for SARS-CoV-2 Kit

NEW YORK – Infectious disease diagnostic firm InBios International announced Wednesday its Smart Detect SARS-CoV-2 rRT-PCR Kit has received Emergency Use Authorization from the US Food and Drug Administration.

The real-time RT-PCR test detects SARS-CoV-2 nucleic acid in nasopharyngeal, anterior nasal, and mid-turbinate nasal swabs and delivers results in about four hours, the Seattle-based company said. The test has been validated on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx Real-Time PCR instrument and Bio-Rad Laboratories' CFX96 Touch Real-Time PCR Detection system. 

The RT-PCR test is available immediately, and InBios said it is planning to launch more tests in the next few weeks, including a serology kit for antibody detection of SARS-CoV-2.