FDA grants EUA for instrument-free RT-PCR COVID-19 test

Sept. 14, 2021

The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for an instrument-free, reverse transcription (RT)-polymerase chain reaction (PCR) COVID-19 that can be used for pooled testing of up to five samples.

From Visby Medical, based in San Jose, CA, the new FDA EUA, which extends testing with the system to pooled samples, applies to laboratories certified to perform high complexity testing according to the requirements of the Clinical Laboratory Improvement Amendments (CLIA), the company said in a news release.

The FDA authorization also extends the previous EUA for single patient sample testing at the point of care for the palm-sized, instrument-free PCR technology that returns results in less than 30 minutes.

Visby’s COVID-19 test pooling protocol enables high-complexity clinical laboratories to combine up to five patient samples into a single device for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. A positive result triggers all five samples to be re-tested individually to determine which patient or patients are infected.

Originally developed for sexually transmitted infections, the company’s FDA-cleared, CLIA-waived Sexual Health Click Test for women returns accurate results within 28 minutes.

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