Opti Medical gets EUA for COVID-19 molecular diagnostic

2020 05 07 22 45 7209 Lab Tech Coronavirus Sample 400

Opti Medical Systems has received emergency use authorization (EUA) from the U.S. Food and Drug Administration for its molecular novel coronavirus laboratory test kit.

The Opti SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) test kit uses real-time RT-PCR technology to detect viral RNA from nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage and sputum samples. It also uses detection of human ribonuclease P (RNase P) as a sample control and endogenous nucleic acid as a control for sample addition, extraction, and amplification.

The test runs on commonly used PCR instruments and can provide results in less than four hours, according to the company.

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