On May 7, 2020, OPTI Medical Systems, an IDEXX Laboratories subsidiary announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19. This announcement followed earlier validation of the test by the Institut Pasteur of France.

The OPTI SARS-CoV-2 RT-PCR test kit is based on real-time reverse transcription polymerase chain reaction (RT-PCR), which provides detection of the viral RNA in the sample. It is designed for the detection of SARS-CoV-2 RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage and sputum samples. The OPTI SARS-CoV-2 RT-PCR test kit detects human RNase P as an internal sample control and endogenous nucleic acid to control for sample addition, extraction and amplification. The test kit provides results in approximately 2–3.5 hours and has been validated on commonly available qPCR instruments.

The OPTI SARS-CoV-2 RT-PCR test kit was developed by utilizing the EUA process outlined by the FDA in March 2020. Use in the United States is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a (CLIA), to perform high complexity tests to assist physicians in the diagnosis of COVID-19. The test kit is not FDA cleared or approved, CLIA waived, subject to an approved investigational device exemption or intended for home use.