WESTBROOK, Maine — OPTI Medical Systems, Inc., a subsidiary of Westbrook-based IDEXX Laboratories, Inc., announced Thursday that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization for its coronavirus test.
The OPTI® SARS-CoV-2 RT-PCR laboratory test kit is aimed at the detection of coronavirus, the virus that causes COVID-19. This announcement follows earlier validation of the test by the Institut Pasteur of France.
The test kit is based on real-time reverse transcription polymerase chain reaction, which provides detection of the viral RNA in the sample. It's designed to detect the virus based on extractions from nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage and sputum samples.
According to IDEXX, the test kit provides results in approximately 2–3.5 hours and has been validated on commonly available qPCR instruments.
“This advancement is a true reflection of our talented global team coming together and leveraging innovation across our organization to bring a diagnostic solution to support COVID-19 testing during this unprecedented pandemic,” Jay Mazelsky, President and Chief Executive Officer of IDEXX Laboratories, said.
The test kit was developed by utilizing the Emergency Use Authorization process outlined by the FDA in March. 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 OPTI SARS-CoV-2 RT-PCR Test has an easy workflow with simple pipetting steps, making high throughput testing easy for medical technologists to perform. This minimizes errors and allows for effortless scalability,” Dr. Hayley Webber, Technical Director of Molecular Diagnostics at NorDx Laboratories of Scarborough, Maine, said.