Opti Medical Systems, Roswell, Ga, a subsidiary of Idexx Laboratories, Westbrook, Maine, has received FDA emergency use authorization for the Opti SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes covid-19. Announcement of the agency’s authorization follows earlier validation of the test by the Pasteur Institute.
“Opti Medical Systems, Idexx’s medical diagnostics business, can now support critical medical covid-19 testing efforts, enabled by Idexx’s extensive expertise in PCR test development and manufacturing,” says Olivier te Boekhorst, corporate vice president and general manager of Opti Medical Systems. “We have validated the Opti SARS-CoV-2 RT-PCR test kit with existing laboratory customers, and are advancing our initial distribution to select certified laboratories using common PCR platforms.”
The Opti SARS-CoV-2 RT-PCR test kit is based on real-time reverse transcription polymerase chain reaction designed for the detection of SARS-CoV-2 RNA extracted from bronchoalveolar lavage, nasopharyngeal swabs, oropharyngeal swabs, and sputum samples. The test kit has been validated on commonly available qPCR instruments, and provides results in approximately 2 to 3.5 hours.
For more information, visit Opti Medical Systems.