Opti Medical Systems gets FDA EUA status for Covid-19 PCR test kit

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IDEXX Laboratories subsidiary Opti Medical Systems has secured emergency use authorisation (EUA) from the US FDA for its SARS-CoV-2 RT-PCR laboratory test kit. The Opti SARS-CoV-2 RT-PCR laboratory test kit has been designed to detect SARS-CoV-2, the virus responsible for Covid-19 disease.

The Institut  Pasteur of France has already validated the Corona virus test. IDEXX Laboratories president and CEO Jay Mazelsky said: “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.”

The Opti SARS-CoV-2 RT-PCR test kit is said to be based on real-time reverse transcription polymerase chain reaction (RT-PCR), which helps to detect viral RNA in the sample.

It will help detect SARS-CoV-2 RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage and sputum samples. The commonly available qPCR instruments are suitable to run the Opti SARS-CoV-2 RT-PCR test

The test can identify human RNase P as an internal sample control and endogenous nucleic acid to control for sample addition, extraction, and amplification.

The Opti test, which can be run on commonly available qPCR instruments, delivers results between two and 3.5 hours. Opti Medical Systems general manager and corporate vice president Olivier te Boekhorst said: “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.

“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.”

Recently, Roche secured EUA status from the US FDA for its new Elecsys Anti-SARS-CoV-2 antibody test. It is an immunoassay for the in-vitro qualitative detection of antibodies to severe acute SARS-CoV-2 in human serum and plasma.