OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, has announced the CE mark certification in the European Union for its OPTI^® SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19.

This announcement follows earlier validation of the test by the Institut Pasteur of France as well as Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA).

Additionally, the FDA has granted EUA for the new OPTI DNA/RNA Magnetic Bead Kit for nucleic acid extraction from respiratory samples to be used with the OPTI SARS-CoV-2 RT-PCR test kit, which enables OPTI Medical Systems to provide laboratories with a complete OPTI Medical Systems-manufactured workflow solution for COVID-19 testing.

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.

For details about the test kit and OPTI DNA/RNA Magnetic Bead Kit, visit optimedical.com/products-services/C19-test.html.