OPTI SARS-CoV-2 RT-PCR Test Kit
OPTI Medical Systems has received US FDA Emergency Use Authorization for its OPTI SARS-CoV-2 RNA PCR Test Kit for detection of the virus causing COVID-19.
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.
Results
Results are available in approximately 2–3.5 hours including RNA extraction, and the test kit can be used with commonly available PCR instruments and extraction methods.
OPTI DNA/RNA Magnetic Bead Kit
The OPTI DNA/RNA Magnetic Bead Kit is intended for extracting RNA from respiratory samples for subsequent analysis with the OPTI SARS-CoV-2 RT-PCR Test. The extraction kit requires minimum hands-on-time (<15 minutes) when used on automated magnetic separators, such as Kingfisher™ or MagMax™ purification systems for high throughput sample processing.
Notes
The OPTI SARS CoV-2 RT-PDR test kit has been authorized by the United States Food & Drug Agency (FDA) under an Emergency Use Authorization issued by the FDA on May 6, 2020. This test has not been FDA cleared or approved, and the FDA has not determined that the test is safe or effective for the detection of SARS-CoV-2. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the U.S. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 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. The test is not intended for home use.
IDEXX Laboratories, the parent of OPTI Medical Systems, has extensive expertise in PCR test development and manufacturing.