OPTI SARS-CoV-2 RT-PCR Test
OPTI Medical Systems has received US FDA Emergency Use Authorization and CE mark for its OPTI SARS-CoV-2 RT-PCR Test for detection of the virus causing COVID-19.
The OPTI SARS-CoV-2 RT-PCR Test is based on real-time reverse transcription polymerase chain reaction (RT-PCR), which provides detection of the viral RNA in the sample. The test can be used on both individual samples as well as in pools of 5 samples for screening purposes. It is designed for the detection of SARS-CoV-2 RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and other upper respiratory sample types.
Results are available as fast as 2–3.5 hours including RNA extraction, and the test can be used with commonly available PCR instruments and extraction methods. The test has a high sensitivity with a limit of detection of 0.9 copies/ul.
IDEXX Laboratories, the parent of OPTI Medical Systems, has extensive expertise in PCR test development and manufacturing.
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. The manual protocol minimizes instrument investments.
PCR product inserts
The OPTI SARS-CoV-2 RT-PCR Test 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.
This CE mark certification represents OPTI Medical Systems’ assurance that its test complies with the European Union’s In Vitro Diagnostic Directive, which applies to products that are manufactured in or designed to be sold in the European Economic Area* and Switzerland.
*The European Economic Area includes the European Union (Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden) and the following countries: Iceland, Liechtenstein, Norway, and United Kingdom.