COVID-19 test kit 99-57004

SARS-COV-2nasopharyngealoral fluid

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, collected from any individual, including from individuals without symptoms or other reasons to suspect COVID-19 infection. A complete PCR testing solution High sensitivity according to internal and external validations. Extraction-free protocol available with the OPTI Rapid Lysis Buffer. Low limit of detection enables pooling without reducing detection rate. Detection of two different targets in the N coding region, avoiding the S mutations found in recent variants. Monitoring of new viral strains and mutations to ensure the test detects all new strains. Secure supply in an uncertain situation. Combine this test with the OPTI Rapid Lysis Buffer or the OPTI DNA/RNA Magnetic Bead Kit for a complete solution. Performance The OPTI SARS-CoV-2 RT-PCR Test has a high sensitivity with a limit of detection of 0.36 copies/µl. It can be used with commonly available PCR instruments and extraction methods, and results are available as fast as 2 hours including RNA extraction. The test detects SARS-CoV-2 variants of concern based on the sequences submitted to the GISAID database.