This test has not been FDA cleared or approved. In the USA this test can be adopted in clinical diagnostics laboratories as an LDT according to local state guidelines. The test can be used for RUO/Informational purposes. The test is currently pending for CE IVD certification.

This test detects specifically SARS-CoV-2 and cannot be used to detect other viruses or pathogens.

Please refer to the Interpretation of Results, the Appendix, and the Troubleshooting Guide sections in our Quick SARS-CoV-2 Multiplex Kit protocol.

Sometimes aberrant qPCR signal are observed. Please refer to the Interpretation of Results, the Appendix, and the Troubleshooting Guide sections in our Quick SARS-CoV-2 Multiplex Kit protocol.

This may indicate incorrect plate set-up or a contamination in the No-Template Control or in the 2X CV Mix. We recommend repeating the test, and if the problem persists to use a new aliquot of reagents.

If using RT-PCR instruments different than the CFX96 Touch from Bio-Rad, this problem can be solved by adjusting the RT-PCR parameters (e.g. baseline threshold, temperature ramp, ...). This problem may also indicate incorrect plate set up of the compromise of Quick SARS-CoV-2 reagents.

With a limit of detection(LoD) as low as 10 GEC/reaction the Quick SARS-CoV-2 Multiplex Kit outperforms most of the SARS-CoV-2 molecular tests present on the market. In addition, the detection of a host target (human Rnase P) allow the identification of insufficient samples, which other tests may classify as negative; this further reduce the chances of the false negative results.