The COV-19 IDx® Assay involves extraction of SARS-CoV-2 viral nucleic acid from respiratory specimens, followed by reverse transcription of viral RNA to cDNA and subsequent amplification of SARS-CoV-2 N1 gene using real-time PCR. An internal control, the RNase P gene target, which is readily available in all respiratory specimens is also targeted for amplification to ensure proper specimen collection, and optimal extraction performance, and that the RT-PCR reaction was not inhibited.
Disclaimer: This test was developed and its performance characteristics determined by Ipsum Diagnostics LLC. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. This test is used for clinical purposes and should not be regarded as investigational or for research. This test is authorized under an FDA Emergency Use Authorization (EUA) for use by Ipsum Diagnostics, LLC. This test is authorized only for the detection of RNA from SARS CoV-2 virus and diagnosis of SARS CoV-2 virus infection, not for any other viruses or pathogens.
This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The information contained in the test reports are intended to be interpreted by a licensed health care professional. A positive result does not rule out bacterial infection or co-infection with other viruses. A negative result does not rule out the possibility of SARS-CoV-2 and should not be used as the sole basis for patient management decisions.
For additional information please find reference links on the Covid Patient Fact Sheet
For additional information please find reference links on the Covid Provider Fact Sheet