The COV-19 IDx® + Flu A/B Assay involves extraction of SARS-CoV-2, influenza A (Flu A), and influenza B (Flu B) nucleic acid from a single respiratory specimen, followed by reverse transcription (RT) of viral RNA to cDNA and amplification using a multiplex, real-time RT PCR method. The RNase P gene, which is readily available in all human samples, is monitored during PCR amplification to ensure proper specimen collection, and optimal extraction and assay performance.
Disclaimer: This test was developed, and its performance characteristics determined by Ipsum Diagnostics LLC. This test is not cleared or approved for diagnostic use by U.S. Food and Drug Administration. The FDA has determined that such clearance and approval is not required.
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, Influenza A, or Influenza B infection and should not be used as the sole basis for patient management decisions.