Interpretation of real-time RT-PCR results

Technical document summarizing the criteria for interpreting results for real-time RT-PCR tests using the Flu SC2 Multiplex Assay, employed in the simultaneous detection of influenza A, influenza B, and SARS-CoV-2 viruses. It specifies the expected amplification patterns according to the combination of genetic markers (InfA, InfB, SC2, and RP) and defines the corresponding diagnostic categories: positive, negative, inconclusive, or not subtyping. It also includes guidelines for the subtyping of influenza A viruses (H1pdm09, H3, H5) and the criteria for analytical validation of the assay (logarithmic curves with a detection threshold Ct <38). The procedure for immediate notification to PAHO in cases of detection of unclassifiable variants or emerging subtypes is established.