Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

The Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel is a multiplex real-time reverse transcription PCR (RT-PCR) test that qualitatively detects and differentiates SARS-CoV-2, influenza A and B viruses, and respiratory syncytial virus (RSV) from nasopharyngeal and anterior nasal swab specimens. The test is intended to aid in the differential diagnosis of these respiratory infections in patients exhibiting signs and symptoms of respiratory tract infection.

The device uses real-time RT-PCR technology with gene-specific primers and probes targeting three SARS-CoV-2 genes (Orf1a, Orf1b, N), two influenza A genes (PB1, M), two influenza B genes (M, NS), and three RSV genes (NP, M, L protein), plus RNase P as an internal control. It differs from the predicate BioFire RP2.1 in specimen types (includes anterior nasal swabs), instrumentation (QuantStudio 5 Dx instead of FilmArray systems), and sample prep methodology (external magnetic bead-based kit versus integrated pouch system).

Not stated in this summary. The document references CLSI EP24-A2 for Receiver Operating Characteristic analysis but does not cite formal consensus standards such as ISO, IEC, or ASTM.

Substantial equivalence is based on identical intended use (detection and differentiation of the same four respiratory viral targets), same analyte type (RNA), same technological principle (real-time RT-PCR), same specimen type foundation (nasopharyngeal swabs, with anterior nasal as additional type), and automated test interpretation. Clinical performance data from 1,909 prospective and enriched subjects demonstrated high positive and negative percent agreement with the predicate comparator across both specimen types, with PPA ≥93.8% and NPA ≥99.36% for all targets, supporting that the device performs substantially similarly to the predicate despite differences in instrumentation and workflow components.