cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

The cobas liat SARS-CoV-2 & Influenza A/B v2 is an automated rapid multiplex real-time RT-PCR test that simultaneously detects and differentiates SARS-CoV-2, influenza A, and influenza B nucleic acids from nasopharyngeal and anterior nasal swab specimens. It is intended to aid in the differential diagnosis of these respiratory infections in symptomatic individuals.

Both the submitted device and predicate use real-time RT-PCR amplification with fluorescent detection chemistry and include internal controls. The key difference is turnaround time: the submitted device delivers results in approximately 15 minutes versus 2.5 hours for the predicate. Both detect the same three viral targets (SARS-CoV-2, influenza A/B) and accept the same specimen types (NPS and ANS).

Not stated in this summary.

The devices share the same regulatory classification (21 CFR 866.3981), product code (QOF), intended use, specimen types, analytes, and detection technology. The submitted device demonstrates analytical performance (sensitivity, specificity, reproducibility, no cross-reactivity or interference) comparable to or exceeding the predicate. Clinical concordance studies show 94.5–100% positive percent agreement and 97.2–99.5% negative percent agreement across both specimen types and all three targets, supporting functional equivalence despite the faster result time.