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

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

Both the submitted device and predicate use real-time PCR amplification technology with different reporter dyes for target and control detection. The cobas liat delivers results in approximately 15 minutes compared to the Panther Fusion's ~2.5 hours. Both employ sample processing controls (internal control), positive and negative controls, and accept nasopharyngeal and anterior nasal swab specimens. The submitted device uses multiple approved collection kits (Copan, BD, Remel with various transport media and saline) versus the predicate's limited kit options.

Not stated in this summary.

The devices share identical intended use (simultaneous qualitative detection and differentiation of SARS-CoV-2, Flu A/B, and RSV), same regulatory classification (21 CFR 866.3981, product code QOF), specimen types (NPS and ANS), and analytes (RNA targets). Both employ real-time PCR with internal controls and similar detection chemistry using reporter dyes. Clinical performance studies demonstrated high concordance: NPS SARS-CoV-2 94.5% PPA/97.6% NPA, influenza A/B and RSV 100% PPA/99%+ NPA. Analytical studies showed no cross-reactivity, microbial interference, or competitive inhibition across the four targets at relevant concentrations. The faster turnaround time (~15 minutes vs. ~2.5 hours) represents an improvement in the same intended use rather than a fundamental change in technology or performance characteristics.