cobas liat SARS-CoV-2 v2 nucleic acid test

The cobas liat SARS-CoV-2 v2 is an automated real-time RT-PCR test that detects SARS-CoV-2 nucleic acids in nasal and nasopharyngeal swab specimens from both symptomatic and asymptomatic individuals. It is intended as an aid in COVID-19 diagnosis when used with clinical and epidemiological information.

The device uses real-time PCR amplification with automated sample purification and detection on the cobas liat analyzer, targeting both ORF1 a/b and membrane protein genes. Key difference from predicate: uses membrane protein gene target instead of nucleocapsid protein gene. Controls include an internal sample processing control plus positive and negative external controls.

Not stated in this summary.

The predicate device (K223783) is substantially equivalent because both use identical instrumentation (cobas liat System), same amplification technology (real-time PCR), same detection chemistry, same specimen types (NPS and ANS), and nearly identical indications for use. Although the v2 targets the membrane protein gene instead of nucleocapsid protein, in silico analysis shows 99.9% detection coverage across major SARS-CoV-2 sequence databases, clinical performance shows PPA/NPA of 94.5%/97.6% (symptomatic NPS) and 86.1%/97.9% (asymptomatic NPS), and all 10 tested variants detected at 3x LoD.