cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

cobas® SARS-CoV-2 Qualitative is a real-time RT-PCR test for qualitative detection of SARS-CoV-2 RNA in nasopharyngeal and anterior nasal swab specimens. It is intended for use on automated cobas® 5800/6800/8800 Systems and can test both symptomatic individuals with signs of COVID-19 and asymptomatic individuals. Positive results indicate presence of SARS-CoV-2 RNA; negative results do not exclude infection and must be interpreted alongside clinical context.

The device uses fully automated sample preparation (nucleic acid extraction and purification) followed by real-time PCR amplification and detection. It employs target-specific primers for SARS-CoV-2 ORF1a/b region and a conserved E-gene region for pan-Sarbecovirus detection. Detection uses paired fluorescent reporter and quencher probes (TaqMan technology) with fluorescence resonance energy transfer (FRET), an RNA internal control for process monitoring, and an AmpErase enzyme to eliminate contaminating amplicons. Result analysis is based on PCR cycle threshold analysis.

Not stated in this summary.

The device is substantially equivalent because it shares identical technological characteristics with the predicate device (K231306): same regulation number (21 CFR 866.3981), same product code (QQX), same sample types (nasopharyngeal and anterior nasal swabs), same analyte target (SARS-CoV-2), same amplification technology (real-time PCR), same detection chemistry (TaqMan probes with FRET), and same controls and analysis methods. Clinical performance data from real-world NFL testing (100% PPA, 99.8% NPA) and the TUAH study (94.3% PPA, 99.2% NPA) demonstrate equivalent performance to the predicate. Updated in-silico analysis confirms >99.9% of SARS-CoV-2 sequences are predicted to be detected by at least one of the two targets.