cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems

The cobas Respiratory 4-flex is an automated multiplex nucleic acid test using real-time PCR technology for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) in nasopharyngeal swab specimens from patients with respiratory tract infection symptoms. Results aid in differential diagnosis but should not be used as the sole basis for clinical decisions.

The device uses PCR amplification with TaqMan probes and fluorescent dyes, employing Roche's temperature-assisted generation of signal (TAGS) technology to differentiate up to three targets per fluorescence channel. It includes dUTP and AmpErase enzyme for contamination control, automated sample preparation on cobas 5800/6800/8800 systems, and an internal RNA control. The predicate device (BioFire RP2.1) uses two-step nested multiplex PCR with endpoint melting curve analysis and detects 21 organisms versus cobas 4-flex's four targets.

Not stated in this summary.

Both devices are regulated under 21 CFR 866.3981 as Class II multi-target respiratory nucleic acid tests with identical product codes (QOF) and intended uses for detecting respiratory viral pathogens in nasopharyngeal specimens. Analytical performance studies demonstrated comparable limit of detection, precision, reproducibility, analytical specificity, and absence of cross-contamination. Clinical studies comparing cobas Respiratory 4-flex against FDA-cleared comparators showed positive and negative percent agreements of 89.7–100% and 98.5–100% respectively across all four targets in 4,341 prospective specimens and 659–770 retrospective specimens. Equivalent performance was demonstrated between cobas 6800/8800 and 5800 instrument platforms.