Alinity m Resp-4-Plex

The Alinity m Resp-4-Plex is a multiplexed real-time RT-PCR assay for automated 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. The assay is intended to aid in differential diagnosis when used with other clinical and epidemiological information.

The device uses the Alinity m System platform with automated sample preparation via magnetic microparticle technology, real-time PCR amplification and detection with analyte-specific fluorescent probes, and targets two SARS-CoV-2 genes (RdRp and N), the matrix gene for flu A and RSV, and the nonstructural 1 gene for flu B. Specimen collection is limited to BD UVT and Copan UTM media, compared to the predicate which also accepts Remel MicroTest and Hardy Diagnostics media.

Not stated in this summary.

Substantial equivalence is established through identical intended use (qualitative detection and differentiation of the same four respiratory viruses in nasopharyngeal swabs for differential diagnosis), identical assay principle (multiplexed real-time RT-PCR), identical specimen types, identical control strategy (positive, negative, and internal controls), and automated closed-system processing with no manual transfer steps. Analytical performance data (limit of detection, inclusivity, precision, reproducibility, cross-reactivity, and carryover) and clinical performance data (positive percent agreement 95.3%–100% and negative percent agreement 96.0%–100.0% across all analytes) demonstrate performance comparable to the predicate device, and identified differences in supported transport media do not raise new safety or effectiveness concerns.