Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

The Xpert Xpress CoV-2 plus is a rapid, automated real-time RT-PCR test that detects SARS-CoV-2 RNA in nasopharyngeal and anterior nasal swab specimens from individuals with respiratory symptoms. It is performed on the GeneXpert Xpress System and provides results in approximately 30 minutes as an aid in COVID-19 diagnosis when used with other clinical findings.

The subject device uses the same real-time RT-PCR technology, detects the same three SARS-CoV-2 targets (E, N2, RdRP), accepts the same specimen types and transport media, produces qualitative results with the same internal controls (SPC and PCC), and achieves the same ~30-minute turnaround as the predicate. The primary difference is the platform: the subject device runs on the GeneXpert Xpress System rather than the GeneXpert Dx and GeneXpert Infinity Systems used by the predicate.

The analytical sensitivity studies followed CLSI document EP17-A2. The document cites in silico analyses against the GISAID gene database and wet-testing of 61 SARS-CoV-2 strains. Cross-reactivity testing included 62 microorganisms and reference panels (human coronaviruses, respiratory viruses, bacteria, fungi). Reproducibility was assessed using nested ANOVA for Ct values.

Substantial equivalence is established through identical intended use (COVID-19 diagnosis from NPS/NS specimens), identical assay targets and technology (three-target RT-PCR), identical specimen types and transport media, identical qualitative output format and internal controls, and demonstration of equivalent analytical performance (LoD 403 copies/mL for NPS-UTM/VTM and 462 copies/mL for NS-UTM/VTM). Clinical performance showed 98.2%–99.0% positive percent agreement and 99.1% negative percent agreement across 1,783 specimens, which is comparable to the predicate. The platform difference (GeneXpert Xpress vs. Dx/Infinity) does not alter the fundamental assay design, performance characteristics, or clinical use.