Xpert Xpress CoV-2/Flu/RSV plus

The Xpert Xpress CoV-2/Flu/RSV plus is an automated real-time RT-PCR test that simultaneously detects and differentiates SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) RNA in nasopharyngeal and anterior nasal swab specimens from patients with respiratory symptoms. It is performed on the GeneXpert Xpress System and aids in diagnosis of COVID-19, influenza, and RSV infections when used alongside clinical and epidemiological information.

The device has identical technological characteristics to its predicate device, using real-time reverse transcription polymerase chain reaction (RT-qPCR) for automated nucleic acid extraction, amplification, detection, and result interpretation. It produces qualitative results in under 36 minutes and includes internal Sample Processing Control and Probe Check Control mechanisms within single-use disposable cartridges.

Not stated in this summary.

The device is substantially equivalent because it targets the same analytes (SARS-CoV-2, Flu A, Flu B, RSV), uses the same specimen types and transport media, employs identical RT-qPCR technology, and produces the same qualitative results format as the predicate device (K242071). The two design modifications—turning off Signal Loss Detection in the Flu B channel and revising the result reporting algorithm for SARS-CoV-2 only mode—did not impact performance; re-analysis of 16,264 test results showed identical numbers of valid runs and non-determinate results between the original and updated assay definition files, demonstrating these changes do not raise different questions of safety or effectiveness.