Molecular Reagent Xpert® Xpress SARS-CoV-2, Influenza A / B, RSV Plus CLIA Waived For GeneXpert Xpress System 10 Tests

Features

• Xpert® Xpress CoV-2/Flu/RSV plus is now CLIA Complexity: Waived
• The Xpert® Xpress CoV-2/Flu/RSV plus test, performed on the GeneXpert® Xpress System, is an automated multiplexed real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for use in the simultaneous in vitro qualitative detection and differentiation of severe acute respiratory syndrome coronavirus (SARS-CoV-2), influenza A, influenza B, and/or respiratory syncytial virus (RSV) viral RNA in nasopharyngeal swab and anterior nasal swab specimens collected from individuals with signs and symptoms of respiratory tract infection
• Detects SARS-CoV-2, influenza A, influenza B, and/or RSV simultaneously
• Xpert Xpress CoV-2/Flu/RSV plus allows for accurate and fast results, optimizing diagnostic efficiency and improving the provision of appropriate treatment
• Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test
• Negative results do not preclude SARS-CoV-2, influenza A, influenza B, and/or RSV infection
• Xpert Xpress CoV-2/Flu/RSV plus test is performed on GeneXpert Xpress System
• Materials Required but not provided: Nylon flocked swabs, viral transport medium (VTM), Universal Transport Medium (UTM) and eNAT® Molecular Transport Medium are compatible for use with the Xpert Xpress CoV-2/Flu/RSV plus test

More Information

• Xpert Xpress COV-2 Flu RSV plus Clia Waived
• Cepheid 510K Status / Software Updates June 2025