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

Features

• Xpert® Xpress CoV-2/Flu/RSV plus test, performed on the GeneXpert® Dx and GeneXpert Infinity Systems, 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
• For in vitro diagnostic use (US-IVD Moderately Complex), contact your Account Manager for help with product access
• The Xpert Xpress CoV-2/Flu/RSV plus is intended for use in the differential detection of SARS-CoV-2, influenza A, influenza B and/or RSV RNA and aids in the diagnosis of COVID-19, influenza and/or RSV infections if used in conjunction with other clinical and epidemiological information, and laboratory findings
• 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; the results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions
• The GeneXpert Instrument Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in simple or complex samples using real-time PCR and RT-PCR assays
• The Xpert Xpress CoV-2/Flu/RSV plus test includes reagents for the detection of SARS-CoV-2, Flu A, Flu B and RSV viral RNA in either nasopharyngeal swab or anterior nasal swab specimens
• GeneXpert Dx System or GeneXpert Infinity System required but not provided
• Positive results for SARS-CoV-2 or suspected novel influenza should be reported to state, local, or federal health departments according to local reporting requirements

More Information

• Xpert Xpress CoV-2, FLU, RSV Plus 510K IFU