Molecular Reagent Xpert® Xpress SARS-CoV-2, Influenza A / B, Respiratory Syncytial Virus (RSV) Plus For GeneXpert Xpress System for Point-of-Care / For GeneXpert Dx or GeneXpert Infinity System for Lab 10 Tests

Features

• Xpert® Xpress CoV-2/Flu/RSV plus Test is For Use Under an Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• Testing of nasopharyngeal or anterior nasal swab specimens run on the GeneXpert Xpress System (Table and Hub Configurations) is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Product ships with minimum 60 days dating
• Testing of nasopharyngeal swab, anterior nasal swab or nasal wash/aspirate specimens run on the GeneXpert Dx and GeneXpert Infinity Systems is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests
• Positive results are indicative of active infection, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test
• Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
• Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus and/or RSV infection and should not be used as the sole basis for treatment or other patient management decisions
• Negative results must be combined with clinical observations, patient history, and/or epidemiological information
• Testing with the Xpert Xpress CoV-2/Flu/RSV plus test is intended for use by trained operators who are proficient in performing tests using either GeneXpert Dx, GeneXpert Infinity and/or GeneXpert Xpress systems
• 3-gene design supports clinicians with broader coverage for SARS-CoV-2 variants
• Single cartridge with an easy-to-use workflow, enabling effective management of limited resources
• Approximately 36 minutes time to results when running SARS-CoV-2 only; positive results in as soon as 25 minute

More Information

• Xpert Xpress CoV-2 Flu / RSV Plus FDA EUA Letter
• Xpert Xpress CoV-2 Flu / RSV Plus Point of Care IFU
• Xpert Xpress CoV-2 Flu / RSV Plus Healthcare Provider Fact Sheet
• Xpert Xpress CoV-2 Flu / RSV Plus Patients Fact Sheet
• Xpert Xpress CoV-2 Flu / RSV Plus Labs IFU
• Xpert Xpress CoV-2 Flu / RSV Plus Respiratory Comparison Sheet
• Xpert Xpress Cov-2 Flu / RSV Plus Sales Sheet