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

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