Respiratory Test Kit Xpert® Xpress CoV-2 plus COVID-19 10 Tests CLIA Waived

Features

• The Xpert Xpress CoV-2 plus test is only for use under the Food and Drug Administration's Emergency Use Authorization: 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
• Product ships with minimum 60 days dating
• The Xpert Xpress CoV-2 plustest is a rapid, real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, oropharyngeal swab or nasal wash/aspirate specimens from individuals suspected of COVID-19 by their healthcare provider, as well as anterior nasal swab specimens from any individual, including from individuals without symptoms or other reasons to suspect COVID-19
• Testing of nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, oropharyngeal swab or nasal wash/aspirate specimens using the Xpert Xpress CoV-2 plus test run on the GeneXpert Dx and GeneXpert Infinity systems is limited to labs 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
• Testing of nasopharyngeal swab, anterior nasal swab or mid-turbinate nasal swab specimens using the Xpert Xpress CoV-2 plus test run on the GeneXpert Xpress System (Tablet and Hub Configurations) is limited to labs certified under CLIA that meet requirements to perform high, moderate, or waived complexity tests; testing of these specimens is authorized for use at the Point of Care, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• Positive results are indicative of active infection with SARS-CoV-2; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Positive results do not rule out bacterial infection or co-infection with other viruses
• Negative results do not preclude SARS-CoV-2 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 epidemiological information
• Testing with the Xpert Xpress CoV-2 plustest is intended for use by trained operators who are proficient in performing tests using either GeneXpert Dx, GeneXpert Infinity and/or GeneXpert Xpress systems
• Materials required but not provided using GeneXpert Xpress System (Tablet configuration): GeneXpert Xpress II and IV instruments with proprietary GeneXpert Xpress Software Version 5.0 and 5.1, tablet computer device with touchscreen, barcode scanner, external CD drive, wireless printer, Getting Started Guide, and GeneXpert Xpress System User’s Guide
• Materials required but not provided using GeneXpert Xpress System (Hub configuration): GeneXpert Xpress IV instrument, GeneXpert Hub with proprietary GeneXpert Xpress Software Version 6.1 or higher, GeneXpert Hub with integrated computer, touchscreen monitor and barcode scanner, external CD drive, Getting Started Guide, and GeneXpert Xpress System User’s Guide

More Information

• Xpert Xpress CoV-2 plus FDA EUA Letter
• Xpert Xpress CoV-2 plus Package Insert
• Xpert Xpress CoV-2 plus Healthcare Provider Fact Sheet
• Xpert Xpress CoV-2 plus Patients Fact Sheet
• Xpert Xpress CoV-2 plus IFU for Labs
• Xpert Xpress CoV-2 plus IFU for Point of Care