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
 
Manufacturer #
XP3COV2/FLU/RSV-10
Brand
Xpert® Xpress
Manufacturer
Cepheid
Country of Origin
Unknown
Application
Molecular Reagent
For Use With
For GeneXpert Xpress System for Point-of-Care / For GeneXpert Dx or GeneXpert Infinity System for Lab
Number of Tests
10 Tests
 
 
Sample Type
Anterior Nasal / Nasopharyngeal / Nasal Wash, Aspirate Sample
Specialty
Molecular
Test Category
Respiratory
Test Format
Cartridge
Test Name
SARS-CoV-2, Influenza A / B, Respiratory Syncytial Virus (RSV) Plus
Test Type
Real-time PCR
Time to Results
25 Minute Results (Positive Results)
UNSPSC Code
41116144
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
 
MFR# XP3COV2/FLU/RSV-10
SKU: 330-0166
SKU2: 1198255