| Product Dating |
McKesson Acceptable Dating: we will ship >= 60 days | McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 30 days | McKesson Acceptable Dating: we will ship >= 60 days |
| Test Name |
SARS-CoV-2, Influenza A / B, Respiratory Syncytial Virus (RSV) Plus | Strep A | Chlamydia Trachomatis / Neisseria Gonorrhoeae (CT / NG) | Neisseria Gonorrhoea (NG) | SARS-CoV-2, Influenza A / B |
| Features and Benefits |
- 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
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- Xpert® Xpress Strep A is a qualitative real-time PCR test providing accurate detection of Group A Streptococcus in as soon as 18 minutes
- Xpert® Xpress Strep A provides medically actionable and timely information to clinicians to support improved patient management and antibiotic stewardship
- For In Vitro Diagnostic Use
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- 90 minute detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)
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- Qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens
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- cobas® SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas® liat analyzer has successfully completed its transition from Emergency Use Authorization (EUA) product to 510(k) cleared product
- Product ships from McKesson with minimum 30 days dating
- The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B virus nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection
- cobas® SARS-CoV-2 & Influenza A/B is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings
- The new cobas SARS-CoV-2 & Influenza A/B test analyzes nucleic acids from nasopharyngeal and nasal swab samples and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) to enable frontline healthcare workers to quickly identify and differentiate these similarly presenting infections
- cobas® SARS-CoV-2 & Influenza A/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat System
- The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA
- Kit includes: 20 tests, 2 cobas® transfer pipette packs (12 pipettes/pack - P/N 9329676001), 1 package insert barcode card, cobas Liat Internal Process Control, Proteinase K, cobas Liat Magnetic Glass Particles, Lysis buffer, wash buffer, Elution buffer, A/B Master Mix 1, A/B Master Mix 2, A/B Master Mix 3
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