cobas® SARS-CoV-2 & Influenza A/B

Nucleic acid test for use on the cobas® liat system

IVD For in vitro diagnostic use.
Reduce the risk of a misdiagnosis with an accurate nucleic acid test you can trust

Symptoms of COVID-19 and influenza may look the same. It can be difficult for clinicians to identify based on signs & symptoms alone and if left undiagnosed, may result in health complications or community spread.

The cobas® SARS-CoV-2 & Influenza A/B test for use on the cobas® Liat® System provides urgent, accurate answers to rule-in or rule-out influenza and COVID-19 in 20 minutes from a single test, enabling early and effective patient care.

cobas® SARS-CoV-2 & Influenza A/B:

  • One sample, one test, 20 minutes, know if it’s COVID-19 or Flu
  • Take the workload out of testing with simple intuitive user handling
  • Minimize cross-contamination and risk of exposure during testing with the closed-system design

Your priority is your patients.  Enable the answers you need to support efficient, on-demand patient care. The cobas® liat system enables definitive and rapid diagnosis, combining powerful PCR technology with fast turnaround time, 20 minutes or less, allowing sample to answer while patients wait.

cobas® SARS-CoV-2 & Influenza A/B performance1

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cobas® SARS-CoV-2 & Influenza A/B performance1

Target Positive Agreement Negative Agreement LoD
SARS-CoV-2* 95.3% 99.4% 1.2 x 10-2 TCID ­­50/mL
Influenza A** 96.8% 99.6% 2 x 10-3 – 2 x 10-2 TCID ­­50/mL
Influenza B** 100% 100% 2 x 10-3 – 4 x 10-3 TCID ­­50/mL
1cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System, Package Insert V01, Pleasanton, CA; Roche Molecular Systems, Inc., 2020. *Compared to a composite comparator of three highly sensitive FDA-authorized laboratory-based RT-PCR EUA essays; 510(k)/CLIA-waiver data using NPS specimens **Compared to an FDA-acceptable molecular comparator for influenza; combined PPA and NPA from retrospective and prospective samples for influenza A and influenza B, respectively, 510(k)/CLIA-waiver data using NPS specimens CI=confidence intervals. LOD=limit of detection. CFU=colony-forming unit. TCID=tissue culture infective dose.
cobas® Liat® System

cobas® liat system

Rapidly test, triage, and treat your patients with the accuracy, simplicity, and security needed at the point of care.

Intended Use

Intended Use

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. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.

 

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. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection.  Positive results do not rule out co-infection with other organisms. The agent(s) detected by the cobas SARS-CoV-2 & Influenza A/B may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Registration status

CE-IVD, FDA 510(k) cleared, CLIA waived

The cobas® liat system is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

References

  1. cobas® SARS-CoV-2 & Influenza A/B [package insert V05]. Pleasanton, CA: Roche Molecular Systems, Inc., 2023.

COBAS and LIAT are trademarks of Roche.

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Detailed Specifications

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