cobas® SARS-CoV-2 & Influenza A/B v2

Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> SARS-CoV-2 &amp; Influenza A/B v2
High-throughput, reliable and accurate differential diagnosis of COVID-19 and influenza

Symptoms of COVID-19 and influenza may look similar.1 Providing access to reliable and efficient testing on the fully-automated cobas® 5800/6800/8800 Systems can help guide treatment decisions and prevent further disease transmission.

Both SARS-CoV-2 and influenza infections can present with similar symptoms, but treatment directions are likely to be different.1 Knowing what infection a patient has will allow the clinician to optimally guide triage and treatment decisions, and bring confidence to patients.

The cobas® SARS-CoV-2 & Influenza A/B v2 test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus (dual target), and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider.

The cobas® SARS-CoV-2 & Influenza A/B v2 test can:

icon-symptomatic patient

Diagnose symptomatic patients

Provide accurate diagnosis of SARS-CoV-2 or influenza A/B infection for proper patient management.

icon suspect at risk

Test suspected, at-risk individuals

Offer reliable and affordable testing to reduce further virus spreading after close contact with infected individuals.

icon scalable testing

Support scalable testing

Leverage fully automated cobas® 5800/6800/8800 Systems and broad menu to expand COVID-19 testing solutions.

Test performance2

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Test performance2

Target Positive agreement Negative agreement LoD (95% Probit)b
SARS-CoV-2* 96.4%a 98%a 32 IU/mL (SARS-CoV-2)c
0.0063 TCID50 /mL (SARS-CoV-2)d
56 IU/mL (pan-Sarbecovirus)c
0.0082 TCID50 /mL (pan-Sarbecovirus)d
Influenza A* 100% 100% 0.022 TCID50/mL (A/Brisbane/02/2018 (H1N1))
0.086 TCID50/mL (A/Kansas/14/2017 (H3N2))
Influenza B* 100% 99.7% 0.017 TCID50/mL (B/Phuket/3073/2013 (Yamagata lineage))
0.026 TCID50/mL (B/Colorado/06/2017 (Victoria lineage))
*compared to highly sensitive CE-IVD assays, one comparator for SARS-CoV-2 and another for Influenza A/B
a discordant results for SARS-CoV-2 are from samples of recovery/convalescent patients with increasing viral loads close to or below the LOD of both tests
b based on co-formulated, combined lot performance
c based on first WHO International Standard for SARS-CoV-2
d based on TCID50 /mL is equal to 7,393 genome equivalents by ddPCR (per vendor’s Certificate of Analysis, USA-WA 1/2020, infectious culture, Cat No NR-52281, Lot 70033175)

Key parameters2

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Key parameters2

Parameters Description
Targets SARS-CoV-2, pan-Sarbecovirus, Influenza A, Influenza B
Sample type Nasopharyngeal swab samples collected in the Copan UTM-RT System or the BD UVT System
Nasal swab samples collected in the Copan UTM-RT System, the BD UVT System, the cobas® PCR media, and 0.9% physiological saline
Minimum amount of sample required 0.6 mL
Sample processing volume 0.4 mL
System software Runs with SW version 1.4 on cobas® 6800/8800 Systems and SW version 1.0 on cobas® 5800 System
Size and open kit stability 192 tests; 90 days with 40 re-uses


  1. Accessed October 2023.
  2. cobas® SARS-CoV-2 & Influenza A/B v2 Qualitative assay for use on the cobas® 5800/6800/8800 Systems, Instructions for Use. (10017236001-01EN Doc Rev. 1.0), Pleasanton, CA, Roche Molecular Systems, Inc. 2023


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