Both SARS-CoV-2 and influenza infections can present with similar symptoms, but treatment directions are likely to be different1. Knowing what infection a patient has will allow the clinician to optimally guide triage and treatment decisions, and bring confidence to patients. Providing access to reliable and efficient testing on the fully-automated cobas® 6800/8800 Systems can help guide treatment decisions and prevent further disease transmission.
The cobas® SARS-CoV-2 & Influenza A/B 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, 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.
Provide accurate diagnosis of SARS-CoV-2 or Influenza A/B infection for proper patient management.
Offer reliable and affordable testing to reduce further virus spreading after close contact with infected individuals.
Leverage high-volume cobas® 6800/8800 Systems and broad menu to expand COVID-19 testing solutions.
FDA-Emergency Use Authorization
This test has not been FDA cleared or approved, but is currently under review for 510k clearance;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
|TARGET||POSITIVE AGREEMENT||NEGATIVE AGREEMENT||LoD (95% Probit)b|
|SARS-CoV-2**||98.6%a||99.7%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**||98.8%||99.7%||0.086 TCID50/mL|
|Influenza B**||100%||100%||0.026 TCID50/mL|
* cobas® SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas® 5800/6800/8800 Systems (package Insert), Pleasanton, CA, Roche Molecular Systems, Inc. 2020
** 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 first WHO International Standard for SARS-CoV-2
d one 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)
|Targets||SARS-CoV-2, pan-Sarbecovirus, Influenza A, Influenza B|
||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||384 tests; 90 days with 40 re-uses|