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

High-throughput, reliable and accurate differential diagnosis of COVID-19 and influenza

 

Symptoms of COVID-19 and influenza may look similar1. 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.

Both SARS-CoV-2 and influenza infections can present with similar symptoms, but treatment directions are likely to be different1Knowing 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 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. 

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Diagnose symptomatic patients

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

asymptomatic
Test suspected, at-risk individuals

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

hospitals
Support high-volume testing

Leverage high-volume cobas® 6800/8800 Systems and broad menu to expand COVID-19 testing solutions. 

Intended Use

Intended Use

cobas® SARS-CoV-2 & Influenza A/B assay for use on the cobas® 6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. 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 influenza B in humans and is not intended to detect influenza C. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests.

RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Testing facilities 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 infection from SARS-CoV-2, influenza A, and/or influenza B 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 epidemiological information.

cobas® SARS-CoV-2 & Influenza A/B is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 6800/8800 Systems. In the US, cobas® SARS-CoV-2 & Influenza A/B is only for use under the Food and Drug Administration’s Emergency Use Authorization.

cobas® SARS-CoV-2 & Influenza A/B assay for use on the cobas® 6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. 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 influenza B in humans and is not intended to detect influenza C.

RNA from SARS-CoV-2, influenza A, and influenza B is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, and/or influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B 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 epidemiological information.

cobas® SARS-CoV-2 & Influenza A/B is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 6800/8800 Systems.

Registration Status

FDA-Emergency Use Authorization, CE-IVD

 

In the United States:

- This test has not been FDA cleared or approved;

- 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.

Test Performance

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Test Performance

TARGET POSITIVE AGREEMENT NEGATIVE AGREEMENT LoD (95% Probit)c
SARS-CoV-2* 96.4%a 98.0%a

0.0063 TCID50/mL (SARS-CoV-2)b

0.0082 TCID50/mL (pan-Sarbecovirus)b

Influenza A** 100% 99.6% 0.086 TCID50/mL
Influenza B** 100% 99.7% 0.026 TCID50/mL

* compared to FDA-cleared EUA, cobas® SARS-CoV-2 Test on cobas® 6800/8800 Systems

** compared to FDA-cleared multiplexed real-time reverse transcriptase PCR (RT-PCR) test

a discordant results for SARS-CoV-2 are from samples of recovery/convalescent patients with decreasing viral loads close to or below the LOD of both tests

b one TCID50/mL is equal to 7,393 genome equivalents by ddPCR (per vendor’s Certificate of Analysis, USA-WA1/2020, infectious culture, Cat No NR-52281, Lot 70033175)

c  based on co-formulated, combined lot performance

 

Key Parameters

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Key Parameters

PARAMETER PERFORMANCE
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 µL
Sample processing volume 0.4 µL
Test duration Results are available within less than 3.5 hours after loading the sample on the system
System software Runs with SW versions 1.2, 1.3, and 1.4
Size and open kit stability 384 tests; 90 days with 40 re-uses