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cobas® Influenza A/B & RSV UC Test

For Research Use Only (RUO)

Influenza A/B
Detecting and differentiating Influenza A, Influenza B and RSV on the high-throughput cobas® 6800/8800 Systems

Influenza virus, primarily type A and type B, is responsible for human epidemics causing worldwide morbidity and mortality.1 Respiratory syncytial virus is a leading cause of lower respiratory tract infections and hospitalizations in infants and children,2 and is associated with a substantial disease and health economic burden in older adults.3 

The cobas® Influenza A/B & RSV UC Test for use with the cobas omni Utility Channel on the high-throughput cobas® 6800/8800 Systems and is a multiplex assay for the qualitative detection and differentiation of respiratory viruses Influenza A, Influenza B and RSV.

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Benefits of the cobas® Influenza A/B & RSV UC Test

Seamless integration on cobas® 6800/8800 Systems

Seamless integration on cobas® 6800/8800 Systems

Kit configuration and components

Kit configuration and components
Proposed Use for Research Use Only

Proposed Use for Research Use Only

The cobas® Influenza A/B & RSV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems (RUO) is an automated, multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) assay for the timely in vitro qualitative detection and discrimination of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors to support the understanding of virus epidemiology for Population Health Management. The cobas® Influenza A/B & RSV UC Qualitative Nucleic Acid test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is intended for research use only and is not for use in diagnostic procedures.

 

  1. Centers of Disease Control and Prevention. Understanding Influenza Viruses. https://www.cdc.gov/flu/about/viruses/index.htm. Accessed 15 June 2021.  

  2. Smith DK, Seales S, Budzik C. Respiratory Syncytial Virus Bronchiolitis in Children. Am Fam Physician. 2017;95(2):94-99.

  3. Ackerson B, Tseng HF, Sy LS, et al. Severe Morbidity and Mortality Associated With Respiratory Syncytial Virus Versus Influenza Infection in Hospitalized Older Adults. Clin Infect Dis. 2019;69(2):197-203. doi:10.1093/cid/ciy991.

Test performance

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Test performance

    Test results Agreement Statistics
Virus Number of Samples Concordant Positive (N) Discordant Positive (N) Concordant Negative (N) Discordant Negative (N) Agreement Parameter Percent Agreement (%) 95% CI (LCL, UCL)*
Influenza A 377 91 6 280 0 PPA 100.0% (95.9%, 100.0%)
NPA 97.9% (95.5%, 99.0%)
Inluenza B 377 85 4 287 1 PPA 98.8% (93.7%, 99.8%)
NPA 98.6% (96.5%, 99.5%)
RSV  377 98 2 277 0 PPA 100.0% (96.2%, 100.0%)
NPA 99.3% (97.4%, 99.8%)

 

Performance comparison of cobas® Influenza A/B & RSV UC with cobas® Influenza A/B & RSV for use on the cobas® Liat® System PPA = Positive Percent Agreement; NPA = Negative Percent Agreement; CI = confidence interval; LCL = Lower confidence Limit; UCL = Upper confidence Limit *Confidence interval is calculated using Wilson's Score method

Key Parameters

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Key Parameters

PARAMETER PERFORMANCE
Targets Influenza A, influenza B, respiratory syncytial virus
Sample and media types Nasopharyngeal swab samples collected in the Copan UTM-RT® System, the BD™ UVT System or equivalent
Minimum amount of sample required 0.6 mL
Sample processing volume 0.4 mL
Test duration Results are available within less than 3.5 hours after loading the sample on the system
System software cobas® 6800/8800 System Software 1.4 or higher
cobas® SARS-CoV-2
cobas® SARS-CoV-2
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IVD For in vitro diagnostic use.
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cobas® SARS-CoV-2 & Influenza A/B v2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® SARS-CoV-2 & Influenza A/B v2 assay for use on the cobas® 5800/6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B v2) 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 v2 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 v2 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® 5800/6800/8800 Systems.
IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> SARS-CoV-2 Qualitative
cobas® SARS-CoV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 Systems cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal specimens collected from symptomatic individuals suspected of COVID-19 by their healthcare provider.Results are for the detection of SARS-CoV-2 RNA. Positive results are indicative of the presence of SARS-CoV-2 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 pathogens.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results are meant to be used in conjunction with clinical observations, patient history, recent exposures and epidemiological information, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. cobas® SARS-CoV-2 Qualitative 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® 5800/6800/8800 Systems. 
IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> SARS-CoV-2 Duo
cobas® SARS-CoV-2 Duo Qualitative and quantitative assay for use on the cobas® 6800/8800 Systems cobas® SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems (cobas® SARS CoV 2 Duo) is an automated real-time RT-PCR assay for the qualitative detection of SARS-CoV-2 RNA in healthcare provider instructed self-collected nasal (anterior nares and mid-turbinate) swab specimens (collected on site), and healthcare provider-collected nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. This assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of cobas® SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider. cobas® SARS-CoV-2 Duo is for use only under Emergency Use Authorization (EUA) in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests.Results are for the detection of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. At this time, correlation of viral load with a specific clinical diagnosis, prognosis or patient management decision has not been clinically established. Patient management should therefore be based on the qualitative result upon consideration of clinical observation, patient history and other diagnostic information. The numerical values for the viral load are for information only. Positive results do not rule out bacterial infection or co- infection with other viruses.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, recent exposures and epidemiological information. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. cobas® SARS-CoV-2 Duo 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. cobas® SARS-CoV-2 Duo is only for use under the Food and Drug Administration’s Emergency Use Authorization.
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