cobas® Influenza A/B & RSV UC Test

For Research Use Only (RUO)
cobas Influenza A/B & RSV UC
cobas® Influenza A/B & RSV UC Test

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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.

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

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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
*Dead volume of 0.2 mL is identified for the cobas omni Secondary tubes. Other tubes compatible with cobas® 6800/8800 Systems (consult User Assistance Guide) may have different dead volume and require more or less minimum volume.
Research Use Only

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.

 

References

  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.

Overview

Detailed Specifications

Ordering Information

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