cobas® Influenza A/B & RSV UC Test

Influenza A/B

High-throughput respiratory solution on the cobas® 6800/8800 Systems for detecting and differentiating Influenza A, Influenza B and RSV

 

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.

Prompt and accurate detection of influenza and RSV infections can help target the use of antivirals, reduce inappropriate antibiotic use and unnecessary hospitalization. 

The cobas® Influenza A/B & RSV UC Test for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is a high-throughput 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

Lab
Simplified and turnkey solution

 

Run fully compliant, CE-IVD workflow without further optimization. Positive and negative controls included.

Consolidated testing
Consolidated menu on high-throughput systems

 

Benefit from fully automated cobas® 6800/8800 Systems and an industry-leading menu to tackle seasonal high demand.

Intended Use

Intended Use

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 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. The test is intended for use as an aid in the diagnosis and differentiation of influenza A, influenza B, and RSV in humans and is not intended to detect influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, 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.

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 professional use in a clinical laboratory setting.

 
  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 BDUVT 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