For Research Use Only (RUO)
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.
Centers of Disease Control and Prevention. Understanding Influenza Viruses. https://www.cdc.gov/flu/about/viruses/index.htm. Accessed 15 June 2021.
Smith DK, Seales S, Budzik C. Respiratory Syncytial Virus Bronchiolitis in Children. Am Fam Physician. 2017;95(2):94-99.
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
View Full TableTest 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%) |
Key Parameters
View Full TableKey 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 |