cobas^® Influenza A/B & RSV UC Test

For Research Use Only (RUO)

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

Kit configuration and components

Proposed Use for Research Use Only

RUO

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.

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

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		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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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