cobas® Influenza A/B and RSV Assay

Detects and differentiates influenza A, influenza B and RSV

The young and old are particularly vulnerable to respiratory infections. Influenza has been known to kill up to 650,000 people every year,¹ while RSV is the leading cause of lower respiratory disease in children younger than 4 years of age; globally, nearly all children have been infected with RSV at least once, by age two.² On the other end of the age continuum, RSV is also common in adults older than 65 and their risk of serious infection increases with age.³ Timely test results can help guide clinical decisions regarding treatment and patient isolation for infection control.

cobas^® Influenza A/B & RSV delivers:

Three viruses, 20 minutes to diagnosis, for your patients at higher risk
Simple to use with minimal hands-on-time, and easy interpretation of results
When it is not COVID-19, and other respiratory viruses are suspected

The growing menu of molecular POC assays together with this innovative, connected analyzer, forms the Roche total point-of-care PCR solution. Now, emergency rooms, primary care and other novel POC settings can reliably standardize and mobilize molecular testing, enhancing patient safety and satisfaction.

cobas^® Influenza A/B & RSV performance⁴

Influenza A^*

LOD: 2 x 10^-3 – 2 x 10^-2 TCID ₅₀/mL

Positive Agreement

(95% CI: 96.0% - 99.4%)

Negative Agreement

(95% CI: 95.4% - 97.3%)

Influenza B^*

LOD: 2 x 10^-3 – 4 x 10^-3 TCID ₅₀/mL

Positive Agreement

(95% CI: 93.9% - 99.3%)

Negative Agreement

(95% CI: 98.9%-99.7%)

RSV^*

LOD: 4 x 10^-1 TCID ₅₀/mL

Positive Agreement

(95% CI: 94.5%-99.1%)

Negative Agreement

(95% CI: 97.6%-98.9%)

*Performance of the test was compared with an FDA-cleared, laboratory-based, multiplexed, real-time, reverse transcription PCR (RT-PCR) test across three targets.

CI=confidence intervals. LOD=limit of detection. TCID=tissue culture infective dose.

The cobas^® Liat^® PCR System vs. conventional methods

Influenza A/B rapid
antigen test

(Test 1 of 2)

Patient suspected of influenza

Specimen collected to perform a rapid
influenza diagnostic test (RITD)

Negative result needs confirmation.
Risk of delayed treatment decisions.

Samples sent to the lab for PCR testing (4-24 hours)

Patient less likely to benefit from antiviral treatment
started >48 hours after symptom onset⁵

RSV rapid
antigen test

(Test 2 of 2)

Patient suspected of RSV

Specimen collected to perform an RSV
rapid antigen diagnostic test (RADT)

Negative result still leave unanswered questions.
Risk of delayed treatment decisions.

cobas^® Influenza A/B
& RSV

(3 targets in 1 test)

Patient suspected of influenza or RSV

Specimen collected

Perform cobas^® Influenza A/B & RSV test
(Definitive results in 20 minutes)

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Learn more about the expanding menu of assays

cobas^® SARS-CoV-2 & Influenza A/B

Detect and differentiate SARS-CoV-2, influenza A and influenza B in 20 minutes from a single sample and in just one RT-PCR test for use on the cobas® Liat® System

cobas^® Strep A

With lab-quality results in ~15 minutes, cobas® Strep A, for use on the cobas® Liat® System aids clinicians to make immediate, informed treatment decisions.

cobas^® Cdiff

Provide accurate, on-demand results in 20 minutes for the detection of toxigenic C. diff with the POC PCR test for use on the cobas® Liat® System

cobas^® SARS-CoV-2

Inform decisions at the POC with targeted RT-PCR SARS-CoV-2 test results in 20 minutes for both asymptomatic and symptomatic individuals using the cobas® Liat® System

...

cobas^® Liat^® System

Rapidly test, triage, and treat your patients with the accuracy, simplicity, and security needed at the point of care.

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Total commitment deserves the total point-of-care PCR solution

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Intended use

The cobas^® Influenza A/B and RSV Nucleic acid test for use on the cobas^® Liat^® System (cobas^® Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid 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 differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C.

Registration status

CE-IVD, FDA 510(k) cleared, CLIA waived

The cobas^® Liat^® System is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

Test for it. Don’t ignore it.

Learn more

Respiratory tract infections

The non-specific clinical presentation of respiratory infections poses a considerable challenge to the differential diagnosis of pathogens. What impact can a timely and accurate diagnosis have on patient management?

Healthcare-associated infections (HAIs)

From prolonging institutional stays to creating long-term disability, healthcare-associated infections place a tremendous financial burden on health systems.

Antibiotic resistance and diagnostic testing

As mankind continues its widespread use of antibiotics, antimicrobial resistance will continue to pose a threat to the global healthcare system.

References

https://www.who.int/news-room/spotlight/influenza-are-we-ready Accessed 14 sept 2021.
Collins PL and Grahm BS. Viral and host factors in human respiratory syncytial virus pathogenesis. J Virol . 2008:82(5);2040-2055.
Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE. Respiratory Syncytial Virus Infection in Elderly and High-Risk Adults. NEJM . 2005:352(17);1749-59.
cobas® Influenza A/B & RSV [package insert]. Pleasanton, CA: Roche Molecular Systems, Inc., 2016.
Centers for Disease Control and Prevention. Use of antivirals. http://www.cdc.gov/flu/professionals/antivirals/antiviral-use-influenza.htm. Accessed April 20, 2017.

cobas® Influenza A/B & RSV Assay

Related information

cobas® Influenza A/B & RSV performance4

Influenza A*

LOD: 2 x 10-3 – 2 x 10-2 TCID ­50/mL

Positive Agreement

(95% CI: 96.0% - 99.4%)

Negative Agreement

(95% CI: 95.4% - 97.3%)

Influenza B*

LOD: 2 x 10-3 – 4 x 10-3 TCID ­50/mL

Positive Agreement

(95% CI: 93.9% - 99.3%)

Negative Agreement

(95% CI: 98.9%-99.7%)

RSV*

LOD: 4 x 10-1 TCID ­50/mL

Positive Agreement

(95% CI: 94.5%-99.1%)

Negative Agreement

(95% CI: 97.6%-98.9%)

The cobas® Liat® PCR System vs. conventional methods

Influenza A/B rapid antigen test

(Test 1 of 2)

RSV rapid antigen test

(Test 2 of 2)

cobas® Influenza A/B & RSV

(3 targets in 1 test)

Learn more about the expanding menu of assays

cobas® Liat® System

Total commitment deserves the total point-of-care PCR solution

Test for it. Don’t ignore it.

Related assays

cobas^® Influenza A/B & RSV Assay

cobas^® Influenza A/B & RSV performance⁴

Influenza A^*

LOD: 2 x 10^-3 – 2 x 10^-2 TCID ₅₀/mL

Influenza B^*

LOD: 2 x 10^-3 – 4 x 10^-3 TCID ₅₀/mL

RSV^*

LOD: 4 x 10^-1 TCID ₅₀/mL

The cobas^® Liat^® PCR System vs. conventional methods

Influenza A/B rapid
antigen test

RSV rapid
antigen test

cobas^® Influenza A/B
& RSV

cobas^® Liat^® System