cobas® Influenza A/B & RSV

Nucleic acid test for use on the cobas® liat system

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> Influenza A/B &amp; RSV
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

 

Choosing speed and accuracy, anywhere and anytime is the Roche Total Solution for all that you value. The total point-of-care solution that is simply quick, gives you the confidence of PCR accuracy, and puts you in control, now with conveniently remote results, automatic reporting and one-click updates.

cobas® Influenza A/B & RSV performance4

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cobas® Influenza A/B & RSV performance4

  Positive Agreement Negative Agreement
Influenza A*
LOD: 2 x 10-3 – 2 x 10-2 TCID ­50/mL
98.4 %
(95% CI: 96.0% - 99.4%)
96.5 %
(95% CI: 95.4% - 97.3%)
Influenza B*
LOD: 2 x 10-3 – 4 x 10-3 TCID ­­50/mL
97.9 %
(95% CI: 93.9% - 99.3%)
99.4 %
(95% CI: 98.9%-99.7%)
RSV*
LOD: 4 x 10-1 TCID ­­50/mL
97.8 %
(95% CI: 94.5%-99.1%)
98.4 %
(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; CLIA data. CI=confidence intervals. LOD=limit of detection. TCID=tissue culture infective dose.
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.

The cobas® liat system vs. conventional methods

Influenza A/B rapid antigen test

(Test 1 of 2)

patient icon

Patient suspected of influenza

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swab sample icon

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

warning icon

Negative result needs confirmation. Risk of delayed treatment decisions.

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dna icon

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

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patient icon

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

RSV rapid antigen test

(Test 2 of 2)

patient icon

Patient suspected of RSV

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swab sample icon

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

warning icon

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

cobas® Influenza A/B & RSV

(3 targets in 1 test)

patient icon

Patient suspected of influenza or RSV

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swab sample icon

Specimen collected
 

liat icon

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

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.

References

  1. https://www.who.int/news-room/spotlight/influenza-are-we-ready Accessed 10 November 2023.
  2. Collins PL and Grahm BS. Viral and host factors in human respiratory syncytial virus pathogenesis. J Virol . 2008:82(5);2040-2055.
  3. 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.
  4. cobas®  Influenza A/B & RSV [instructions for use]. Pleasanton, CA: Roche Molecular Systems, Inc., 2021, USA, v2; EU v6.
  5. Centers for Disease Control and Prevention. Use of antivirals. https://www.cdc.gov/flu/treatment/whatyoushould.htm. Accessed 10 November 2023.

 

COBAS and LIAT are trademarks of Roche.

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