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cobas® SARS-CoV-2 &
Influenza A/B Assay

Rapid answers to manage the unknown

SARS_Influenza_AB
Reduce the risk of a misdiagnosis with an accurate test you can trust

Symptoms of COVID-19 and influenza may look the same. It can be difficult for clinicians to identify based on signs & symptoms alone and if left undiagnosed, may result in health complications or community spread.

With more than 1,000,000 deaths1 from COVID-19 reported so far—and half a million deaths on average from influenza every year—effective tools are needed to deliver rapid results to manage patient care early and effectively in emergency care settings.

 

The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates SARS-CoV-2, influenza A and influenza B in 20 minutes from a single nasal sample and in just one test.

 

Relying on the rapid and accurate performance of cobas® SARS-CoV-2 & Influenza A/B, healthcare providers in emergency care settings now have the urgent answers they need to rule-in or rule-out these three infections.

loading assay tube into cobas Liat system

 

cobas® SARS-CoV-2 & Influenza A/B performance 2

 

SARS-CoV-2*

 

LOD: 1.2 x 10-2 TCID 50/mL

Positive Agreement 

FLU AB graph B

(95% CI: 93.6%-100%)

Negative Agreement 

FLU AB graph B

(95% CI: 98.4%-100%)

Influenza A†


LOD: 2 x 10-3 – 2 x 10-2 TCID 50/mL

Positive Agreement 

FLU AB graph A

(95% CI: 96.0%-99.4%)

Negative Agreement 

FLU AB graph A

(95% CI: 95.4%-97.3%)

Influenza B†


LOD: 2 x 10-3 – 4 x 10-3 TCID 50/mL






Positive Agreement 

FLU AB graph A

(95% CI: 93.9%-99.3%)

Negative Agreement 

FLU AB graph A

(95% CI: 98.9%-99.7%)

* Compared to the cobas® SARS-CoV-2 Test on cobas® 6800/8800 Systems; EUA data.

† Compared to an FDA-cleared laboratory based multiplexed real-time reverse transcriptase PCR (RT-PCR) test;
combined PPA and NPA from retrospective and prospective samples for influenza A and B, respectively. 

CI=confidence intervals. LOD=limit of detection. CFU=colony-forming unit. TCID=tissue culture infective dose.

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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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Intended Use

Intended Use

The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA in healthcare worker-collected nasopharyngeal and nasal swabs and self-collected nasal swabs (collected on site with instruction by a healthcare professional) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

 

cobas® SARS-CoV-2 & Influenza A/B is intended for use in the detection and differentiation of SARS-CoV-2, influenza A, and influenza B in clinical specimens and is not intended to detect influenza C. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in upper respiratory specimens during infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. 

Negative results do not preclude infection from SARS-CoV-2, influenza A, and/or influenza B and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

 

Negative results obtained from individuals who are not exhibiting clinical signs and symptoms associated with respiratory viral infection at the time of specimen collection should be interpreted with particular caution. Negative results in asymptomatic individuals cannot be used as definitive evidence that an individual has not been exposed to SARS-CoV-2 or influenza viruses and has not been infected with any of these viruses. 

 

cobas® SARS-CoV-2 & Influenza A/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat® System at the point of care (POC) or in a clinical laboratory setting.

References

  1. John hopkins Medicine. Coronavirus Disease 2019 vs. the Flu. https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-disease-2019-vs-the-flu. Accessed 8Oct2020.
  2. cobas® SARS-CoV-2 & Influenza A/B [package insert V01]. Pleasanton, CA: Roche Molecular Systems, Inc., 2020.

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