Rapid answers to manage the unknown

Click here to get more information about the cobas® SARS-CoV-2 & Influenza A/B assay

 

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 900,000 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 on the front line now have the urgent answers they need to rule-in or rule-out these three infections.

cobas® SARS-CoV-2 & Influenza A/B performance2

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Intended use statements for cobas® SARS-CoV-2 & Influenza A/B for use on the cobas® Liat® System

CE-IVD

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.

FDA-Emergency use only
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 provider-collected nasopharyngeal and nasal swabs, and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) 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 simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleic acids in clinical specimens and is not intended to detect influenza C virus. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in respiratory specimens during the acute phase of 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 SARS-CoV-2, influenza A, and/or influenza B infection 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.

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.

In the United States (US), testing with cobas® SARS-CoV-2 & Influenza A/B is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests. cobas® SARS-CoV-2 & Influenza A/B is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Testing facilities within the U.S. and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities. In the U.S., cobas® SARS-CoV-2 & Influenza A/B is only for use under the Food and Drug Administration’s Emergency Use Authorization.

In the United States:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus and influenza B virus; not for any other viruses or pathogens; and
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner

Learn more about the expanding menus of assays.


*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 influenza B, respectively.

References:
1. https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-disease-2019-vs-the-flu. Accessed 09 Sep 2020.

2.
cobas® SARS-CoV-2 & Influenza A/B [package insert V01]. Pleasanton, CA: Roche Molecular Systems, Inc., 2020.

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