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cobas® liat SARS-CoV-2, Influenza A/B & RSV Assay*

Rapid answers to manage the unknown

Country Specific Labeling See country-specific product labeling for regulatory status.
Reduce the risk of a misdiagnosis with an accurate test you can trust

SARS-CoV-2, influenza, and RSV have overlapping symptoms.1,2,3 It is difficult for clinicians to identify based on signs and symptoms alone and if left undiagnosed, may result in health complications or community spread.4

The cobas® liat SARS-CoV-2, Influenza A/B & RSV assay 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, influenza B, and RSV in 20 minutes from a single nasal sample and in just one test.

Relying on the rapid and accurate cobas® liat SARS-CoV-2, Influenza A/B & RSV assay performance, healthcare providers on the front line now have the urgent answers they need to confidently triage patients with respiratory symptoms.

cobas® SARS-CoV-2, Influenza A/B and RSV performance5

Target Positive Agreement Negative Agreement LoD†
SARS-CoV-2 96.7% 96.7% 3.5 x 10-3 TCID50/mL
Influenza A 100% 98.1% 3.25 x 10-3 - 2.95 x 10-1 TCID50/mL
Influenza B 100% 97.7% 1.83 x 10-1 - 9.79 x 10-1 TCID50/mL
RSV 100% 97.2% 2.4 x 10-2 - 2.69 x 10-1 TCID50/mL
†Multiple isolates were used to determine the LoD for influenza A/B and RSV, but only one isolate was used to determine the LoD for SARS-CoV-2.

Intended use

The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is 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. 

Results are for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV viral RNA in clinical specimens and are not intended to detect influenza C virus. SARS-CoV-2, influenza A, influenza B and RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens  during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not be the definitive cause of disease.

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

The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for use by trained operators specifically instructed in the use of the cobas® liat system and the cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

References

  1. Jain H, Schweitzer JW, Justice NA. Respiratory Syncytial Virus Infection in Children. [Updated 2023 Jun 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Retrieved September 10, 2024, from https://www.ncbi.nlm.nih.gov/books/NBK459215/.
  2. CDC Clinical Signs and Symptoms of Influenza. Retrieved September 10, 2024, from https://www.cdc.gov/flu/professionals/acip/clinical.htm.
  3. CDC Symptoms of Coronavirus. Retrieved September 10, 2024, from https://www.cdc.gov/covid/signs-symptoms/?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fsymptoms-testing%2Fsymptoms.html.
  4. May, L., Robbins, E. M., Canchola, J. A., Chugh, K., & Tran, N. K. (2023). A study to assess the impact of the cobas point-of-care RT-PCR assay (SARS-CoV-2 and Influenza A/B) on patient clinical management in the emergency department of the University of California at Davis Medical Center. Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology168, 105597. Retrieved September 10, 2024, from https://doi.org/10.1016/j.jcv.2023.105597.
  5. cobas® SARS-CoV-2, Influenza A/B and RSV Package Insert, Pleasanton, CA, Roche Molecular Systems Inc.

 

*Disclaimer

This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform high, moderate or waived complexity tests. This product is 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.

This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, influenza B, and RSV, not for any other viruses or pathogens.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Learn more about the cobas® liat SARS-CoV-2, Influenza A/B & RSV Assay

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