Summary: The FDA has granted Emergency Use Authorization for Roche’s cobas liat SARS-CoV-2, Influenza A/B & RSV test, a rapid multiplex RT-PCR assay that delivers results in 20 minutes for detecting multiple respiratory viruses from a single sample.


  1. The cobas liat test can detect SARS-CoV-2, influenza A/B, and RSV from one sample in just 20 minutes, aiding quick diagnosis in various healthcare settings.
  2. This multiplex test supports swift clinical decision-making, reducing unnecessary antibiotic use and facilitating targeted treatments, ultimately improving patient outcomes and system efficiency.
  3. Roche’s new test complements its extensive range of diagnostic assays, with plans for further regulatory approvals and market expansions in the future.

Roche announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated, multiplex, real-time polymerase chain reaction (RT-PCR) assay on the cobas liat system.

Test for COVID, Influenza, and RSV

Producing results in just 20 minutes on a compact analyzer suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). 

“Diagnostics play a critical role in the fight against respiratory illness,” says Matt Sause, CEO of Roche Diagnostics. “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.”

Rapid multiplex PCR Test 

Introducing rapid multiplex PCR diagnostic tests into near-patient care environments such as emergency departments, urgent care facilities, and physician office labs has the potential to provide swift and precise results, expediting clinical decision-making processes. This approach can help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, and ultimately enhance patient outcomes and healthcare system efficiency.(1-6)  

According to the U.S. Centers for Disease Control and Prevention (CDC), respiratory diseases in the United States reached high levels during the most recent autumn and winter seasons, with SARS-CoV-2 causing the most emergency department visits.(7) Hospitalizations due to respiratory illness place a strain on hospitals and can result in delayed diagnosis and treatment for patients.(8) In the 2023-2024 respiratory season, infants, children, and adults ages 65 and older were observed to have the highest rates of emergency department visits and hospitalizations caused by SARS-CoV-2, influenza and RSV.(9,10) Nationwide, the percentage of recent total deaths due to these respiratory viruses was highest among patients 65 and older.(11)

Further reading: Roche and ALZpath Partner on Alzheimer’s Blood Test

Roche’s Testing Portfolio

The cobas liat SARS-CoV-2, Influenza A/B & RSV -nucleic acid test authorized for emergency use further expands and complements Roche’s broad portfolio of single and multiplex tests intended to help diagnose and address the needs of patients presenting with symptoms of respiratory illness, including the following assays: cobas SARS-CoV-2, cobas Strep A, cobas SARS-CoV-2 & Influenza A/B, and cobas Influenza A/B & RSV for use on the cobas liat system. In 2025, Roche intends to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver in the United States for the new test, with plans for commercial launch in other markets worldwide following CE-IVDR approval.


  1. May L, Robbins EM, Canchola JA, Chugh K, Tran NK. 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. J Clin Virol. 2023;68:105597. doi:10.1016/j.jcv.2023.105597. 
  2. Hansen GT, Moore J, Herding E, et al. Clinical decision making in the emergency department setting using rapid PCR: Results of the CLADE study group. J Clin Virol. 2018;102:42-49. doi:10.1016/j.jcv.2018.02.013. 
  3. Berry L, Lansbury L, Gale L, Carroll AM, Lim WS. Point of care testing of Influenza A/B and RSV in an adult respiratory assessment unit is associated with improvement in isolation practices and reduction in hospital length of stay. J Med Microbiol. 2020;69(5):697-704. doi:10.1099/jmm.0.001187.
  4. Garvey MI, Wilkinson MAC, Bradley CW, Biggs M, et al. Impact of a PCR point of care test for influenza A/B on an acute medical unit in a large UK teaching hospital: results of an observational, pre and post intervention study. Antimicrob Resist Infect Control. 2019;16;8:120. doi:10.1186/s13756-019-0575-6.
  5. Patel P, Laurich VM, Smith S, Sturm J. Point-of-Care Influenza Testing in the Pediatric Emergency Department. Pediatr Emerg Care. 2020;36(11):515-518. doi:10.1097/PEC.0000000000002250. 
  6. Youngs J, Marshall B, Farragher M, et al. Implementation of influenza point-of-care testing and patient cohorting during a high-incidence season: a retrospective analysis of impact on infection prevention and control and clinical outcomes. J Hosp Infect. 2019;101(3):276-284. doi:10.1016/j.jhin.2018.11.010.
  7. Centers for Disease Control and Prevention. Public Health and Surveillance Data. RESP-LENS Interactive Dashboard. Accessed  May 28, 2024. 
  8. Centers for Disease Control and Prevention. Respiratory Illnesses. CDC Respiratory Virus Updates. Published January 12, 2024. Accessed January 24, 2024. 
  9. Centers for Disease Control and Prevention. Respiratory Illnesses. Groups Most Impacted—Emergency Department Visits. Published February 9, 2024. Accessed February 13, 2024. 
  10. Centers for Disease Control and Prevention. Respiratory Illnesses. Groups Most Impacted—Hospitalizations. Published February 9, 2024. Accessed February 13, 2024. 
  11. Centers for Disease Control and Prevention. Respiratory Illnesses. Groups Most Impacted—Deaths. Published May 24, 2024. Accessed May 28, 2024.