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FDA Grants Emergency Use Authorization for 4-in-1 Respiratory Diagnostic Test
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The 4-in-1 respiratory diagnostic test is either a single nasopharyngeal or anterior nasal swab that can confirm or rule out SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus with a single test.
The FDA has granted emergency use authorization (EUA) for the cobas liat SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV) nucleic acid test (Roche). The test is an automated, real-time polymerase chain reaction assay for the cobas liat system, producing results in approximately 20 minutes, according to a new release.1
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“Diagnostics play a critical role in the fight against respiratory illness,” Matt Sause, CEO of Roche Diagnostics, said in the release. “We are proud to provide this innovative test to address the significant burden placed on health care systems. Now, health care professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.”1
The test is either a single nasopharyngeal or anterior nasal-swab that can confirm or rule out SARS-CoV-2, influenza A virus, influenza B virus, and RSV with a single test. The test is for use for trained professional who are instructed in the use of cobas liat system and is only for use under the EUA. Positive results are indicative of the presence of diseases, but do not rule out bacterial infection or co-infection. Further, negative results do not preclude infection and should not be used as the sole basis for decision making, according to the news release.1
According to the CDC, from October 1, 2023, through June 1, 2024, there have been 35 to 64 million cases of the flu, 390-000 to 810,000 flu hospitalizations, and 24,000 to 71,000 flu-related deaths.2 The CDC also stated that respiratory disease activity was elevated in February 2024, with flu activity rising nationally. In some areas of the country, emergency department visits for flu have also increased.3
According to the Respiratory Virus Hospitalization Surveillance Network (RESP-NET), the combined rates of respiratory disease peaked in late December and declined through January, then spiked again in February and March. The rates of COVID-19 and influenza followed the same trends and RSV steadily declined.The rates of RSV and COVID-19 infections’ peaks are only slightly lower than the 2022-2023 season, but also peaked later in the year compared with the 2022-2023 season. For influenza, the rates peaked later and higher than the 2022-2023 season.4
Further, COVID-19 and the overall respiratory rates began to rise from July to September during the 2023-2024 season, according to the RESP-NET data.4
The RESP-NET does not collect data on all hospitalizations caused by respiratory illnesses, and includes 12 states for RSV, 13 for COVID-19, and 14 for Influenza. It is estimated to include approximately 8% to 10% of the United States population, according to the CDC.4
The CDC recommends that everyone aged 6 months and older received the influenza vaccination and COVID-19 vaccination. Further, infants, some young children, and pregnant individuals should be vaccinated for RSV routinely. Older adults are also recommended to receive an RSV immunization under clinical shared decision-making.5
