Abbott has secured an FDA authorization for a high-throughput laboratory test that screens for four respiratory viruses from a single swab sample: COVID-19, influenza A and B, and respiratory syncytial virus.
Though social distancing and masking efforts have had the added benefit of a hampered flu season compared to previous years, it’s still important to streamline the diagnostic process and detect the correct disease when a patient displays a cough, fever and fatigue.
The Resp-4-Plex molecular assay, designed for its Alinity m analyzers, joins a separate PCR test made solely for COVID-19—which the FDA recently granted expanded use for screening people who have not shown any symptoms of the pandemic disease.
Abbott estimated that more than 60% of cases may be asymptomatic. The diagnostic’s authorization was also updated by the agency to allow for the testing of pooled samples, enabling the screening of five people at once while conserving resources.
Together, the two tests support a strategy of catching a wider range of cases, and to distinguish COVID-19 infections from seemingly similar diseases.
"The need for a combination of testing methods in different settings has never been more clear," said Andrea Wainer, Abbott’s executive vice president of rapid and molecular diagnostics. "This newest test will allow for fast and efficient diagnosis and triage of patients who present with respiratory symptoms so they can be given the right care."
The four-way test will also help ease the strain on sample collection and preparation devices, the company said. The Resp-4-Plex assay previously received a CE mark and is available outside of the U.S.