Abbott Receives EUA for PCR Assay That Detects, Differentiates SARS-CoV-2, Flu, RSV in One Test

Abbott announced U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company's Alinity™ m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test. This test is CE Marked and available in countries outside the U.S.

The Alinity m Resp-4-Plex test can be conducted with one swab specimen (anterior nasal or nasopharyngeal) collected by a healthcare provider or an anterior nasal swab specimen self-collected at a healthcare location from individuals suspected by their provider of respiratory viral infection consistent with COVID-19. Alinity m uses Polymerase Chain Reaction (PCR) technology, which is known for its high sensitivity in detecting infectious diseases. To help fight the pandemic, Abbott has accelerated placements of the Alinity m system in hospital labs, academic centers and labs that are critical to patient care.

"Abbott has been developing and introducing tests that have been playing a critical role in fighting the pandemic. The need for a combination of testing methods in different settings has never been more clear," said Andrea Wainer, executive vice president, Rapid and Molecular Diagnostics, Abbott. "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 Alinity m Resp-4-Plex assay will be used to detect these four prevalent respiratory viruses. The advanced technology of the Alinity m system provides automation and on-demand access. This assay's ability to detect and differentiate these viruses simultaneously with only one swab will also ease the resource strain on collection devices, which have been in high demand throughout the COVID-19 pandemic.

Abbott is also announcing that the EUA for the company's Alinity m SARS-CoV-2 test has been updated to include an asymptomatic claim – detecting COVID-19 in individuals who do not have symptoms. A recent study found that more than 60% of COVID-19 infections present as asymptomatic cases, which is why it's critical to catch those cases before they spread. With the recent update to the Alinity m SARS-CoV-2 test EUA, the assay can now be used to detect individuals who are infected with SARS-CoV-2, but do not have symptoms or other reason to suspect COVID-19 infection. The Alinity m SARS-CoV-2 test EUA was also updated to include a pooling claim, which allows up to five samples to be tested at the same time. The updated Alinity m SARS-CoV-2 test, Alinity m Resp-4-Plex assay, and Abbott's existing testing technologies will now all be available to support front-line healthcare workers.

Assays available for use on the Alinity m system worldwide include: SARS-CoV-2, HCV (hepatitis C), HBV (hepatitis B), HIV-1 (human immunodeficiency virus type 1), STI (CT/NG/TV/MG) and HR HPV. The easy-to-use system will help to improve laboratory workflow and efficiency with its large capacity and fast turnaround time, being able to run up to 1,080 tests in a 24-hour period based on laboratory practice and workflow. Alinity m systems are designed to be more efficient – running more tests in less time and minimizing human errors – while continuing to provide quality results.