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March 8, 2021

FDA grants EUA to Abbott’s assay to identify virus types

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Abbott’s Alinity m Resp-4-Plex molecular assay for detecting and distinguishing SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) in a single test. 

The US Food and Drug Administration (FDA ) has granted emergency use authorisation (EUA) to Abbott ’s Alinity m Resp-4-Plex molecular assay for detecting and distinguishing SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) in a single test.

The assay can test for four viruses that show symptoms but need different treatment approaches with one swab, which saves much-needed testing supplies.

It can be carried out with a single anterior nasal or nasopharyngeal swab specimen collected by a healthcare professional or self-collected anterior nasal swab specimen at a healthcare site from people suspected of Covid-19 by their provider.

Alinity m Resp-4-Plex molecular assay runs on Abbott ’s high-volume laboratory molecular instrument, Alinity m system, which uses polymerase chain reaction (PCR) technology.

The system helps to enhance laboratory workflow and efficiency with its large capacity and rapid turnaround time and can run up to 1,080 tests in 24 hours.

Abbott Rapid and Molecular Diagnostics executive vice-president Andrea Wainer said: “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.”

“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 company also noted that the EUA for its Alinity test was updated to include asymptomatic testing. It can now be used to identify people without Covid-19 symptoms or other reason to suspect an infection.

According to a new study, more than 60% of Covid-19 infections are asymptomatic, which is why it is essential to detect such cases before they spread.

In addition, the test EUA is updated to include a pooling claim, which enables the testing of up to five samples simultaneously.

The CE-marked test is currently available in countries outside the US.

In January, Abbott received CE Mark for its Panbio COVID-19 Ag Rapid Test Device to detect SARS-CoV-2 virus for two new uses of asymptomatic testing and self-swabbing.

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