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The US Food and Drug Administration (FDA) has granted expanded emergency use authorisation (EUA) for Quidel’s Lyra SARS-CoV-2 Assay for the coronavirus (Covid-19) diagnosis.
The expanded EUA will enable testing with three additional thermocyclers – Applied Biosystems 7500 Standard, Roche LightCycler 480 and Qiagen Rotor-Gene Q.
The initial EUA allowed the Lyra SARS-CoV-2 assay real-time RT-PCR test to qualitatively detect nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of Covid-19 by their healthcare provider.
Recently, the Centers for Disease Control and Prevention (CDC) expanded the list of acceptable specimens to include nasal and nasal turbinate swabs.
The FDA grants EUA to enable the early availability of important diagnostic tools when there are no adequate, approved and available alternatives.
The Lyra reagents are characterised by features that allow simple transport and storage, enhanced workflow, quicker results and other benefits that positively affect the diagnostic test outcome.
The test also provides certain additional advantages, including easier set-up and faster test results compared to other tests currently on the market for the coronavirus.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high-complexity tests.
Meanwhile, the Lyra SARS-CoV-2 Assay received CE-Mark, allowing its market launch in Europe and other countries.
Quidel also obtained authorisation from Health Canada to market and sell the assay in Canada. The assay is currently available for sale in the US under the EUA.