April 1, 2020
Quidel Corporation, a provider of point-of-care tests for dry eye and conjunctivitis and other rapid diagnostic testing solutions, has received expanded Emergency Use Authorization (EUA) claims from the Food and Drug Administration (FDA) to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.1
Acceptable Specimens Expanded to Include Nasal and Nasal Turbinate Swabs
Under the initial EUA, the Lyra SARS-CoV-2 Assay real-time RT-PCR test was intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 by their health-care provider.
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The list of acceptable specimens has been expanded by the CDC to include nasal and nasal turbinate swabs. 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. EUAs allow for the early availability of important diagnostic tools “when there are no adequate, approved and available alternatives.”2
The Lyra reagents include unique features that provide for simple transport and storage, improved workflow, shorter time to result, and other benefits that favorably affect diagnostic test outcome. The Lyra SARS-CoV-2 Assay provides these and certain additional advantages over many other tests currently on the market for this novel coronavirus, including easier set-up and faster time to result.
Quidel Receives CE Mark, Health Canada Authorization Separately, the Lyra SARS-CoV-2 Assay received CE-Mark on March 25, 2020. The CE Mark allows Quidel to market and sell the Lyra SARS-CoV-2 Assay in Europe, as well as other countries that accept the CE Mark. Also, on March 25, 2020, Quidel received authorization from Health Canada to market and sell the assay in Canada. The assay is currently available for sale in the U.S. under EUA and can be purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative.
References
i. Applied Biosystems®, LightCycler® 480, and Rotor-Gene® are registered trademarks of their respective owners.
ii. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
