California headquartered Quidel Corporation, a leading manufacturer of diagnostic healthcare products, has reportedly announced that the company’s latest Lyra® SARS-CoV-2 Assay has received the extended EUA (Emergency Use Authorization) claims from the U.S. FDA to facilitate testing with three other thermocyclers namely, Roche LightCycler 480, Qiagen Rotor-Gene Q and Applied Biosystems 7500 Standard.
Reportedly, the novel solution comprises of unique features that render simplified transportation and storage, reduced time to results, enhanced workflow and many other benefits that positively affect the diagnostic resultants. The Lyra® SARS-CoV-2 Assay facilitates many more advantages compared to other tests present in the market to monitor COVID-19.
Initially, under the Emergency Use Authorization, the latest coronavirus test kit was developed for the qualitatively detecting nucleic acid from SARS-CoV-2 in oropharyngeal and nasopharyngeal swabs testing from patients suspected of coronavirus by their healthcare providers.
For the record, the Centers for Disease Control and Prevention has expanded the list of acceptable specimens for including nasal & nasal turbinate swabs. However, the testing is restricted to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988. The authorization facilitates the early availability of crucial diagnostic tools if alternative tools are not enough.
The Lyra® SARS-CoV-2 Assay also received the CE-Mark which allows the company to market and sell the solution across Europe and other countries that accept the CE Mark. On 25 March 2020, Quidel Corporation accepted authorization from Health Canada to market and distribute the assay across Canada.
Apparently, the Lyra® SARS-CoV-2 Assay is presently available for sale in the U.S. under the EUA and may be purchased by a laboratory professional directly from Quidel or their Cardinal Health representative.
Quidel Corporation works to improve the healthcare offerings and the well being of people, worldwide, through the development of advanced diagnostic solutions that may lead to enhanced patient outcomes and by providing economic benefits to the vast healthcare infrastructure.