The Lyra Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time
Quidel, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has applied for an Emergency Use Authorization (EUA) for the Lyra® Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing. The assay will be run on the same six different instruments as the Lyra® SARS-CoV-2 Assay.
Lyra Direct Removes RNA Extraction Processing Step, Removes Supply Bottleneck
Under the new EUA, the Lyra® Direct SARS-CoV-2 Assay no longer requires an upfront sample extraction.
The Lyra® Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time.
The assay retains its versatility in that it is still capable of running on any of six thermocyclers (Applied Biosystems 7500 Standard®, Applied Biosystems 7500 Fast®, Bio-Rad CFX96 Touch®, Qiagen Rotor-Gene Q®, Roche LightCycler® 480, and Thermo Fisher QuantStudio 7 Pro®).
Quidel is manufacturing approximately 500,000 tests per week and has begun shipping the improved product to its customers. The assay is currently available for sale in the United States while under EUA review. The Lyra® Direct SARS-CoV-2 Assay can be purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative.
Source: Company Press Release