Quidel以更快的运行速度赢得EUA的COVID-19测试

Quidel Corp. (NSDW:QDEL) announced that it received 美国食品药品管理局 emergency use authorization (EUA) for its 索拉纳 SARS-CoV-2 assay.

圣地亚哥的Quidel’s 索拉纳 SARS-CoV-2 assay is an isothermal reverse transcriptase-helicase-dependent amplification (RT-HDA) assay designed for the qualitative detection of nucleic acid from the virus causing 新冠肺炎 in nasopharyngeal and nasal swab specimens, according to a news release.

Testing with the 索拉纳 assay is limited to CLIA-certified laboratories for performing high and moderate-complexity tests, Quidel noted.

索拉纳’其功能包括：简单的工作流程，无需提取样品；专为批量测试和效率而量身定制的中等通量设计；运行25分钟，最多可提取11个样品。它客观地测量和解释荧光信号，在其显示屏上向用户报告测试结果，并可以通过集成打印机将结果打印出来。

台式仪器包括用于输入数据的交互式触摸屏和条形码扫描仪，以及用于数据传输，打印和与Dymo Label Writer系统兼容的以太网和USB端口。

“With so many of our nation’s laboratories overwhelmed by demand for 新冠肺炎 tests and under pressure to produce more timely results, there is a compelling societal need for the throughput and quick runtime offered by our new 索拉纳 molecular testing technology,” Quidel president & CEO Douglas Bryant 说过 in the news release. “Joining our Lyra and Lyra Direct assays for SARS-CoV-2, we now offer another molecular weapon in the fight against 新冠肺炎 to quickly diagnose symptomatic patient populations. The 索拉纳 SARS-CoV-2 Assay nicely complements our Sofia and QuickVue tests that are run at the point-of-care, for pre-symptomatic, asymptomatic and symptomatic patients.

“We are pleased to bring the benefits of our proprietary RT-HDA technology to detect 新冠肺炎 to the marketplace and further democratize access to testing across the country. 索拉纳 is a powerful diagnostic solution at a critical time.”