緊急授權新冠病毒檢測試劑之檢驗效能評估

The Performance of the Commercial Emergency Use Authorization Test for Detection of SARS-COV-2

新型冠狀病毒所引發的全球大流行，引起針對此疾病診斷所需快速且準確分子檢驗方法的大量需求。新冠病毒基因序列已被解析公佈，而針對其病毒核酸序列設計探針並以即時定量反轉錄鏈鎖反應方法進行檢測，是目前進行 COVID-19 確診之標準檢驗方法。為確保當疫情爆發時能快速核發大量且正確之檢驗報告，因此利用自動化分子檢驗平台搭配美國食藥局緊急授權使 用之新冠檢驗試劑，執行檢驗方法效能評估。

The pandemic coronavirus disease 2019 (COVID‐19) has created the need for rapid and accurate diagnostic manners. The primer and probe were designed based on the published genomic sequences for accurately detected SARS-CoV-2 virus by qRT-PCR as standard mode for diagnosis. Ensure timely and accurately reporting data when handling large numbers of samples is in need. In this study we report the analytical evaluation of the commercial Emergency Use Authorization (EUA) test approved from the Food and Drug Administration (FDA) for the detection of SARS-CoV-2 using the fully automatic system.