在台湾建立 SARS-CoV-2 RNA 核酸扩增技术（NAAT）国家标准的合作研究。

Division of Research and Analysis, Taiwan Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 11561, Taiwan, ROC.

Biologicals. 2022 Sep;79:31-37. doi: 10.1016/j.biologicals.2022.08.002. Epub 2022 Aug 31.

The conventional PCR remains a valuable method to detect the newly emergent coronavirus rapidly and accurately. Our investigation aimed to establish the standard materials of SARS-CoV-2 for NAAT detection. We provided formalin-inactivated SARS-CoV-2 and confirmed RNA copy numbers. In addition, the virus genome was confirmed with whole-genome sequencing and identified as Wuhan/WI04/2019. Seven laboratories were invited for this collaborative study, according to the reporting data, we determined the SARS-CoV-2 with the unit of 6.35 Log copies/mL as the national standard. The availability of the national standard (NS) of SARS-CoV-2 will facilitate the standardization and harmonization of SARS-CoV-2 NAAT assays.

传统的 PCR 仍然是快速准确检测新出现的冠状病毒的一种有价值的方法。我们的研究旨在为 NAAT 检测建立 SARS-CoV-2 的标准物质。我们提供了福尔马林灭活的 SARS-CoV-2 和确认的 RNA 拷贝数。此外，通过全基因组测序确认了病毒基因组，并鉴定为武汉/WI04/2019。根据报告的数据，我们邀请了 7 个实验室参加这项合作研究，我们将拷贝数为 6.35 Log 拷贝/mL 的 SARS-CoV-2 确定为国家标准。SARS-CoV-2 国家标准（NS）的可用性将促进 SARS-CoV-2 NAAT 检测的标准化和协调。