快速生产并免费分发合成 RNA 材料，以支持 SARS-CoV-2 分子诊断检测。

Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing.

机构信息

National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, MD, 20899, USA.

出版信息

Biologicals. 2023 May;82:101680. doi: 10.1016/j.biologicals.2023.101680. Epub 2023 May 3.

DOI:10.1016/j.biologicals.2023.101680

PMID:37178559

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10154543/

Abstract

In response to the COVID-19 pandemic, the National Institute of Standards and Technology released a synthetic RNA material for SARS-CoV-2 in June 2020. The goal was to rapidly produce a material to support molecular diagnostic testing applications. This material, referred to as Research Grade Test Material 10169, was shipped free of charge to laboratories across the globe to provide a non-hazardous material for assay development and assay calibration. The material consisted of two unique regions of the SARS-CoV-2 genome approximately 4 kb nucleotides in length. The concentration of each synthetic fragment was measured using RT-dPCR methods and confirmed to be compatible with RT-qPCR methods. In this report, the preparation, stability, and limitations of this material are described.

摘要

针对 COVID-19 大流行，美国国家标准与技术研究院于 2020 年 6 月发布了用于 SARS-CoV-2 的合成 RNA 材料。其目的是快速生产一种用于支持分子诊断测试应用的材料。这种材料被称为研究级测试材料 10169，免费分发给全球各地的实验室，为测定法开发和测定法校准提供一种非危害性材料。该材料由 SARS-CoV-2 基因组的两个大约 4kb 核苷酸长的独特区域组成。使用 RT-dPCR 方法测量每个合成片段的浓度，并确认其与 RT-qPCR 方法兼容。本报告介绍了该材料的制备、稳定性和局限性。