https://www.cdc.gov/csels/dls/locs/2021/
07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html
为避免争议所以我不缩网址 我英文很差用估狗翻译
07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing
07/21/2021：实验室警报：用于 SARS-CoV-2 测试的 CDC RT-PCR 的变化
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
After December 31, 2021, CDC will withdraw the request to the U.S. Food and
Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC
2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the
assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC
is providing this advance notice for clinical laboratories to have adequate
time to select and implement one of the many FDA-authorized alternatives.
2021 年 12 月 31 日之后，CDC 将撤回向美国食品药品监督管理局 (FDA) 提出的 CDC
2019-新型冠状病毒 (2019-nCoV) 实时 RT-PCR 诊断小组的紧急使用授权 (EUA) 请求，
即该检测于 2020 年 2 月首次引入，仅用于检测 SARS-CoV-2。CDC 正在向临床实验室提
供此提前通知，以便有足够的时间选择和实施 FDA 授权的众多替代方案之一。
Visit the FDA website for a list of authorized COVID-19 diagnostic methods.
For a summary of the performance of FDA-authorized molecular methods with an
FDA reference panel, visit this page.
访问 FDA 网站以获取授权的 COVID-19 诊断方法列表。有关 FDA 授权分子方法与 FDA
参考面板的性能摘要，请访问此页面。
In preparation for this change, CDC recommends clinical laboratories and
testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and
begin their transition to another FDA-authorized COVID-19 test. CDC
encourages laboratories to consider adoption of a multiplexed method that can
facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.
Such assays can facilitate continued testing for both influenza and
SARS-CoV-2 and can save both time and resources as we head into influenza
season. Laboratories and testing sites should validate and verify their
selected assay within their facility before beginning clinical testing.
为准备这一变化，CDC 建议一直使用 CDC 2019-nCoV RT-PCR 检测的临床实验室和检测点
选择并开始过渡到另一个 FDA 授权的 COVID-19 检测。CDC 鼓励实验室考虑采用多路复
用方法，以促进 SARS-CoV-2 和流感病毒的检测和区分。此类检测可以促进对流感和
SARS-CoV-2 的持续检测，并且可以在我们进入流感季节时节省时间和资源。在开始临床
测试之前，实验室和测试场所应在其设施内验证和验证他们选择的检测方法。