https://www.cdc.gov/csels/dls/locs/2021/
07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html
為避免爭議所以我不縮網址 我英文很差用估狗翻譯
07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing
07/21/2021：實驗室警報：用於 SARS-CoV-2 測試的 CDC RT-PCR 的變化
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 日之後，CDC 將撤迴向美國食品藥品監督管理局 (FDA) 提出的 CDC
2019-新型冠狀病毒 (2019-nCoV) 實時 RT-PCR 診斷小組的緊急使用授權 (EUA) 請求，
即該檢測於 2020 年 2 月首次引入，僅用於檢測 SARS-CoV-2。CDC 正在向臨床實驗室提
供此提前通知，以便有足夠的時間選擇和實施 FDA 授權的眾多替代方案之一。
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.
訪問 FDA 網站以獲取授權的 COVID-19 診斷方法列表。有關 FDA 授權分子方法與 FDA
參考面板的性能摘要，請訪問此頁面。
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.
為準備這一變化，CDC 建議一直使用 CDC 2019-nCoV RT-PCR 檢測的臨床實驗室和檢測點
選擇並開始過渡到另一個 FDA 授權的 COVID-19 檢測。CDC 鼓勵實驗室考慮採用多路復
用方法，以促進 SARS-CoV-2 和流感病毒的檢測和區分。此類檢測可以促進對流感和
SARS-CoV-2 的持續檢測，並且可以在我們進入流感季節時節省時間和資源。在開始臨床
測試之前，實驗室和測試場所應在其設施內驗證和驗證他們選擇的檢測方法。