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.

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.

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.

 

 

 

CDC press release /21Jul2021

Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing
CDC - OPHSS - CSELS - Division of Laboratory Systems (DLS)
www.cdc.gov
 

 

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村松社長

旅行産業界に身を置いてはや45年。シンガポール航空社の日本でのB２Bリーディングカンパニーから京都の制御機器メーカー傘下旅行社を経て起業して以来早くも28年目に入りました。このコロナ禍で本当の旅行情報を発信するために旅行WEBマガジンを令和3年に立ち上げる。専門は海外の出張など。趣味：散歩ついでのお地蔵さん・神社お詣り、銭湯巡り、落語鑑賞、映画鑑賞。

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