log in

#lab

690 results found
Lab Alert:
Changes to CDC RT-PCR
for SARS-CoV-2 Testing
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.
00
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.
Opt in to receive updates from the CDC Laboratory Outreach Communication
System (LOGS).
Online resources:
it
of
Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing 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. 00 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. Opt in to receive updates from the CDC Laboratory Outreach Communication System (LOGS). Online resources: it of