Lab ALERT - CDC reports - RT-PCR Test is INVALID.
07/21/2021: 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.
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.
Opt in to receive updates from the CDC Laboratory Outreach Communication System (LOCS).
Online resources:
- FAQ: CDC Distribution of COVID-19 Assays
- Guidance for SARS-CoV-2 Point-of-Care Testing
- Interim Guidance for SARS-CoV-2 Antigen Testing
- Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19
- Frequently Asked Questions about COVID-19 for Laboratories
- Information for Laboratories about COVID-19
- CDC COVID-19 Website
- Clinical Laboratory COVID-19 Response Weekly Calls
- CDC Laboratory Outreach Communication System (LOCS)
If you have any questions, please contact us at LOCS@cdc.gov.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)
www.cdc.gov/csels/dls/locsPage last reviewed: July 19, 2021Content source: Division of Laboratory Systems (DLS)homeDLS Home
- About Usplus icon
- LIVD Mapping Tool for SARS-CoV-2 Tests
- Strengthening Clinical Laboratories
- CDC’s Laboratory Outreach Communication System (LOCS)plus icon
- Laboratory Communicators’ Networkplus icon
- Free Educational Materials for Public Health and Clinical Laboratories
- Competency Guidelines for Laboratory Professionals
- CDC Biorepository
- Biological Risk Assessment: General Considerations for Laboratories
- Lab Weekplus iconGet Email Updates
To receive email updates about this page, enter your email address:Email AddressWhat's this?SubmitRelated Links
- Clinical Laboratory Improvement Amendments (CLIA)
- Laboratory Training
- Biosafety
- Laboratory Medicine Best Practices (LMBP)
- Clinical Laboratory Improvement Advisory Committee (CLIAC)
COPYRIGHTS
Copy & Paste the link above for Yandex translation to Norwegian.
WHO and WHAT is behind it all ? : >
The bottom line is for the people to regain their original, moral principles, which have intentionally been watered out over the past generations by our press, TV, and other media owned by the Illuminati/Bilderberger Group, corrupting our morals by making misbehavior acceptable to our society. Only in this way shall we conquer this oncoming wave of evil.
Commentary:
Administrator
HUMAN SYNTHESIS
All articles contained in Human-Synthesis are freely available and collected from the Internet. The interpretation of the contents is left to the readers and do not necessarily represent the views of the Administrator. Disclaimer: The contents of this article are of sole responsibility of the author(s). Human-Synthesis will not be responsible for any inaccurate or incorrect statement in this article. Human-Synthesis grants permission to cross-post original Human-Synthesis articles on community internet sites as long as the text & title are not modified