First good news Ive read in a while.. But why wait until December?
https://www.cdc.gov/csels/dls/locs/...-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html
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.
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https://www.fda.gov/medical-devices...CoV-2 Testing&deliveryName=USCDC_2146-DM61940
In Vitro Diagnostics EUAs
In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.
There are several types of SARS-CoV-2 and COVID-19 related IVDs:
Templates for EUA Submissions
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA:
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Anyway, I don't understand allot of the above.. But I do know that the PCR test run at 35 cycles is/was the grounds for the deception, lock downs and then inoculations.
Time will tell if testing facilities actually stop using the PCR test. Or has the CDC and WHO already achieved their agenda and are now just trying to cover their tracks?
https://www.cdc.gov/csels/dls/locs/...-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html
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.
==============================================
https://www.fda.gov/medical-devices...CoV-2 Testing&deliveryName=USCDC_2146-DM61940
In Vitro Diagnostics EUAs
In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.
There are several types of SARS-CoV-2 and COVID-19 related IVDs:
- Diagnostic Tests: Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
- Serology/Antibody and Other Adaptive Immune Response Tests: Tests that detect antibodies (for example, IgM, IgG) to the SARS-CoV-2 virus or that measure a different adaptive immune response (such as, T cell immune response) to the SARS-CoV-2 virus. These types of tests cannot be used to diagnose a current infection.
- Tests for Management of COVID-19 Patients: Beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions.
Templates for EUA Submissions
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA:
===============================================
Anyway, I don't understand allot of the above.. But I do know that the PCR test run at 35 cycles is/was the grounds for the deception, lock downs and then inoculations.
Time will tell if testing facilities actually stop using the PCR test. Or has the CDC and WHO already achieved their agenda and are now just trying to cover their tracks?