[fda.gov]

"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that LabCorp’s COVID-19 RT-PCR Test may be effective in diagnosing COVID-19, and that the known and potential benefits of the COVID-19 RT-PCR Test, when used for diagnosing COVID-19, outweigh the known and potential risks of such product; and"

"... COVID-19 RT-PCR Test is a qualitative test for the detection of nucleic acid from SARS-CoV-2..."

"Positive results do not rule out bacterial infection or coinfection with other viruses."

"To perform LabCorp’s COVID-19 RT-PCR Test, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from upper and lower respiratory specimens (such as nasal, nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate). The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized realtime (RT) PCR instrument.."

What is the degree of (number of) amplifications?

"FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, and concludes that LabCorp’s COVID19 RT-PCR Test, when used for qualitative detection of the SARS-CoV-2 in the specified population (as described in the Scope of Authorization of this letter (Section II)), meets the criteria set forth in Section 564 of the Act concerning safety and potential effectiveness."

[govinfo.gov]

I can't find "Section 564 of the Act" to find "criteria set forth" "concerning safety and potential effectiveness."

"I am waiving the following requirements for LabCorp’s COVID-19 RT-PCR Test during the duration of this EUA: • Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the COVID-19 RT-PCR Test "

Does that mean immunity from liability for "bad" (not good) manufacturing practice?

"Test have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate."

Again, what is the measure of accuracy for this test to be able to identify individual people who are infected with a specific virus (a virus not identified the standard Gold Standard way), and what are the percentage of false positives expected or known during the testing of this test?

"... may be effective...' means may not be effective.

It detects "nucleic acid from SARS-CoV-2", it does not therefore detect a specified microorganism (virus) such as the not yet found to exist COVID-19.

"Positive results do not rule out bacterial infection or coinfection with other viruses."

What are the consequences associated with a false positive test result?

" LabCorp will collect information on the performance of the test. LabCorp will report to FDA any suspected occurrence of false positive and false negative results and significant deviations from the established performance characteristics of the test of which LabCorp becomes aware."

What constitutes the data that leads to suspicion of false positive or false negative results?

"LabCorp may request changes to the Scope of Authorization (Section II in this letter) of the authorized COVID-19 RT-PCR Test. Such requests will be made by LabCorp in consultation with DMD/OHT7-OIR/OPEQ/CDRH, and require concurrence of, Office of Counterterrorism and Emerging Threats (OCET)/Office of the Chief Scientist (OCS)/Office of the Commissioner (OC) and DMD/OHT7-OIR/OPEQ/CDRH."

Is someone claimed to be infected a terrorist in need of Counterterrorism military deployment: "boots on the ground"?

"LabCorp may request the addition of other extraction methods for use with the authorized COVID-19 RT-PCR Test. Such requests will be made by LabCorp in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH."

What are "other extraction methods"?

[fda.gov]

"Serves as the FDA focal point for the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and Department of Defense medical countermeasure (MCM) programs to support the warfighter
Coordinates FDA’s Medical Countermeasures Initiative (MCMi) to facilitate the development of safe and effective MCMs against chemical, biological, radiological, and nuclear agents and emerging threats, such as pandemic influenza
Develops and coordinates implementation of FDA policies and procedures to facilitate the availability of MCMs, including efforts to safeguard MCMs from adulteration or disruption of supplies during public health emergencies, and enable access to available MCMs when necessary through an appropriate mechanism, such as Emergency Use Authorization."

"Department of Defense medical countermeasure (MCM) programs to support the warfighter"

[health.mil]
"Medical Countermeasures. The Director, HRP&O Medical Countermeasures (MCM) develops policies and guidance for MCM to protect U.S. forces against current and future chemical, biological, radiological, and nuclear (CBRN) threats and emerging infectious diseases."

"LabCorp will track adverse events associated with the authorized COVID-19 RT-PCR Test, including any occurrence of false results and report to FDA under 21 CFR Part 803."

"Test, including occurrences of false results and report to FDA under 21 CFR Part 803."

How does anyone know when a false positive or false negative result occurs when the symptoms can be attributable to many possible causes? Even so, what are the expected uncontroversial false positive or false negative results (no symptoms for false positive result over time and symptoms for false negative result over time), and what are the errors going to be over time, so as to then "learn from history?" Note here that previous "viruses" turned out not to be viruses, such as Polio for a prime example.

"LabCorp will submit to FDA a summary report within 30 calendar days of this letter summarizing the results of any testing performed using nasal specimens collected with the Pixel by LabCorp COVID-19 Test Home Collection Kit during that timeframe, including how many kits were requested and granted for home collection, how many kits were shipped and returned, how many specimens had to be rejected during accession and the main reasons for rejection, and the positivity rate of the first Pixel by LabCorp COVID-19 Test Home Collection Kit lot."

How is the "positivity rate" determined?

"Authorized laboratories will collect information on the performance of the test and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUAReporting@fda.hhs.gov) and LabCorp (covid19requests@labcorp.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the test of which they become aware."

Where are the "established performance characteristics of the test" found? Where is that data?

"This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens; and,
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(1) of the Act, 21 U.S.C. § 360bbb-3(1), unless the authorization is terminated or revoked sooner. "

It does not test for a virus, it tests for "nucleic acid from SARSCoV-2," which is "qualitative detection" of RNA amplified a number of times to "detect" a string of RNA associated with SARSCoV-2, so where is there any evidence of a new "Novel" virus?

This is classic "treat the symptom" dogma, known to be ineffective at best and damaging as a matter of demonstrated fact.

"No advertising or promotional descriptive printed matter relating to the use of LabCorp’s authorized COVID-19 RT-PCR Test may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2"

Bait and Switch?

"Sincerely, RADM Denise M. Hinton Chief Scientist Food and Drug Administration"