“This is a big deal – because unless most people are actively infected with SARS-CoV-2, the overwhelming number of test results will be false positives – even with test specificity as high as 99%.“
WHEN CDC’s DEADLY, FAILED TEST was found to be flawed, the HHS opened up the market to US companies to develop and sell tests for the SARS-CoV-2 virus, the virus that causes COVID19. FDA failed to require adequate evidence on false positive rates, and now FDA has stopped requiring pre-market review of new tests for COVID19.
The net effect of a series of bad policy decisions associated with the process of awarding Emergency Use Authorizations, FDA, and now HHS, have opted for perpetual, arbitrary COVID19 diagnosis.
First, FDA failed to require experimental evidence of false positive rates. FDA has no data on the ability of these tests to avoid leading to a false diagnosis of COVID19. Instead, FDA accepted assurances that the PCR kits theoretically should not lead to false positive results.
Last month, FDA published evaluation data of tests requested from companies that had and were seeking EUA. The evaluation data required were restricted to test sensitivity, the ability of the test to detect the virus in samples in which they should.
This is utterly confusing because it is unnecessary.
In January – that’s right JANUARY, Germany had already developed a test, adopted by 141 countries in January, that had been tested for sensitivity, specificity AND for pathogen specificity – the ability of the test to not lead to a false detection of SARS-CoV-2 in samples w/respiratory pathogens other than COVID19.
The record on CDC’s Deadly Flawed Test is established, and yet the US government points to China withholding information as the reason for the first wave hitting the US so fast and so hard. Yet China also did not provide that information to Germany, so how did Germany develop a robust test?
Now, in a series of stunning decisions, FDA has decided to cease consideration of any new testing kits – even those that were in process. This in wake of evidence from Dr. Sin Han Lee’s laboratory in Millford, CT that reference samples sent to labs to validate their kits themselves had a stunning percentage of false negatives…. and false positives (See Businesswire: CDC Coronavirus Test Kits Generate 30% False Positive and 20% False Negative Results – Connecticut Pathologist’s Newly Published Findings Confirm .
The layers of what’s wrong with CDC’s, FDA’s and HHS’s missteps in our nation’s responses to COVID19 include the allowance of the use of a positive COVID19 test as a proxy diagnosis for COVID19. COVID19 is the disease caused by SARS-CoV-2. People with no symptoms do not have “disease”.
The three-letter agency responses also, importantly, includes a tone-deafness to the massive societal cost stemming from each and every false positive test. False positive tests take a minimum of 10-14 days out of not only each false diagnosee, but also anyone who was in contact with them.
This is a big deal – because unless most people are actively infected with SARS-CoV-2, the overwhelming number of test results will be false positives – even with test specificity as high as 99%.
Dr. Lee’s test has a final step not used by the other tests – specifically, the PCR product resulting from the PCR reaction is actually sequenced – validating the results of the test as successfully amplifying the target sequence – COVID19 sequence – not human DNA or other pathogen nucleotide sequence.
I predicted in February that this would all come down to test flaws in the US. Every day that goes by in the US with businesses and schools being shut down over false positives we move closer and closer to anarchy and chaos.
The followings steps are necessary:
Read Dr. Lee’s Study: LINK
(1) FDA should demand Sanger sequencing confirmation of each and every test on reference samples spiked with SARS-CoV-2 target sequences – as conducted by Germany in January 2020 as new evidence of sensitivity. They should ALSO require demonstration of specificity in reference samples that do not contain any SARS-CoV-2 target sequences. They must immediately revoke the EUA of tests that fail these validation tests.
(2) Diagnosis of COVID19 – including case counting – should not be based on a positive SARS-CoV-2 PCR test. The tests are described as ‘too sensitive’ – but that’s false- the problem is too many false positives. Diagnosis of COVID19 should require symptoms as manifest evidence of disease for counting cases and deaths. National estimates of infection case fatality rates (IFCR) should be determined after being adjusted with data from a study of 1,000 random autopsies of people with and, and 1,000 without comorbidities who have died with a positive COVID19 test result to allow evidence-based estimates.
Watch my interview of Dr. Lee on Unbreaking Science:
Watch “CDC’s Deadly Testing Fiasco” on Unbreaking Science
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