A blistering report Monday from CBS13 Sacramento reported thousands of inconclusive test results coming out of Gov. Gavin Newsom’s $100 million COVID-19 testing lab with the $1.7 billion contract with PerkinElmer. All of this expense was supposed to ramp up testing and processing, but the high number of false-positives were concerning.
The Globe reported on this lab in December, and spoke to a confidential source who shared concerns with the PCR tests. We also reported on three doctors in Contra Costa County who were concerned with the excessive COVID PCR testing leading to high numbers of false positive results. They wrote a letter of their concerns to county public health officer, Dr. Chris Farnitano. The result was not more information provided to the doctors, but instead, it was apparent someone from the government put pressure on John Muir Hospital where the three doctors worked – one of the doctors was terminated as the Medical Director of Trauma and Regional Transfer Services at John Muir, and we were told the other two doctors received reprimands.
The source explained about the high number of false positive PCR tests:
“Results from a positive PCR test should be considered as a preliminary result only and doesn’t determine an active infection or hospitalization rates. Doctors typically order these tests when a patient shows symptoms and the doctor suspects the patient has a high probability of having the disease. Once a result comes back positive, it must be confirmed with another test in order to be considered definitive.
The concern with Covid screening is that none of these steps are taken. A positive PCR has little clinical significance and increases our case numbers without confirming the presence of an active infection. Without the expertise of a physician and a confirmatory assay there is no way to determine if this is a true positive result.”
As the Globe recently reported, we know that Gov. Gavin Newsom and CHHS Secretary Dr. Mark Ghaly conflate positivity of coronavirus “cases” with actual illnesses to keep California in a state of panic and lockdown. A “case” is not a “case” unless someone is sick with the virus in the hospital, or has died as a result of COVID-19.
COVID-19 PCR Tests
Every PCR kit comes with a package insert that outlines the procedure as well as FDA recommended guidelines. PCR is not FDA approved for screening and results are only approved if an MD suspects Covid. PCR Covid kits are not approved for contact tracing, the source shared.
The source, who asked for anonymity, shared the Abbott labs PCR test insert which is included in every PCR test kit. “Notice the complexity of the procedure with risk of cross contamination. I’m not sure how sensitivity and specificity is maintained testing several thousand specimens/day. These procedures were never designed for the massive screening being done currently in CA.”
“PCR has been used by public health for 20 years, they are well aware of this limitation,” she said.
“Abbott Labs Package Insert on testing guidelines on their laboratory test for COVID-19 make it very clear there are limitations to the PCR test, and that a positive result must be evaluated by a trained professional, in conjunction with patient history, clinical signs and symptoms. It is apparent that Public Health agencies are not following the manufactures’ testing guidelines when they do community wide screenings, which puts these case numbers into further question and castes doubt on Newsom’s Blue Print.”
All of this adds up to an attempt to boost numbers and create an artificial hospital usage wave, likely for the purpose of continuing to govern California under a state of emergency.
Dr. Michael deBoisblanc, Dr. Pete Mazolewski and Dr. Brian Hopkins explain:
“PCR testing has proven to be seriously flawed when used to track disease prevalence, and the number of false positive tests has contributed to fear, panic and unnecessary quarantine of many. The peer review of the original Corman-Drosten PCR paper points out the serious flaws and conflicts of interest in the original article describing the PCR test (Peter Borger Et al., 11/27/2020). This paper is the basis for the PCR test used in the United States. On January 21, 2021 the World Health Organization published direction on the interpretation of a positive PCR test. They now caution about calling a test “positive” without symptoms, a confirmatory test, and physician oversight. They also cite the serious problems with high cycle thresholds leading to a high number of false positives. In short, they agree with what we argued last month.”
“With this information, your COVID positive case numbers are highly suspect and using this data to determine which tier the population falls into has been, and continues to be, completely unreliable and arbitrary. Our recommendation is to move forward quickly with rapid antigen testing. These tests are less expensive, and more appropriately sensitive to detect people with active, contagious disease.”
Maybe the three MDs got too close to the truth.
As for the inconsistencies at the lab, CBS13 interviewed more than half a dozen whistleblowers and obtained dozens of internal records and quality control reports:
The documents detail problems ranging from contamination causing inconclusive results to swapped samples and inaccurate results sent to patients.
Records indicate that employees handling patient specimens had not been signed off for competency on crucial skills. Documented competency is required under federal law.
Investigating California’s Billion-Dollar Lab
The state’s new $25 million lab and $1.7 billion contract with PerkinElmer was supposed to revolutionize COVID testing in California. PerkinElmer is contracted to process up to 150,000 COVID tests daily by March, returning results in 24 to 48 hours.
Records indicate they’re currently processing an average of fewer than 20,000 tests a day but, according to the state, are being paid the contracted rate for 100,000 tests per day.
California State Senator Melissa Melendez (R- Lake Elsinore) responded to whistleblower allegations at California’s funded COVID lab:
“As the Vice-Chair of the Senate Health Committee I find the allegations regarding the failures at the State’s new, billion dollar, COVID lab concerning and downright shameful. Millions of Californians rely on the accuracy of these tests. The mistreatment of COVID test samples jeopardizes the health and safety of over 40 million Californians. Considering the lack of transparency surrounding the ‘science’ that is the basis for the stay at home orders and for shutting down businesses, I hope the administration and the California Department of Public Health come forward with real answers to what is happening at our testing facilities. I will be calling for a full investigation into this matter and hope my majority party colleagues in the State Senate will join me in this search for the truth behind these allegations.”
CBS13 found through the whistleblowers that lab employees were untrained and unlicensed. Some slept on the job, while others were careless with testing materials.
CBS13 received a response from a representative from the California Health and Human Services Agency:
“We are troubled by these allegations against our laboratory vendor and its employees and will investigate them immediately and thoroughly. If these claims are substantiated, they would represent a clear violation of our existing agreement with PerkinElmer and we would take swift action to fix these issues, up to and including termination of the contract.
“This lab was established by the state to provide accurate test results for the people of California as quickly as possible.”
Dr. Michael deBoisblanc, Dr. Pete Mazolewski and Dr. Brian Hopkins followed up with Contra Costa County. In the latest letter, the doctors want answers they have not yet received, including about the PCR tests’ false positives.
“We write this letter in follow up to our previous letter dated December 10, 2020. In that letter we asked several questions regarding the following issues: PCR testing, and how the county was accounting for false positives?”
Is anything about the COVID-19 virus true, or is this the biggest political manipulation this country has ever seen?