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On December 3, the Florida Department of Health announced a new update requiring all laboratories conducting COVID-19 tests to record new details for the polymerase chain reaction (PCR) test. The announcement came via an email update from the Medical Quality Assurance division of the Florida DOH addressed to all licensed health care practitioners.
The update, Mandatory Reporting of COVID-19 Laboratory Test Results: Reporting of Cycle Threshold Values, notes that all Florida "l aboratories are subject to mandatory reporting to the Florida Department of Health (FDOH)," including for "PCR, other RNA, antigen and antibody results." The update adds new requirements for the PCR test, asking labs to record the "cycle threshold" (CT) values for the process.
The PCR test uses chemicals to amplify the virus's genetic material and then each sample goes through a number of cycles until a virus is recovered. This "cycle threshold" has become a key component in the debate around the efficacy of the PCR test.
The FDOH document states (emphasis added):
"Cycle threshold (CT) values and their reference ranges, as applicable, must be reported by laboratories to FDOH via electronic laboratory reporting or by fax immediately. If your laboratory is not currently reporting CT values and their reference ranges, the lab should begin reporting this information to FDOH within seven days of the date of this memorandum."
The update asks labs who are unable to report CT values to fill out a questionnaire and submit it to the FDOH's Bureau of Epidemiology within 7 days.
The fact that the Florida Department of Health is taking this step is a sign that an increasing number of health professionals and regulators are questioning the accuracy of the PCR test. The PCR is the most common lab test being used to detect COVID-19. This incredibly sensitive technique was developed by Berkeley scientist Kary Mullis, for which he was awarded the Nobel Prize in 1993. The test is designed to detect the presence of a virus by amplifying the virus' genetic material so it can be detected by scientists. The test is viewed as the gold standard, however, it is not without problems.
On August 31, I attended a press conference in Houston and had a chance to ask Houston Health Authority Dr. David Persse about concerns around the test used to detect COVID-19. Dr. Persse said when the labs report numbers of COVID-19 cases to the City of Houston they only offer a binary option of "yes" for positive or "no" for negative.
"But, in reality, it comes in what is called cycle-thresholds. It's an inverse relationship, so the higher the number the less virus there was in the initial sample," Persse explained. "Some labs will report out to 40 cycle-thresholds, and if they get a positive at 40 - which means there is a tiny, tiny, tiny amount of virus there - that gets reported to us as positive and we don't know any different."
Persse noted that the key question is, at what value is someone considered still infectious?
"Because if you test me and I have a tiny amount of virus, does that mean I am contagious? That I am still infectious to someone else? If you are shedding a little bit of virus are you just starting? Or are you on the downside?," Dr. Persse asked in the lobby of Houston City Hall. He believes the answer is for the scientific community to set a national standard for cycle-threshold.
Unfortunately, the problems associated with the PCR test are international in scope.Problems in Portugal, the UK
On November 11, the Lisbon Court of Appeal ruled that the PCR test "is unable to determine, beyond reasonable doubt, that a positive result corresponds, in fact, to the infection of a person by the SARS-CoV-2 virus." The decision relates to an appeal by the Regional Health Administration of the Azores - officially the Autonomous Region of the Azores in Portugal - who forced four German citizens to comply with a 14 day quarantine in a hotel room.
After the four citizens appealed the decision, the panel of judges concluded that "the number of cycles of such amplification results in a greater or lesser reliability of such tests. And the problem is that this reliability shows itself, in terms of scientific evidence (") as more than debatable."
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