White House coronavirus adviser and longtime federal infectious disease expert Anthony Fauci was warned as early as March of 2020 that tests widely used to diagnose COVID-19 could suffer from high levels of false positive results, a problem that was confirmed by the World Health Organization earlier this year.
The warning was given in a Mar. 22, 2020 email to Fauci from Sin Hang Lee, the director of the Milford Molecular Diagnostics Laboratory in Milford, Conn. The message was part of a large batch of emails and other records recently obtained by Judicial Watch and the Daily Caller News Foundation.
In Lee's message, he warns Fauci and several other doctors: "It has been widely reported in the social media that the RT-qPCR test kits used to detect SARS- CoV-2 RNA in human specimens are generating many false positive results and are not sensitive enough to detect some real positive cases, especially during convalescence."
"Without a reliable laboratory diagnostic test, we are flying blind," he wrote.
Lee in the message summarizes a proposal contained in an "attached letter" that was not included in the email batch. The summary itself, however, was redacted from the released email.
Reached for comment, Lee provided Just the News with a copy of the original email. In the redacted portion, the scientist proposes "to adopt or to develop a routine nested RT-qPCR protocol to generate a 398 bp amplicon as the template for Sanger sequencing to raise the sensitivity and specificity of the tests."
Lee also shared the letter he enclosed to Fauci and the other physicians, in which — in addition to proposing the nested RT-qPCR protocol — he argues that RT-qPCR technology "is known to generate false positive results when used to detect influenza A virus and MERS-CoV, another Coronavirus."
He clarified to Just the News on Thursday that raising the sensitivity of a PCR test would weed out the detection of irrelevant genetic material that risks showing up as a positive result. "The current RT-qPCR does not verify what is being detected," he argued. "That is the cause of false positives."
Lee told Just the News that he "never received an acknowledgement from Dr. Fauci" about the letter.
"PCR is just like a Xerox copier that can make numerous copies of a specific segment of DNA for analysis," he told Just the News. "PCR was not invented as a diagnostic tool."
"The currently used RT-qPCR assays for SARS-CoV-2," he argued further, "are not PCR, strictly scientifically speaking. Just like a straitjacket is not a jacket."
Neither Fauci nor his staff responded to queries regarding the email.
The major medical supply company Thermo Fisher Scientific has referred to RT-qPCR tests as "the gold standard for COVID-19 testing." Yet significant questions have been raised in the past year about those tests' accuracy and reliability.
In July of last year, for instance, Fauci himself admitted that such tests have the potential to return a positive result when in fact the sample consists of simply "dead nucleotides" instead of live virus
In January, meanwhile, the World Health Organization issued a directive to medical providers warning them of potential false positives in PCR tests due to the method by which the tests amplify and detect viral samples.
Lee said current guidelines on COVID-19 testing allow for the "presumptive detection of SARS-CoV-2," while his proposed method would stipulate "definitive" detection.
"We are running the country on presumptive evidence," he said. "That is the problem."