CDC coronavirus test kits generate 30% false positives and 20% false negatives
CDC’s current SARS-CoV-2 nucleic acid test kits generate 30% false positives and 20% false negatives in the state’s best public health laboratory, reported Dr. Sin Hang Lee in a peer-reviewed article published in the International Journal of Geriatrics and Rehabilitation, an online journal based in Japan (http://www.int-soc-clin-geriat.com/info/wp-content/uploads/2020/03/Dr.-Lees-paper-on-testing-for-SARS-CoV-2.pdf), July 17, 2020.
Sin Hang Lee, MD, director of the Milford Molecular Diagnostics Laboratory, author of the article (http://www.dnalymetest.com/images/IJGeriatRehabLee_on_SARSCoV2_test.pdf), retested 20 reference samples provided by the Connecticut State Department’s Microbiology Laboratory Division to arrive at this conclusion, according to the published article. These reference samples were tested by the State Microbiology Laboratory with the CDC test kit and used as a standard reference to guide local laboratories to develop their own tests for SARS-CoV-2 in clinical samples from patients suspected of COVID- 19, according to the published article titled “Testing for SARS-CoV-2 in Cellular Components by Routine Nested RT-PCR Followed by DNA Sequencing”.
Dr Lee is the first scientist to develop a protocol to test cellular components, instead of the cell-free fluid sample from a swab rinse, for SARS-CoV-2 genomic RNA.
“The virus has to grow and replicate in a living cell, and an infected cell can provide thousands of equivalent copies of the viral genome to be tested,” Dr Lee explained.
The Food and Drug Administration (FDA) requires 95% positive and negative agreement with reference samples for a laboratory-developed test to be acceptable in an application for a SARS-CoV-2 molecular diagnostic test to be performed under emergency use authorization (EUA). But the FDA also says that “false results can be investigated using additional EUA RT-PCR assay and / or Sanger sequencing.” This indicates that Sanger sequencing is a de facto gold standard in resolving test results based on discordant nucleic acids, Dr Lee said.
Using Sanger sequencing as a molecular validation tool, one of two false negative samples provided by Connecticut State Laboratory was found to contain a mutant with a new insertion of a single A nucleotide in the N gene and a SARS-CoV wild type parental. -2, indicating that a newly developed mutant and its parental virus can co-infect the same host, as illustrated in this N gene sequence published in the article.
One of nine SARS-CoV-2 positive isolates was found to be a recently discovered mutant first isolated from a sample collected in New York State on March 17, 2020, reports Dr. Lee in the article.
“Long-term care facilities with unusually high COVID-19 death rates among their residents and hospitals with active nose and throat surgery departments may need to install an extremely sensitive and sensitive Sanger sequencing test. very specific for SARS-CoV-2 to protect their residents, patients and staff, ”said Dr Lee.
According to Dr Lee, this manuscript was peer reviewed by 5 reviewers and two journal editorial boards before finally being accepted for publication through an open review process.
Dr Lee proposes to re-test residues of respiratory swab samples from deceased nursing home residents with unusually high death rates for SARS-CoV-2 with his protocol to investigate a possible link between the fake test results and the high rates of death from COVID-19 at these institutions, as widely reported in the media. Interested parties are encouraged to contact Kevin Moore.
See the source version on businesswire.com: https://www.businesswire.com/news/home/20200717005397/en/
For the Milford Molecular Diagnostic Laboratory, Milford, Conn.
Kevin Moore, 203-788-8497