A report has found that the federal Centers for Disease Control and Prevention’s nucleic acid test kits for SARS-CoV-2 has generated 30% false-positive and 20% false-negative results in testing conducted at the Connecticut State Department of Public Health Microbiology Laboratory Division.
The author of a peer-reviewed article published in the International Journal of Geriatrics and Rehabilitation, Dr. Sin Hang Lee, director of Milford Molecular Diagnostics Laboratory, said 20 reference samples provided by the state lab were retested for the study, which found multiple inaccuracies in the original test results.
Lee has offered to retest the residues of the respiratory swab samples of the deceased residents from nursing homes with high fatality rates attributed to the pandemic, in order to determine if there is a potential link between the inaccurate test results and the higher-than-normal COVID-19 death tolls within these facilities.
Lee is developing a protocol designed to test cellular components for SARS-CoV-2 genomic RNA instead of the cell-free fluid sample of a swab rinse that is widely used in COVID-19 testing. Lee advocated the use of Sanger sequencing ”“ a method for determining the nucleotide sequence of DNA ”“ to confirm the accuracy of previous testing.
“The virus must grow and replicate in a living cell, and one infected cell may contribute thousands of copies of viral genome equivalents to be tested,” explained Lee. “Long-term care facilities with exceptionally high COVID-19 death tolls among their residents and hospitals with active nose-and-throat surgery departments may need to install an extremely sensitive and highly accurate Sanger sequencing-based test for SARS-CoV-2 to protect their residents, patients and staff.”
