MILFORD, Conn.--(BUSINESS WIRE)--Sin Hang Lee, MD, director of Milford Molecular Diagnostics Laboratory, announced today that his CLIA-certified laboratory has been granted a permit to perform diagnostic testing for SARS-CoV-2 by nested RT-PCR followed by DNA sequencing on nasopharyngeal swab samples and residues of RNA extracts previously tested by RT-qPCR assays. The CLIA certification was officially granted on April 29, 2021 through the State of Connecticut’s Department of Public Health. Milford Molecular Diagnostics Laboratory now becomes the sole CLIA certified laboratory in the nation to offer COVID-19 RNA testing at this level of accuracy to the general public.
“This test is for individuals who need definitive molecular diagnosis of SARS-CoV-2 infection and want to know if the infection is caused by one of the newly emerging virus variants of concern. While a few laboratories are selecting only samples with high viral loads for variant identification by sequencing, Milford Molecular Diagnostics Laboratory routinely sequences all positive samples by the Sanger method. The Sanger method not only can determine key mutations in samples with low viral load, but also can eliminate PCR false-positive results,” said Dr. Lee.
Acceptable test materials are nasopharyngeal swab specimens in virus transport media and RNA extract residues of previously tested samples. Patients and health care providers interested in submitting samples for testing may download a requisition form at Milford Molecular Diagnostics Laboratory’s website. Click on http://www.dnalymetest.com/images/Requisition_V2_Form_2021_Covid.pdf for further details.
Expected turnaround time for this test is three business days after receipt of samples, said Dr. Lee.
Nested RT-PCR amplification of a unique genomic RNA followed by Sanger sequencing of the cDNA amplicon is the most accurate molecular assay for SARS-CoV-2 in clinical specimens, said Dr. Lee.
“This is because the computer-generated sequencing data are verified with GenBank BLAST reports and the nested PCR can detect SARS-CoV-2 in clinical samples with very low viral loads that RT-qPCR assays may miss,” he explained.
The testing method was developed at Milford Molecular Diagnostics Laboratory and has been published in articles accessed through these links: http://www.int-soc-clin-geriat.com/img/top/Dr.-Lees-paper-on-testing-for-SARS-CoV-2_0402.pdf and https://www.dovepress.com/partial-n-gene-sequencing-for-sars-cov-2-verification-and-pathway-trac-peer-reviewed-fulltext-article-IMCRJ