First of its kind SARS-CoV-2 detection by partial N gene sequencing now publicly available at CLIA Certified Milford Connecticut laboratory
First of its kind SARS-CoV-2 detection by partial N gene sequencing now publicly available at CLIA Certified Milford Connecticut laboratory
Becomes the nation’s provider of Covid testing at highest level of accuracy
With reflex spike protein gene sequencing for K417N, K417T, L452R, S477N, E484K, E484Q, S494P and N501Y mutations
This routine DNA sequence electropherogram covering the ACE2 receptor binding domain shows 7 vertical black bars from left to right, pointing to 7 key nucleotides identified as A, G, T, G, A, T and A in the S gene of SARS-CoV-2 in a nasopharyngeal swab specimen taken from a patient with acute respiratory infection. The nucleotide A pointed by the 5th bar is a mutated base, indicating an E484K amino acid mutation (G>A nucleotide mutation). All other 6 black bars point to wildtype bases, confirming the lack of K417N, K417T, L452R, S477N, E484Q, S494P and N501Y mutations in this virus isolate. All known newly emerging SARS-CoV-2 variants of concern are associated with at least one of the 8 amino acid mutations identified in this sequence. Specimens harboring any of these 8 amino acid mutations will be further sequenced for A67V, Δ69/70, T95I, Δ144Y, Y145del, H146del, W152C and V1176F mutations for B.1.1.7, B.1.351, B.1.427, B.1.429, B.1.525, B.1.526, B.1.617, B.1.168, P.1 and P.2 variant differentiation. Timely recognition of B.1.617 and B.1.168 is especially important in view of the recent rising number of these two variants reported in India, said Dr. Sin Hang Lee, director of Milford Molecular Diagnostics Laboratory. (Photo: Business Wire)
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
Contacts
Media:
For Milford Molecular Diagnostics Laboratory, Milford, Conn.
Kevin Moore, 203-788-8497
