Sin Hang Lee, MD, director of Milford Molecular Diagnostics Laboratory announced today that his high complexity CLIA-certified laboratory is offering a diagnostic test directly to patients and their healthcare providers, a test that can determine all known COVID-19 variants of concern and interest, including the Omicron and Delta strains, the most predominant strains in the United States. Milford, Connecticut based Molecular Diagnostics Laboratory is believed to be the only laboratory in the United States offering this test directly to patients and their health care providers.
Dr. Lee explained, “As advised by the Centers for Disease Control and Prevention, now individuals can get a swab and a tube of preserve fluid from their healthcare provider or a testing center to self-collect a nasopharyngeal swab sample, and simply mail the sample to a testing laboratory for SARS-CoV-2 testing.”
For instructions on how to collect and send a sample, see https://www.cdc.gov/coronavirus/2019-ncov/testing/How-To-Collect-NMT-Specimen-for-COVID-19.pdf.
The development and technology of this test is based on an article Dr. Lee recently published in the medical journal, Viruses, titled, “A Routine Sanger Sequencing Target Specific Mutation Assay for SARS-CoV-2 Variants of Concern and Interest,” https://www.mdpi.com/1999-4915/13/12/2386/htm, according to the 3 target mutation sequences listed as follows.
WHO Name
|
Pango lineage |
ACE2 RBD mutations |
NTD mutations |
N-gene
|
Alpha |
B.1.1.7 |
N501Y |
69del, 70del,
|
N. A. |
Beta |
B.1.351 |
K417N, E484K, N501Y |
D80A |
N. A. |
Gamma |
P.1 |
K417T, E484K, N501Y |
D138Y |
N. A. |
Delta |
B.1.617.2 |
L452R, T478K |
T95I, G142D,
|
N. A. |
Omicron |
B.1.1.529 |
K417N, N440K, G446S,
|
A67V, Δ69-70,
|
R203K, G204R |
Epsilon |
B.1.427 |
L452R |
|
N. A. |
Epsilon |
B.1.429 |
L452R |
W152C |
N. A. |
Eta |
B.1.525 |
E484K |
A67V, 69del,
|
N. A. |
Iota |
B.1.526 |
E484K |
T95I |
N. A. |
Kappa |
B.1.617.1 |
L452R, E484Q |
G142D, E154K |
N. A. |
Kappa |
B.1.617.3 |
L452R, E484Q |
G142D |
N. A. |
Lambda |
C.37 |
L452Q, F490S |
G75V, T76I |
N. A. |
“Sanger sequencing is the gold standard used to validate all nucleic acid-based diagnostics,” said Dr. Lee. “Further, the Food and Drug Administration advises that false results of SARS-CoV-2 PCR tests can be investigated using Sanger sequencing.”
Individuals who wish to know the variant of SARS-CoV-2, if present, in their nasopharyngeal samples may find more information at http://www.dnalymetest.com/.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220103005028/en/
Contacts
Media:
For Milford Medical Diagnostics Laboratory, Milford, Conn.
Kevin Moore, 203-788-8497
