Omicron, Delta or Other Covid Variants Can Be Diagnosed for Any Patient by Sanger Sequencing, Milford Molecular Diagnostics Dr. Sin Hang Lee Announced

MILFORD, Conn.–()–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

Variant

Pango lineage

ACE2 RBD mutations

NTD mutations

N-gene

mutations

Alpha

B.1.1.7

N501Y

69del, 70del,

144del

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,

E156del,

F157del, R158G

N. A.

Omicron

B.1.1.529

K417N, N440K, G446S,

S477N, T478K, E484A,

Q493K, G496S, Q498R,

N501Y, Y505H

A67V, Δ69-70,

T95I, G142D,

Δ143-145

R203K, G204R

Epsilon

B.1.427

L452R

 

N. A.

Epsilon

B.1.429

L452R

W152C

N. A.

Eta

B.1.525

E484K

A67V, 69del,

70del, 144del

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/.

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