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Molecular Diagnostics Lab in Milford, Connecticut Announces SARS CoV-2 Detection Test Including Variants

S_gene_screen_with_E484K_mutation_for_5-5-21_Release
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)


Warm congratulations to Dr. Sin Han Lee:

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

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

Comments

greyone

from Dr Burrascano presentation to Wisconsin Naturopathic Doctors Association,
talks about Igenex Lab Covid testing, including antibody option.
https://youtu.be/kO6EmeSbmMA
IGENEX 2021 PRESENTATION WISCONSIN NATUROPATHIC DOCTORS ASSOCIATION (WNDA)
the Covid part starts about 11:25 (the earlier part is about tick borne disease testing)

this is Igenex page
https://igenex.com/igenex-covid-19-testing/

Emmaphiladelphia

Dr. Fauci's main influence:
"Because of this research, I (Fauci) applied for the National Institute of Allergy and Infectious Diseases. It so happened that Dr. Schlesinger knew Dr. Sheldon Wolff at the NIH, and I came down to the NIH for an interview. I was interviewed by Dr. Wolff, and I immediately fell in love with the man. He was just my kind of person--intellectually and personally. I was accepted by Dr. Wolff right off. At the end of my residency, I came down to the NIH to work in the National Institute of Allergy and Infectious Diseases with Dr. Wolff. Over the years, even after he left the NIH, he emerged as the major mentor--personal and scientific--in my life. There have been a number of other individuals, whom I have come into contact with, who have had a major influence on me, but I think that Dr. Wolff clearly stands out as the person who made the greatest impact on my career. " https://history.nih.gov/display/history/Fauci%2C+Anthony+S.+1989

According to his SFgate obituary, Dr. Wolff "was widely honored for his discovery that the body's genetic machinery possessed natural mechanisms for repairing cell damage caused by exposure to extremely low levels of radiation. Those "repaired" cells, he found, then showed less damage after exposure to higher levels of radiation, and also to chemicals that ordinarily cause genetic mutations."

"He joined the biology division of the Oak Ridge National Laboratory in Tennessee after earning his doctorate from Harvard in 1953, and began his studies of radiation-induced cell damage there."

"Dr. Wolff served from 1996 to 2000 as vice chairman and chief of research at the Radiation Effects Research Foundation in Hiroshima, Japan."
https://www.sfgate.com/bayarea/article/Dr-Sheldon-Wolff-dies-UCSF-scientist-3281770.php

Oak Ridge hosted part of the Manhattan Project.

Emmaphiladelphia

How did U.S. taxpayers benefit from this collaboration?
https://www.utmb.edu/gnl/news/2020/04/16/the-galveston-national-lab-and-wuhan-institute-of-virology

Emmaphiladelphia

"The Wuhan Institute of Virology scrubbed the U.S. National Institutes of Health as one of its research partners from its website in early 2021. The revelation comes despite Dr. Anthony Fauci insisting no relationship existed between the institutions."
https://thenationalpulse.com/exclusive/wuhan-lab-erases-nih-ties-gof-research/?utm_source=wnd&utm_medium=wnd&utm_campaign=syndicated

"Recipients of grants from Dr. Anthony Fauci’s National Institute of Allergy and Infectious Diseases headlined a Wuhan Institute of Virology conference focusing on “gain of function research and gene editing,” The National Pulse can exclusively reveal. "
https://thenationalpulse.com/exclusive/fauci-researchers-headlined-wuhan-gain-of-function-event/

Emmaphiladelphia

"Four staff members visited the ... Jean Mérieux-Inserm Laboratory in Lyon, France; 2 visited Galveston National Laboratory, The University of Texas Medical Branch at Galveston, Texas, USA; and 1 visited the Australian Animal Health Laboratory, Geelong, Victoria, Australia for training and certification on .... laboratory operations, maintenance, and scientific or support work. These members are now the main instructors for our .... laboratory user training program."

"Articles from Emerging Infectious Diseases are provided here courtesy of Centers for Disease Control and Prevention"
https://europepmc.org/article/PMC/6478205#similar-articles

False Scientists

Yes Angus, it’s unbelievable but true. Covid vaccine for children, though they are not at risk; any justification will be used.
Who’d have thought the old vaccines could be topped for lack of testing?? You couldn’t make this up. No animal testing, phase 3 trials not complete, all for a less than 1% mortality rate. For a disease that DOES have effective therapeutics. They just want to push the va$$ines while they have ‘emergency authorization’ using the false PCR tests. Just sickening.

greyone

no blood or saliva test, Dr Lee?

angus files

Makes me wonder why they need testing when everyone is now a $ projection phor Pharma.

Canada’s health regulator has authorized Pfizer’s COVID-19 vaccine for ages 12 and older

https://www.independent.co.uk/news/canada-authorizes-pfizer-vaccine-for-age-12-and-older-health-canada-canada-pfizer-toronto-kids-b1842553.html

Pharma For Prison

MMR RIP

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