Valid lab test for Lyme?

Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
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LymeEnigma
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Re: Valid lab test for Lyme?

Post by LymeEnigma » Fri 11 Jul 2008 21:06

Martian wrote:Isn't this "replacement" a bit vague, not to say dubious? Isn't this simply Bowen Labs with a new name?
Name changes are usually pretty decent red flags....

So which labs do all of you recommend? IGenex? With its connections to Stephen Harris? Fry (whoever the hell they are ... seemed to pop up and become the new rage overnight)? Are there labs in Europe that anyone over there feels they can trust? I honestly don't trust anyone these days ... my blood tests have been so varied, even among the same labs ... I'd love to see some information, any information, that might take away some of my disillusionment on this subject.

Pandora
Posts: 252
Joined: Tue 20 Mar 2012 14:58

Re: Valid lab test for Lyme?

Post by Pandora » Thu 21 Aug 2014 3:05

By: Colleen E. McCarthy

Washington, DC—The U.S. Food and Drug Administration (FDA) recently notified Congress that it intends to issue drafts of guidance documents on lab-developed tests.

The draft guidance is titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).”

FDA convenes to discuss updating contact lens guidance

The move comes after several senators called for the White House Office of Management and Budget to release the draft guidance for public comment. Earlier this year, the Centers for Disease Control and Prevention

+++ (CDC) released a notice that a common lab-developed test for Lyme disease commonly results in false-positives.+++

“The draft Framework Guidance proposes a risk-based, phased-in framework for oversight of LDTs in a manner that is consistent with FDA’s current regulation of in vitro diagnostic devices,” says Sally Howard, deputy commissioner for policy, planning, and legislation for the FDA, in a letter to the Senate Committee on Health, Education, Labor, and Pensions.

“The accompanying draft guidance describes the manner in which laboratories may provide notification and comply with medical device adverse event reporting,” Howard wrote.
- See more at: http://optometrytimes.modernmedicine.co ... ZGrls.dpuf
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I believe its important to bring this to light considering ISDA's NEW vaccine guidelines for the ImmunoSuppressed:
http://www.pharmacytimes.com/news/Guide ... epth-Guide

NOT taking into consideration the over 95% of the pops infected with Epstein Borreliosis:
"Our combined results show that EBV employs deubiquitination of signaling intermediates in the TLR cascade as a mechanism to counteract innate anti-viral immunity of infected hosts."
http://www.ncbi.nlm.nih.gov/pubmed/24586164

Shed antigenic Blebs/Liposomes/exosomes/ or whatever they prefer to call infectious organisms secretions these days. AND the viral fungal/prion protein recombinations that grow with proteins that behave as genes.

Regulation of Toll-like receptor 2 interaction with Ecgp96 controls Escherichia coli K1 invasion of brain endothelial cells. (PMID:22963587) http://europepmc.org/abstract/MED/22963587

THE IDSA/CDC/NIH/FDA/USDA/HHS ARE DIRECTLY RESPONSIBLE FOR AUTISM KIDS SUFFERING AND THE MILLIONS SUFFERING SYNDROMES, PSYCH, AND YES CANCERS THEY CAUSED ADDING TO THE MIX THEY ALREADY GAVE US. JUST AS SURELY AS OVER 8000 US SOLDIERS COMMITTED BRAIN INFECTED SUICIDE , OVER 7000 HAITIANS DEAD FROM INFECTIOUS VACCINES, AND NO TELLING HOW MANY AFRICAN'S WILL FALL FROM ADDING TO THE MIX AND FAILURES TO TREAT THE REAL CAUSE OF AIDS IMMUNE SUPPRESSION.

http://www.lymeneteurope.org/forum/view ... 251#p37251

http://www.accessdata.fda.gov/scripts/c ... fm?ID=3184

They Knew in 1986 and 1981 there were no false positives.
Lyme Test:search box
http://www.accessdata.fda.gov/scripts/c ... /index.cfm

There is no more Normal and yes we all have spirochetal prion protein infections.

Concerns Regarding a New Culture Method for Borrelia burgdorferi Not Approved for the Diagnosis of Lyme Disease
http://www.cdc.gov/mmwr/preview/mmwrhtm ... mm6315a4_w
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