"Limit of Detection"
Mort Zuckerman
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Subject: "Limit of Detection"
Date: Mar 12, 2009 8:06 PM
The labs who came to the Dearborn conference
were thinking they were there to STANDARDIZE
THE METHOD of Western Blotting, not, as it
turns out, to determine what would be considered
a positive blot. That's the crime.
Many pages of the Dearborn blooklet can
be seen here:
http://www.lymecryme.com/rich_text_18.html
=====================================
FDA Rules on the VALIDATION of an Analytical Method
http://www.fda.gov/CDER/GUIDANCE/4252fnl.htm
Specificity (only detects one thing)
Accuracy (data - the detection signal or detection response - from
several samples from known concentrations is not all over the place;
with Lyme, we take the % of known positive cases that are detected to
be "Accuracy;" ie., 17/18 Bb specific band 41 or flagellin-SPECIFIC
antibody, such as the Yale Bb-Specific Flagellin antibody test; each
antibody band is as ACCURATE for diagnosis as its assigned percent
specificity)
Limit of Detection (the opposite of Steere's view of "sensitivity" -
one is supposed to show what is the LOWEST concentration of the
SPECIFIC analyte in question that the test reliably detects.)
Look at what Steere did:
http://www.relapsingfever.org
He did the opposite by fraudulently cross-indexing
LOD with Specificity.
Precision (system has integrity in performance)
Ruggedness (anyone can run the test with their own equipment and get
the same results)
Linearity (concentration range of analyte for which the test is valid)
in and out of matrix
==================================================
I guess people are not understanding this: Each antibody band is as
accurate for diagnosis as its assigned percent specificity. The Yale
flagellin method is 100% or nearly 100% SPECIFIC, and as most people
with Lyme have this band 41, 17/18 % of the cases is as Accurate as we
will ever get in an antibody test for Lyme.
Now read the Yale Flagellin Method report
and patent:
http://iai.asm.org/cgi/reprint/59/10/3531?view=long&pmid=1894359
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5,618,533.PN.&OS=PN/5,618,533&RS=PN/5,618,533
You can see that the actual "claim" of the patent
is the validation of the method:
"Because the B. burgdorferi flagellar antigen is detectable early in
infection, it could potentially prove useful in a diagnostic test.
However, the flagellar protein is known to contain epitopes which are
conserved among other spirochetes [J. L. Coleman and J. L. Benach,
"Identification And Characterization Of An Endoflagellar Antigen Of
Borrelia burgdorferi", J. Clin. Invest., 84, pp. 322-330 (1989)], and
the flagellin cross-reacts with antibodies directed against other
bacterial flagellins [L. A. Magnarelli et al., "Cross-Reactivity Of
Nonspecific Treponemal Antibody In Serologic Tests For Lyme Disease",
J. Clin. Microbiol., 28, pp. 1276-1279 (1990)]. As a result,
antibodies to this protein do not provide a specific marker for Lyme
disease.
"In view of the above, there exists an urgent need for a highly
specific and sensitive laboratory test for detection of B. burgdorferi
infection and diagnosis of Lyme disease. There also exists a need for
therapeutic agents and methods of diagnosis and treatment that are
useful in later stages of Lyme disease.
"DISCLOSURE OF THE INVENTION
"The present invention solves the problems referred to above by
providing in one preferred embodiment, flagellin polypeptides that
comprise an immunodominant region of the B. burgdorferi flagellin
antigen. The flagellin polypeptides of this invention are recognized
by sera from Lyme disease patients but have substantially no homology
to other bacterial flagellins and thus do not result in false-positive
diagnostic test results."
=================
Feel free to argue with the FDA and all of
BigPharma about how this science is done.
Yale *clearly* *knew* what they were doing.
And Steere clearly knew his Dressler/Steere
method was scientific crap and nonsense:
http://www.actionlyme.org/CRYMEDISEASE_CHP3_B.htm
Yale HAD a test. They OWN "Lyme Disease"
and they're not allowing anyone to have it.
KMDickson
"[Real] scientists are *fiercely* independent. That's the good
news."-- NIH's Top Fool, Anthony Fauci