Greenberg Oral Chelation Study-page 5
Testing Laboratory Services Discussion
Doctors Data Laboratory was selected as our preferred testing laboratory due to its established quality controls and longstanding reputation with other government agencies including The World Health Organization, the International Atomic Energy Agency, EPA, ATSDR, CDC, NIH and Justice Dept.. Blood & Hair Elemental profiles are measured with ICP-Mass Spectroscopy, and reported back with established comparative reference ranges along with actual results. Doctor's Data's reference ranges are established using the standardized protocol published by NCCLS. Reference ranges are determined using a comparative decision making process, utilizing Doctor's Data's hundreds of thousands of patient data and an American healthy population study. Doctor's Data is licensed as a clinical laboratory by CLIA, New York, Florida, and Maryland. Doctor's Data has scored consistently high on the CLIA mandated CAP, Le Centre de Toxicologie du Quebec, and New York Department of Health proficiency testing programs (PT), and performs interlaboratory comparisons with other labs that use ICP-MS such as Mayo Medical Labs. Doctor's Data has comparable results to other laboratories using ICP-MS as demonstrated by our successful participation in the comparison program for hair analysis by ICP-MS offered by Le Centre de Toxicologie du Quebec. A summary of Doctor's Data proficiency testing program results is available upon request. In addition to PT, Doctor's Data has extensive Quality Control processes that ensure precision and reliability which include calibration verification and monitoring standards; preparation blanks; laboratory controls and reference materials (low, medium, and high controls); spiked samples and duplicate analyses. Doctor's Data uses a state-of-the-art laboratory clean room specially designed for trace element analysis, which includes metal-free walls, floors, and ceilings, ultra-pure water, and HEPA filtration systems.
Doctor's Data uses a modified version of the standardized sample preparation method published by the International Atomic Energy Agency (IAEA/RL/50, Vienna). This method consists of cutting the hair into .3cm pieces and mixing to obtain a representative sample, washing the hair three times with Triton X-100 to remove external contamination, and rinsing with acetone and de-ionized water twice. The sample is then digested using trace metal free nitric acid and temperature controlled microwave digestion. This method has been demonstrated to remove external contamination yet retain volatile elements that can be cooked off using other methods such as open beaker digestion. For more information on Doctor's Data's method, see "Preparation of Hair for Measurement of Elements by Inductively Coupled-Mass Spectrometry (ICP-MS)", Biological Trace Element Research, Vol. 62, 1998
Hair analysis lab info:
To be performed by: DOCTOR'S DATA, INC
Address: 3755 Illinois Avenue, St. Charles, IL 60174-2420 www.doctorsdata.com EMAIL: firstname.lastname@example.org TEL: 800.323.2784 FAX: 630.587.7860
LABORATORY DIRECTOR: James T. Hicks, MD, Ph.D., FCAP MEDICARE PROVIDER NO: 148453, CLIA ID NO: 14D0646470 TAX ID NO. (FEIN): 93-0941625
Commonly Misinterpreted Article published in JAMA 1/3/01
:An article entitled "Assessment of Commercial Laboratories
Performing Hair Mineral Analysis" by Seidel, et al, was
published in the January 3, 2001 edition of JAMA (Vol. 285,
No. 1). The authors' primary conclusion was that hair mineral
analysis should not be utilized by health care practitioners
due to interlaboratory variability. Although the author's
conclusion is relevant only for hair analysis for "Hair
Minerals" and not for "Toxic Metals" (long
established as a valid bio-marker), there has been a mis-interpretation
by the mainstream press that ALL hair analysis is invalid.
The study reported which involved sending samples from one
patient to six different labs. Yes JAMA published a ONE patient
study! Even though this article is NOT relevant to the validity
of our Chelorex
data we thought it necessary to clarify that we have investigated this article before choosing one of the 2 labs that were statistically identical (as per the JAMA article) due to their technologically advanced standardized quality testing methods. We have provided for reference a summary of Doctors Data's initial response as published on their website and printed below.
" The study's design only supports the answer to one
specific question: "Are all hair analysis labs equal?"
The answer is a clear-cut NO. We strongly agree that there
are several laboratories that do a poor job- employing outdated
methodologies; recommending, promoting, and/or selling supplements
without ever seeing the patient; and, in one case, misrepresenting
their CLIA license status. We strongly disagree that health
care practitioners should refrain from using hair analysis
based upon the conclusions of this article. The experimental
design that was utilized (in the JAMA study) does NOT permit
scientifically valid conclusions pertaining to the use or
clinical value of hair analysis when performed by a high quality,
licensed laboratory that utilizes state of the art methodology.
Absolutely no evidence was provided to discredit the high
quality hair analyses that are performed at Doctor's Data."
For further detailed response see "Doctors Data's Response"
at: www.doctorsdata.com JAMA Article link: http ://pubs.ama-assn.org