Oral Chelation - Detox Health

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:
Address: 3755 Illinois Avenue, St. Charles, IL 60174-2420 www.doctorsdata.com EMAIL: inquiries@doctorsdata.com 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

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*These statements have not been evaluated by the Food and Drug Administration(FDA). This product is not intended to diagnose, treat, cure or prevent any disease.