Trace Elements Clinical Laboratory
Trace Elements Clinical Laboratory is the world’s leading provider of hair tissue mineral analysis (HTMA) for thousands of health-care professionals of all specialties in over 46 countries. Its state-of-the-art testing is highly effective in helping to determine protocols to treat various degenerative conditions. HTMA also represents the best method to test for ongoing exposure to toxic heavy metals.
The accurate measurement of specific balances of intracellular minerals in the body predicts specific metabolic conditions related to many disease states. This is because specific vitamins and minerals work together as co-enzyme factors that control the action of most enzymes in the body, which in turn affect genetic expression, metabolic activity, and health dependant on enzyme function.
Over 30 years ago Trace Element’s founder Dr. David L. Watts, Ph.D. recognized the critically important links between mineral balance, vitamin utilization, enzyme activity in the body, and health. He further realized that the mineral balance in tissues, including hair, is reflective of the overall mineral balance in the body. To determine the specific affects of minerals on metabolism and disease, Watts worked with physicians to collect thousands of hair samples from patients with a wide range of confirmed medical diagnoses. As expected, most patients with specific conditions had remarkably similar balances of minerals in their tissues. This allowed his research team to determine and isolate metabolic activity, hormone function, emotional behaviour, learning capability, detoxification capability, and the existence or potential for disease states associated with specific balances of minerals & vitamins in the body.
Dr. Watts’ clinical research work on over 900,000 samples collected from MDs’ patients shows that returning cellular metabolism to normal requires the correction of mineral imbalances and elimination of toxins. The research work of Paragon’s Director Of Research Sam Bock also indicates that specific imbalance of foods and environmental factors are contributing to disease and toxicity in the body. Paragon has established an active research dialogue with Trace Elements, and works closely with Dr. Watts on specific medical case studies.
Dr. Watts’ clinical work represents a significant contribution to medicine. The following innovations and contributions made by him and his Trace Elements research team are the result of a consistent dedication to the growing field of nutritional therapeutics:
- Recognition of 1) the biochemical interrelationships between: vitamin/mineral, mineral/mineral, and vitamin/vitamin, and 2) of the importance of addressing these when formulating any nutritional plan or intervention.
- Establishment of the link between the nutritional, neurological, and endocrine systems, as determined by hair mineral patterns.
- Identification of endocrine interrelationships and their impact upon biochemical and nutritional status; recognition of specific nutritional influences upon the biochemical and endocrine systems.
- Development of a precise nutritional therapeutic approach based on the recognition of eight (8) individual biochemical types using elemental analysis of hair.
- Recognition of the Sympathetic and Parasympathetic responses to metabolic dysfunctions.
- Categorization of individual nutrients according to their sympathetic or parasympathetic effects.
- Development of metabolic supplements synergistically formulated for specific metabolic types.
Background for Patients and Physicians:
Trace Elements is a licensed and certified clinical laboratory that undergoes regular inspections with the Clinical Laboratory Division of the Department of Health and Human Services, HCFA. TEI uses ICP-Mass Spectrometry, the most modern and expensive analytical technique yet to be applied to routine elemental analysis. TEI performs all testing in a clean room environment and utilizes the latest microwave temperature-controlled digestion technique. Each patient result is based upon an hourly National Institute of Standards and Technology (NIST) traceable standard curve, a rigorous quality control validation for every 24 specimens, and is compared to a representative reference range derived from the like analysis of an international collection of normal and "healthy" subjects. TEI performs routine spiked sample recoveries, daily split specimen analysis, and voluntarily participates in various interlaboratory test comparison (TC) surveys. TEI, like many laboratories, participates in an on-going Quality Assurance/Quality Control program and adheres to CLIA guidelines for precision, reliability and overall good laboratory practices.
Trace Elements uses state-of-the-art ICP-Mass Spectrometry (Sciex Elan 6100 and 9000 models) for all trace element determinations. These multiple systems are capable of easily handling a high volume of specimens in applications such as HTMA where limits of detection requirements are in the part-per-million (ppm) and low part-per-billion (ppb) range. TEI uses the most advanced high-volume and uniform temperature-controlled microwave digestion (CEM Mars 5 Plus) technique. Microwave digestion is the method of choice for speed, reduced contamination, complete digestions, and retention of analytes to insure precise results. Trace Elements laboratory is equipped with a trace element class clean room utilizing HEPA filtration systems. The clean room ensures air quality and temperatures are isolated in order to protect equipment and processed specimens from potential contamination. High sensitivity balances used by the laboratory for calibration/QC check standards and specimen weighing are calibrated with weight sets traceable to NIST. All stock standards used for daily calibration and Quality Control are prepared by a leading ISO 9001 certified laboratory. In addition, all standard material is sourced from NIST standard reference material. The laboratory uses 18 megohm double-deionized water, sterile polypropylene wet-digestion and sampling test tubes, acid-leached, triple-rinsed miscellaneous glassware and plasticware. All glassware when used is Class A.
Trace Elements conducts daily, weekly and monthly QA/QC studies to confirm and validate all aspects of test methodology, including precision, accuracy and verifiable detection limits. The laboratory continuously evaluates different aspects of daily laboratory performance, such as; reagents, QC reference materials, split specimen analysis, double-blind samples, spiked samples, calibration-verification studies and routine daily monitoring of patient data trends, before, during and after each daily analytical run. This attention to detail assures that clients receive data obtained by the highest standards. Additional audits involve personnel training, laboratory reporting, safety issues, customer service, etc...
Laboratory management also utilizes an extremely comprehensive and thorough state-of-the art proprietary data management program that features automated quality control (AQC) software to assist the chief technologist and laboratory director in validating all QC test results and individual specimen test results prior to release for eventual report processing. Trace Elements successfully participates in an on-going proficiency testing program with Le Centre de Toxicologie du Quebec, which offers urine, blood and hair tissue elemental testing involving clinical laboratories that utilize high resolution instrumentation in North America and Europe. Also participating in various other interlaboratory test comparison studies, Trace Elements is committed to providing the clinician with timely, precise and reliable test data.