Our laboratory facilities are based in the United States and owned by Trace Elements Incorporated (TEI).
TEI 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. Our laboratory uses ICP-MS (Mass Spectrometry), the most modern and advanced analytical technology to be applied to routine elemental mineral analysis. Many laboratories are still using older technologies such as ICP-OES (Optical Emissions Spectrometry) and AA (Atomic Spectrometry). All testing at TEI is performed in a laboratory clean room environment, utilizing the latest microwave temperature-controlled digestion technique and using a highly skilled and professional analytical/support staff.
Further, 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. The laboratory also performs routine spiked sample recoveries, daily split specimen analysis and voluntarily participates in various interlaboratory test comparison (TC) surveys. Additionally, TEI like many leading laboratories, participates in an on-going Quality Assurance/Quality Control program and adheres to CLIA guidelines for precision, reliability and overall good laboratory practices. Needless to say, you can be assured that we stand behind our analytical data.
State of the Art Equipment and Facilities
Our HTMA facilities use state-of-the-art ICP-Mass Spectrometry methodology for all trace element determinations. These systems are capable of 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. The laboratory also uses the most advanced, high-volume and uniform temperature-controlled microwave digestion technique. Microwave digestion is the method of choice for speed, reduced contamination, complete digestions, and retention of analytes to insure precise results.
Our laboratory is equipped with a trace element class clean room utilizing HEPA filtration systems. The clean room ensures that 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. Further, the laboratory uses 16 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.
The laboratory conducts daily, weekly and monthly QA/QC studies to confirm and validate all aspects of test methodology, including precision, accuracy and verifiable detection limits. Further, the laboratory is continuously evaluating the 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 our clients are receiving data obtained by the highest standards. Additional audits involve personnel training, laboratory reporting, safety issues, customer service, etc...
Laboratory management has also recently developed an extremely comprehensive and thorough state-of-the art data management program utilizing 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 Inc 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 inter-laboratory test comparison studies, our facilities are committed to providing the clinician with the most timely, precise and reliable test data available.