Human growth hormone (hGH) Testing – World Anti-Doping …

The concepts and development of both hGH tests have been systematically reviewed by international independent experts in such fields as hGH and IGF-I, endocrinology, immunoassay, analytical chemistry, pharmacology, laboratory work, anti-doping, etc., and published in international scientific journals.

The 2013 Court of Arbitration for Sport (CAS) decision on the FIS vs. Veerpalu case confirmed that the current Isoforms Test is robust and scientifically reliable. As a result of criticism expressed by the CAS Panel on the statistical procedure originally applied to the determination of the tests DLs, new statistical analyses were performed on an increased number of hGH doping control data (samples from athletes treated under real doping control conditions of sample collection, transportation, storage and analysis, including standardized analytical protocols and instrumentation) by two independent teams of statisticians. The results of the study have been published in an independent peer-reviewed scientific journal specialized in GH and IGF-I research.

The revised DLs have been incorporated into a new version of the Guidelines on hGH Isoform Differential Immunoassays for anti-doping analyses, available on WADAs website.These Guidelines continue to provide direction on the sample pre-analytical preparation procedure, the performance of the test and the interpretation and reporting of the test results.

For more information on the process followed to determine the tests DLs, please consult Hanley JA et al. hGH isoforms differential immunoassays applied to blood samples from athletes: decision limits for anti-doping testing. Growth Hormone & IGF Research, 2014.

The scientific validity and efficacy of the hGH biomarkers approach has been documented in multiple scientific publications for over a decade. A series of placebo-controlled recombinant recGH administration studies performed in Europe and Australia has shown that both IGF-I and P-III-NP rise substantially following recGH administration in a dose-dependent manner. These markers have been evaluated for several confounding factors that might influence the scores of the discriminant functions, including age, gender, ethnicity, exercise, diurnal and day-to-day variation, intra-individual variation, bony and soft tissue injury, sporting discipline, and body habitus (physique). Nevertheless, before resuming its implementation in WADA-accredited laboratories, the study on the determination of the DLs for the new assays will be also subjected to independent peer review and publication in an international scientific journal.

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Human growth hormone (hGH) Testing - World Anti-Doping ...