New decision limits and quality-control material for detecting human chorionic gonadotropin misuse in sports.
Male athletes may administer human chorionic gonadotropin (hCG) to enhance performance. Despite imposing a ban on hCG doping, the International Olympic Committee has no recommended procedure to confirm the presence of hCG. Our aim was to establish a limit for hCG in urine above which a sample may be considered positive. We measured hCG concentrations in urine samples from 1400 men with the Serono MAIAclone IRMA. Statistical evaluation of the results gave a "far outside" value [75th percentile + (3 x interquartile range)] of 5.0 IU/L; greater values are extremely unusual. Immunoreactive material in urine samples from a reference group of 120 noncompeting individuals was concentrated about sevenfold by centrifugal ultrafiltration; all these concentrated samples gave assay values < 5.0 IU/L. To ensure with the greatest possible degree of certainty that no false-positive result is reported, we propose a decision limit of 10 IU/L in nonconcentrated ultrafiltered samples. We also prepared quality-control material to contain hCG at 10 IU/L. This material provides a decision limit above which, after confirmatory procedures, a sample should be considered positive. This should help establish comparability of results among laboratories testing for sports drugs.
Department of Pharmacy, King's College London, UK.
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Laidler
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Cowan
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Hider
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Kicman
D000293:Adolescent; D000328:Adult; D006063:Chorionic Gonadotropin / Q000652:urine*; D006801:Humans; D015592:Immunoradiometric Assay / Q000706:statistics & numerical data*; D008297:Male; D011786:Quality Control; D012016:Reference Values; D012680:Sensitivity and Specificity; D013177:Sports; D015813:Substance Abuse Detection; D014462:Ultrafiltration
D006063:Chorionic Gonadotropin