Evaluation of two immunoassays for the measurement of human chorionic gonadotropin in urine for anti-doping purposes.

Details

Serval ID
serval:BIB_29989FBD4523
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Evaluation of two immunoassays for the measurement of human chorionic gonadotropin in urine for anti-doping purposes.
Journal
Clinical Laboratory
Author(s)
Robinson Neil, Sottas Pierre-Edouard, Saugy Martial
ISSN
1433-6510[print], 1433-6510[linking]
Publication state
Published
Issued date
2010
Volume
56
Number
5-6
Pages
197-206
Language
english
Abstract
Background: Urinary human chorionic gonadotropin (hCG) concentration is routinely measured in all anti-doping laboratories to exclude the misuse of recombinant or urinary hCG preparations. In this study, extended validation of two commercial immunoassays for hCG measurements in urine was performed. Both tests were initially designed for hCG determination in human serum/plasma.
Methods: Access (R) and Elecsys (R) 1010 are two automated immunoanalysers for central laboratories. The limits of detection and quantification, as well as intra-laboratory and inter-technique correlation, precision, and accuracy, were determined. Stability studies of hCG in urine following freezing and thawing cycles (n = 3) as well as storage conditions at room temperature, 4 degrees C and 20 degrees C, were performed.
Results: Statistical evaluation of hCG concentrations in male urine samples (n = 2429) measured with the Elecsys (R) 1010 system enabled us to draw a skewed frequency histogram and establish a far outside value equal to 2.3 IU/L. This decision limit corresponds to the concentration at which a sportsman will be considered positive for hCG. Intra-assay precision for the Access (R) analyser was less than 4.0 A, whereas the inter-assay precision was closer to 4.5 % (concentrations of the official external controls contained between 5.5 and 195.0 IU/L). Intra and inter-assay precision for the Elecsys (R) 1010 analyser was slightly better. A good inter-technique correlation was obtained when measuring various urine samples (male and female). No urinary hCG loss was observed after two freeze/thaw cycles. On the other hand, time and inappropriate storage conditions, such as temperatures above 10 degrees C for more than 5 days, can deteriorate urinary hCG.
Conclusions: Both analysers showed acceptable performances and are suitable for screening urine for anti-doping analyses. Each laboratory should validate and establish its own reference values because hCG concentrations measured in urine can be different from one immunoassay to another. The time delay between urine collection and analysis should be reduced as much as possible, and urine samples should be transported in optimal conditions to avoid a loss of hCG immunoreactivity.
Keywords
Doping, hCG, Urine, MRPL, Testosterone, LH, Reference Values, Validation, Stability, Beta-Core Fragment, hCG, Misuse, Sport, Serum, Stability, Variants, Subunit, Step, Men
Pubmed
Web of science
Create date
06/07/2010 11:18
Last modification date
20/08/2019 14:09
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