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Ursula Meier, Claudia Schnabel, Dagmar Kunz, Reinhard Driesch, Axel M. Gressner
Comparison of three commercial assays for the measurement of 17?-hydroxyprogesterone (17?-OHPR): limitations of the quality control system
The measurement of 17?-hydroxyprogesterone (17?-OHPR) is of value for the diagnosis and management of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. In the central laboratory from 2000 to 2002, we observed, using the assay from the manufacturer DSL, an elevation of the moving average of 17?-OHPR concentrations and a number of adrenocorticotropic hormone (ACTH) stimulation tests despite the lack of any changes to the internal and external quality control, of which the criteria were continuously fulfilled. We studied a population of n=49 patients for the measurement of 17?-OHPR, with and without extraction, to evaluate the quality of different commercially available radioimmunoassays. The internal and external quality controls were successful in determining 17?-OHPR. An excellent measurement and correlation of 17?-OHPR was expressed with the assay from the manufacturer IBL without extraction and from the manufacturer DSL with extraction. The quantitative determination of 17?-OHPR requires adequate specificity and accuracy of the 17?-OHPR radioimmunoassays. The results show that internal and external quality control systems are not sufficient to resolve analytical problems described in this study.
Clinical Chemical Laboratory Medicine, Walter de Gruyter
Print ISSN: 1434-6621
Volume: 42, 04/2004
Pages: 450 - 454