Comparison of three commercial assays for the measurement of 17α-hydroxyprogesterone (17α-OHPR): limitations of the quality control system
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Ursula Meier
Abstract
The measurement of 17α-hydroxyprogesterone (17α-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 17α-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 17α-OHPR, with and without extraction, to evaluate the quality of different commercially available radioimmunoassays. The internal and external quality controls were successful in determining 17α-OHPR. An excellent measurement and correlation of 17α-OHPR was expressed with the assay from the manufacturer IBL without extraction and from the manufacturer DSL with extraction. The quantitative determination of 17α-OHPR requires adequate specificity and accuracy of the 17α-OHPR radioimmunoassays. The results show that internal and external quality control systems are not sufficient to resolve analytical problems described in this study.
Copyright © 2004 by Walter de Gruyter GmbH & Co. KG
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- How useful are haematology analyser flags?
- Intravenous immunoglobulin (IVIG): modes of action in the clinical management of recurrent pregnancy loss (RPL) and selected autoimmune disorders
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- Extracellular concentration of homocysteine in human cell lines is influenced by specific inhibitors of cyst(e)ine transport
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