Comparison of three commercial assays for the measurement of 17α-hydroxyprogesterone (17α-OHPR): limitations of the quality control system

Verfasser / Beitragende:
[Ursula Meier, Claudia Schnabel, Dagmar Kunz, Reinhard Driesch, Axel M. Gressner]
Ort, Verlag, Jahr:
2004
Enthalten in:
Clinical Chemistry and Laboratory Medicine, 42/4(2004-04-05), 450-454
Format:
Artikel (online)
ID: 378890549
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024 7 0 |a 10.1515/CCLM.2004.078  |2 doi 
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245 0 0 |a Comparison of three commercial assays for the measurement of 17α-hydroxyprogesterone (17α-OHPR): limitations of the quality control system  |h [Elektronische Daten]  |c [Ursula Meier, Claudia Schnabel, Dagmar Kunz, Reinhard Driesch, Axel M. Gressner] 
520 3 |a 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. 
540 |a Copyright © 2004 by Walter de Gruyter GmbH & Co. KG 
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700 1 |a Driesch  |D Reinhard  |4 aut 
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