Multicenter evaluation of a rapid electrochemiluminescent adrenocorticotropic hormone (ACTH) immunoassay

Measuring plasma adrenocorticotropic hormone (ACTH) is a key step in the differential diagnosis of hypothalamic–pituitary–adrenal disorders. The recently developed electrochemiluminescence Elecsys ACTH immunoassay (Roche Diagnostics, Mannheim, Germany) was evaluated at six clinical laboratories on t...

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Bibliographic Details
Published in:Clinica chimica acta 2007-05, Vol.380 (1), p.75-80
Main Authors: Verschraegen, Inge, Anckaert, Ellen, Schiettecatte, Johan, Mees, Marleen, Garrido, Adolfo, Hermsen, Derik, Lentjes, Eef G.W.M., Liebert, Andreas, Roth, Heinz-Jürgen, Stamminger, Gudrun, Smitz, Johan
Format: Article
Language:English
Subjects:
Adrenal Gland Diseases - blood
Adrenal Gland Diseases - diagnosis
Adrenocorticotropic hormone (ACTH)
Adrenocorticotropic Hormone - analysis
Adult
Aged
Aged, 80 and over
Female
Humans
Immunoassay
Immunoassay - instrumentation
Immunoassay - methods
Immunoassay - statistics & numerical data
Luminescent Measurements - instrumentation
Luminescent Measurements - methods
Luminescent Measurements - statistics & numerical data
Male
Middle Aged
Pituitary Diseases - blood
Pituitary Diseases - diagnosis
Pituitary-Adrenal System - metabolism
Pituitary-Adrenal System - pathology
Reference Values
Sensitivity and Specificity
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Summary:Measuring plasma adrenocorticotropic hormone (ACTH) is a key step in the differential diagnosis of hypothalamic–pituitary–adrenal disorders. The recently developed electrochemiluminescence Elecsys ACTH immunoassay (Roche Diagnostics, Mannheim, Germany) was evaluated at six clinical laboratories on the Modular E170 and/or the Elecsys 2010 (Roche Diagnostics) immunoanalysers. The within-run and between-run imprecision was ≤ 1.9% and ≤ 5%, respectively (concentration level 12–971 ng/L). Functional sensitivity was at least 1.8 ng/L. The Elecsys assay correlated well with two established ACTH immunoradiometric assays (Brahms ACTH RIA and Nichols ACTH IRMA) and with the Immulite ACTH assay. Reference values for the Elecsys ACTH assay, determined as the percentile 5 to 95 (2.5 to 97.5) interval in 354 adults without disorder with impact on the hypothalamic–pituitary–adrenal axis, were between 7.2 and 63 ng/L (5.6 and 76 ng/L). The clinical sensitivity of the Elecsys ACTH assay in 57 patients with confirmed disorders of the pituitary–adrenal axis was comparable to the established Brahms ACTH assay. The non-isotopic Elecsys ACTH immunoassay provides precision and reliability in combination with reduced turnaround time.
ISSN:0009-8981
1873-3492
DOI:10.1016/j.cca.2006.12.031