Multicenter evaluation of a rapid electrochemiluminescent adrenocorticotropic hormone (ACTH) immunoassay.
BACKGROUND
Measuring plasma adrenocorticotropic hormone (ACTH) is a key step in the differential diagnosis of hypothalamic-pituitary-adrenal disorders.


METHODS
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.


RESULTS
The within-run and between-run imprecision was <or=1.9% and <or=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.


CONCLUSIONS
The non-isotopic Elecsys ACTH immunoassay provides precision and reliability in combination with reduced turnaround time.
Verschraegen
Inge
I
Laboratory of Radioimmunology, Dutch-speaking Free University of Brussels (AZ-VUB), Laarbeeklaan 101, B-1090 Brussels, Belgium.
Anckaert
Ellen
E
Schiettecatte
Johan
J
Mees
Marleen
M
Garrido
Adolfo
A
Hermsen
Derik
D
Lentjes
Eef G W M
EG
Liebert
Andreas
A
Roth
Heinz-Jürgen
HJ
Stamminger
Gudrun
G
Smitz
Johan
J
D000307:Adrenal Gland Diseases / Q000097:blood / Q000175:diagnosis*; D000324:Adrenocorticotropic Hormone / Q000032:analysis*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D008163:Luminescent Measurements / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D010900:Pituitary Diseases / Q000097:blood / Q000175:diagnosis*; D010913:Pituitary-Adrenal System / Q000378:metabolism / Q000473:pathology; D012016:Reference Values; D012680:Sensitivity and Specificity
D000324:Adrenocorticotropic Hormone