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Assessment of ACTH assay variability: a multicenter study.

Francesca Pecori Giraldi¹, Andrea Saccani, Francesco Cavagnini

¹Chair of Endocrinology, University of Milan, Ospedale San Luca, Istituto Auxologico Italiano IRCCS, Piazzale Brescia 20, 20149 Milan, Italy.

European Journal of Endocrinology

|January 22, 2011

Summary

Plasma ACTH assay variability impacts endocrine disorder diagnosis. Routine assays show significant inconsistencies, especially for low ACTH levels, necessitating standardization for accurate patient care.

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Area of Science:

Endocrinology
Clinical Chemistry
Assay Development

Background:

Plasma adrenocorticotropic hormone (ACTH) measurement is crucial for diagnosing endocrine disorders.
Limited data exists on the variability and clinical impact of routine ACTH assay results.

Purpose of the Study:

To evaluate the performance and variability of routine plasma ACTH assays.
To assess the impact of assay variability on clinical practice.

Main Methods:

Twenty-five plasma samples with varying ACTH levels were tested across seven different assays in 35 laboratories.
Assay precision, method agreement, and patient result classification were analyzed.

Main Results:

Inter- and intra-assay variability ranged significantly, with some assays exceeding 20% coefficient of variation.
Method agreement was generally good but showed wide limits of agreement, influenced by both assay and laboratory differences.
Accurate classification was high for normal (90%) and high (95%) ACTH, but poor for low ACTH (60%).

Conclusions:

Routine ACTH assays exhibit high variability and frequently misclassify patients with suppressed ACTH.
Interpretation of ACTH assay results requires caution due to performance limitations.
Standardization of ACTH assays is recommended for the endocrine community.