Assessment of ACTH assay variability: a multicenter study
Abstract
Objective Measurement of plasma ACTH plays a pivotal role in the diagnosis and treatment of several endocrine disorders. Little is known, however, on the variability of ACTH assay results and its impact on clinical practice. The aim of the present study was to assess the performance of routine plasma ACTH measurements. Design Twenty-five fresh-frozen plasma samples collected from patients with either high, low, or normal ACTH concentrations were measured using seven different assays by 35 different laboratories. Assay precision, method agreement, and result classification were estimated. Results Inter- and intra-assay coefficient of variation varied considerably with some assays achieving 20%. Overall method agreement was good (mean ratio versus target value 1.02) but subject to exceedingly large excursion (lower and upper limits of agreement at 0.13 and 1.91 respectively). Both differences between assays and between laboratories contributed to variability of method agreement. Assays correctly classified most patients with normal and high ACTH concentrations (90% (95% CI 82-97%) and 95% (95% CI 86-100%) respectively), whereas only 60% (95% CI 52-67%) of measurements from patients with low ACTH values were assigned correctly. Conclusions Field ACTH assays have to be interpreted with caution as they are burdened by high variability and often fail to correctly identify patients with suppressed ACTH secretion. The endocrine community has to include ACTH assays among those requiri…
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Setting a specific cut-point for ACTH levels suggesting PAI is highly influenced by analytical bias in ACTH assays.
“The challenge with setting a specific cut-point for ACTH levels suggesting PAI is highly influenced by analytical bias demonstrated in ACTH assays (69,70).”
From Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine Society Clinical Practice Guideline (2016) · cites this paper as [70]
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“These ACTH assays, like other endocrine immunoassays, suffer from standardization differences due to absence of a commutable reference material and internationally accepted reference method [1, 13, 14].”
Current challenges in Cushing's syndrome testing: blood, saliva, urine, or hair?
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Adrenocorticotropic Hormone Immunoassay Interference in a Patient with Subclinical Hypercortisolism
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Challenges in Endocrinology Testing
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Adrenal insufficiency - causes and laboratory diagnosis
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Striae rubrae: Cushing’s syndrome
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- Authors
- Pecori Giraldi, F., Saccani, A., Cavagnini, F., & _, _.
- Affiliations
- University of Milan (IT)
- Corresponding author
- Cavagnini, Francesco
- Venue
- European Journal of Endocrinology
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-04
- Volume
- 164
- Issue
- 4
- Pages
- 505-512
- ISSN
- 0804-4643 (ISSN-L)
- 1479-683X
- OpenAlex
- W2131830610
- Cited by
- 80
- References
- 36
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 6 · 2023: 4 · 2022: 5 · 2021: 11 · 2020: 6 · 2019: 7 · 2018: 4 · 2017: 7 · 2016: 7 · 2015: 6 · 2014: 2 · 2013: 4 · 2012: 1
- FWCI
- 2.17
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Endocrinology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Reliability and Agreement in Measurement
- Keywords
- assay variability, interlaboratory agreement, assay precision, measurement agreement, ACTH suppression, assay standardization
- MeSH terms
- Adrenocorticotropic Hormone, Biological Assay, Humans, Reproducibility of Results
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