Toward standardization of insulin immunoassays
Open accessAbstract
Background: Measurement of circulating insulin may improve the classification and management of diabetes mellitus and assist in treating people with insulin resistance. Methods: A work group convened by the American Diabetes Association evaluated results for a panel of 39 single donor sera measured by 10 commercial insulin methods from 9 manufacturers against an isotope dilution–liquid chromatography/tandem mass spectrometry (IDMS) measurement procedure calibrated using purified recombinant insulin. We used a candidate primary (pure substance) reference material, pooled serum, and single donor sera to evaluate approaches to achieve improved agreement of results between the routine and reference measurement procedures. Results: Four of 10 methods had ≥95% of individual serum results within 32% of the IDMS concentrations. However, the bias vs IDMS was more than 15.5% for 7 of 10 methods in 36%–100% of individual samples. A purified recombinant insulin preparation used as a common calibrator did not improve harmonization of results among routine methods but was not used as instructed by all participants. Calibration using serum pools achieved bias <15.5% for nearly all results in the concentration range covered by the pools (>60 pmol/L). Calibration using a panel of individual sera was the most effective to improve harmonization of results over the full measuring range. Conclusions: Agreement among methods can be improved by establishing traceability to the IDMS procedure using a panel of native sera. Pooled sera may be useful as trueness control materials. The usefulness of the pure insulin primary reference material [candidate reference material for insulin (cRMI)] requires clarification of protocols used by manufacturers.
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An insulin standardization workgroup called for harmonization of insulin assay results through traceability to an isotope-dilution liquid chromatography-tandem mass spectrometry reference.
“Recently, an insulin standardization workgroup of the ADA, in conjunction with the National Institute of Diabetes and Digestive and Kidney Diseases, the CDC, and the European Association for the Study of Diabetes, called for harmonization of insulin assay results through traceability to an isotopedilution liquid chromatography-tandom mass spectrometry reference (373).”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [373]
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Brogan, R. J., Rooyackers, O., Phillips, B. E., Twelkmeyer, B., Ross, L. M., Atherton, P. J., Kraus, W. E., Timmons, J. A., & Gallagher, I. J. (2025) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgaf285 · Cited by 10 · see citing works
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“The groups are combining efforts to improve standardization with the aim of establishing a complete reference measurement system and certified primary reference materials based on pure biosynthetic insulin and C-peptide [42].”
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“Discussion Several attempts have been so far made for the global standardization of major serum proteins [23-25].”
BackgroundThe current status of serum insulin measurements and the need for standardization
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“Efforts to standardize insulin assays have yielded inconsistent results [12], prompting calls for harmonization through traceability to a reference standard which is liquid chromatography – tandem mass spectrometry [13].”
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“The electrospray ionization ID-MS procedure has been reported, but the imprecision and sensitivity were unsatisfactory [14–16].”
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“[11] Considering these limitations, the scientific community has diligently explored simpler, more precise, and practical surrogate markers of insulin resistance derived from various conventional peripheral blood biochemical indicators.”
BackgroundApplication of serum pools in insulin harmonization: Commutability and stability
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Translation: Roadmap for Harmonization of Clinical Laboratory Measurement Procedures
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Challenges in endocrinology testing
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“relatively costly and lack of standardization makes their interpretation less straightforward (Manley et al., 2007; Little et al., 2008; Miller et al., 2009; Tohidi et al., 2017).”
BackgroundInsulin-like growth factor-I in the domestic cat
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High Serum Insulin Level in Neonatal Hypoglycemia: A False Expectation
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“The other caveat is that a complete reference system in conformance with International Organization for Standardization requirements is yet to be established for insulin [3].”
- Authors
- Miller, W. G., Thienpont, L. M., Van Uytfanghe, K., Clark, P. M., Lindstedt, P., Nilsson, G., Steffes, M. W., & for the Insulin Standardization Work Group
- Affiliations
- Virginia Commonwealth University (US)
- Ghent University (BE)
- Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Gent University, Gent, Belgium
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Mercodia, Uppsala, Sweden
- Nilsson Measurement Quality, Uppsala, Sweden
- University of Minnesota (US)
- Corresponding author
- Miller, W Greg
- Venue
- Clinical Chemistry
- Publisher
- Oxford University Press (OUP)
- Published
- 2009-05-01
- Volume
- 55
- Issue
- 5
- Pages
- 1011-1018
- ISSN
- 0009-9147 (ISSN-L)
- 1530-8561
- OpenAlex
- W2041172413
- Cited by
- 111
- References
- 11
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 3 · 2023: 6 · 2022: 5 · 2021: 9 · 2020: 4 · 2019: 10 · 2018: 6 · 2017: 5 · 2016: 6 · 2015: 4 · 2014: 4 · 2013: 16 · 2012: 8
- FWCI
- 6.17
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Clinical Chemistry (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Funders
- American Diabetes Association
- GlaxoSmithKline
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- insulin immunoassay, assay standardization, reference measurement procedure, measurement agreement, measurement bias, traceability, diabetes mellitus, insulin resistance
- MeSH terms
- Diabetes Mellitus, Humans, Immunoassay, Insulin, Radioisotope Dilution Technique, Reagent Kits, Diagnostic, Spectrometry, Mass, Electrospray Ionization
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