Toward standardization of insulin immunoassays

W. Greg Miller, Linda M. Thienpont, Katleen Van Uytfanghe, Penelope M. Clark, Patrik Lindstedt, Göran Nilsson, Michael W Steffes

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1011-1018
Number of pages8
JournalClinical chemistry
Volume55
Issue number5
DOIs
StatePublished - May 1 2009

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Immunoassay
Standardization
Insulin
Serum
Calibration
Liquid chromatography
Medical problems
Isotopes
Dilution
Tandem Mass Spectrometry
Mass spectrometry
Liquid Chromatography
Insulin Resistance
Diabetes Mellitus

Cite this

Miller, W. G., Thienpont, L. M., Van Uytfanghe, K., Clark, P. M., Lindstedt, P., Nilsson, G., & Steffes, M. W. (2009). Toward standardization of insulin immunoassays. Clinical chemistry, 55(5), 1011-1018. https://doi.org/10.1373/clinchem.2008.118380

Toward standardization of insulin immunoassays. / Miller, W. Greg; Thienpont, Linda M.; Van Uytfanghe, Katleen; Clark, Penelope M.; Lindstedt, Patrik; Nilsson, Göran; Steffes, Michael W.

In: Clinical chemistry, Vol. 55, No. 5, 01.05.2009, p. 1011-1018.

Research output: Contribution to journalArticle

Miller, WG, Thienpont, LM, Van Uytfanghe, K, Clark, PM, Lindstedt, P, Nilsson, G & Steffes, MW 2009, 'Toward standardization of insulin immunoassays', Clinical chemistry, vol. 55, no. 5, pp. 1011-1018. https://doi.org/10.1373/clinchem.2008.118380
Miller WG, Thienpont LM, Van Uytfanghe K, Clark PM, Lindstedt P, Nilsson G et al. Toward standardization of insulin immunoassays. Clinical chemistry. 2009 May 1;55(5):1011-1018. https://doi.org/10.1373/clinchem.2008.118380
Miller, W. Greg ; Thienpont, Linda M. ; Van Uytfanghe, Katleen ; Clark, Penelope M. ; Lindstedt, Patrik ; Nilsson, Göran ; Steffes, Michael W. / Toward standardization of insulin immunoassays. In: Clinical chemistry. 2009 ; Vol. 55, No. 5. pp. 1011-1018.
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