Comparison of 11 human insulin assays: implications for clinical investigation and research.

Abstract:

BACKGROUND:The American Diabetes Association task force on standardization of insulin assays in 1996 showed wide variation in assay bias. Newer assays are specific for insulin, with several now available on automated immunoassay analyzers. METHODS:In 2004, we compared 11 commercially available insulin assays by analyzing 150 serum samples (99 fasting/51 postprandial) from study participants with various degrees of glucose intolerance (exclusions being type 1 diabetes, insulin treatment, or presence of insulin antibodies). All assays were calibrated against International Reference Preparation 66/304. One assay was not specific for insulin and another was an RIA; 10 assays used enzyme/chemiluminescent labels. Bland-Altman difference plots were modified to use the mean insulin from all assays on the x-axis as a common comparator. RESULTS:As in the 1996 study, insulin values from the different assays varied by a factor of 2, with the nonspecific assay ranking in the middle of the distribution. Spearman rank correlation coefficients, for ranking samples vs the mean, were 0.983-0.997. Both offsets and concentration-dependent differences were seen in the modified difference plots. Imprecision (mean CV) for automated assays (3%) was not significantly different from manual assays (5%). Similar values were obtained when one automated assay was run in laboratories in both the UK and the US. Results of 1 assay showed lower insulin concentrations in heparinized plasma than in serum. CONCLUSIONS:Assay performance must be considered before comparing insulin results. The 2-fold variation in insulin results may be related to specificity, manufacturers' calibration procedures or conversion factors.

journal_name

Clin Chem

journal_title

Clinical chemistry

authors

Manley SE,Stratton IM,Clark PM,Luzio SD

doi

10.1373/clinchem.2006.077784

subject

Has Abstract

pub_date

2007-05-01 00:00:00

pages

922-32

issue

5

eissn

0009-9147

issn

1530-8561

pii

clinchem.2006.077784

journal_volume

53

pub_type

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