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    Commercial insulin immunoassays fail to detect commonly prescribed insulin analogues

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    URI
    http://hdl.handle.net/11287/594009
    Author
    Parfitt, Ceri
    Church, D.
    Armston, A.
    Couchman, L.
    Evans, C.
    Wark, G.
    McDonald, Timothy J.
    Date
    2015-07-11
    Journal
    Clinical biochemistry
    Type
    Journal Article
    Publisher
    Elsevier
    DOI
    10.1016/j.clinbiochem.2015.07.017
    Metadata
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    Abstract
    OBJECTIVES: Blood insulin and C-peptide are key investigations in the differential diagnosis of hypoglycaemia. Analogues of insulin have modified primary-sequences compared to native human insulin, as such may not cross react with insulin assays. This has important implications in detecting surreptitious or malicious insulin administration. The aim of this study is to assess the cross-reactivity of all insulins currently listed in the British National Formulary (BNF65, 2013) in clinical insulin assays currently used in UK clinical laboratories. DESIGN AND METHODS: Sample sets were prepared for all 15 exogenous insulin classes listed in the BNF, at concentrations of 1000pmol/L and 300pmol/L, using pooled human serum. Samples were sent blinded to 5 participating analytical laboratories to cover analysis on the 10 major clinical insulin assays used in the UK. RESULTS: The ability of insulin assays to detect exogenous insulin preparations was highly variable and ranged from 0% to >140% for a single exogenous insulin. Four assays were highly specific for the human insulin sequence and had no cross-reactivity with any synthetic analogue insulin. Two detected all insulin types (human sequence, animal and synthetic analogue), with the remaining having variable cross-reactivity. CONCLUSION: The cross-reactivity of the 15 exogenous insulin preparations is highly variable in the assays used in clinical laboratories around the UK. It is important that laboratories and clinicians are aware of the limitations of their local assays to avoid missing the important diagnosis of hypoglycaemia secondary to excessive exogenous insulin. Where necessary, samples should be referred to specialist centres for insulin analysis and ideally by a validated and fully-quantitative mass spectrometry-based method.
    Citation
    Clin Biochem. 2015 Dec;48(18):1354-7
    Publisher URL
    http://www.sciencedirect.com/science/article/pii/S0009912015002787
    Collections
    • 2015 RD&E publications
    • Exeter Clinical Laboratory International (Blood Sciences, Genetics, Cellular Pathology & Microbiology)

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