Most commercial insulin assays fail to detect recombinant insulin analogues

Ann Clin Biochem 2006;43:306-308
doi:10.1258/000456306777695690
© 2006 Association for Clinical Biochemistry

 

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Original Articles


A H Heald,
B Bhattacharya,
H Cooper,
A Ullah,
A McCulloch,
S Smellie and
G Wark


Department of Diabetes and Endocrinology, University of Manchester, Salford Royal Hospitals University Trust, Hope Hospital, Stott Lane, Salford, Greater Manchester M6 8HD, UK; Department of Medicine, Bishop Auckland General Hospital, Bishop Auckland Co., Durham DL14 6AD, UK;
Department of Medicine, Bishop Auckland General Hospital, Bishop Auckland Co., Durham DL14 6AD, UK;
Department of Medicine, Bishop Auckland General Hospital, Bishop Auckland Co., Durham DL14 6AD, UK;
Department of Medicine, Bishop Auckland General Hospital, Bishop Auckland Co., Durham DL14 6AD, UK;
Department of Medicine, Bishop Auckland General Hospital, Bishop Auckland Co., Durham DL14 6AD, UK;
Department of Medicine, Bishop Auckland General Hospital, Bishop Auckland Co., Durham DL14 6AD, UK;
SAS Peptide Section, Clinical Laboratory, Royal Surrey County Hospital, Guildford, Surrey GU2 7XX, UK

Insulin assays are utilized in various clinical scenarios, includingthe assessment of insulin therapy compliance or of suspectedinsulin overdose. In an interpretative exercise carried outby UK National External Quality Assessment Service (NEQAS),serum sent to the participating laboratories was spiked with30 pmol/L of the short-acting insulin analogue Human Actrapid.Only two out of 24 participant laboratories had sufficient assaycross-reactivity with Actrapid to interpret the results as suggestiveof insulin administration. The development of specific insulinassays has led to deterioration in the ability to detect non-complianceor overdose with recombinant insulin treatment. Clinicians shouldbe aware of this significant limitation, which could lead tomisdiagnosis.

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