1. Performance Evaluation and Cross-Reactivity from Insulin Analogs with the ARCHITECT Insulin Assay
- Author
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Nobuhide Hayashi, Shunichi Kumagai, Seiji Kawano, Masahiko Mukai, Chinami Ohyabu, and Masako Moriyama
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Clinical Biochemistry ,Insulin Glargine ,Insulin analog ,Cross Reactions ,Hypoglycemia ,Diabetes mellitus ,Internal medicine ,medicine ,Humans ,Insulin ,Insulin lispro ,Pancreatic hormone ,Immunoassay ,Autoanalysis ,Insulin Lispro ,medicine.diagnostic_test ,Insulin glargine ,business.industry ,Biochemistry (medical) ,Reproducibility of Results ,medicine.disease ,Insulin, Long-Acting ,Endocrinology ,Luminescent Measurements ,Reagent Kits, Diagnostic ,business ,medicine.drug - Abstract
Background: Insulin measurement is used for the diagnosis of hypoglycemia and for insulin pharmacokinetic evaluations. We assessed the analytical and clinical performance of the ARCHITECT® insulin assay, a chemiluminescent immunoassay recently introduced for the ARCHITECT i2000 fully automated immunoassay analyzer (Abbott Laboratories). We also tested whether major insulin analogs cross-reacted with the immunoassay reagents. Methods: We used Clinical and Laboratory Standards Institute protocols to assess the analytical performance of the ARCHITECT insulin assay and compared its accuracy with that of the E-test TOSOH II (IRI) from TOSOH Corporation. We used 3 recombinant insulin analogs (lispro, aspart, and glargine) to evaluate the cross-reactivity of insulin analogs with the ARCHITECT immunoassay reagent. Results: The total CV for the ARCHITECT assay was Conclusions: The ARCHITECT insulin assay showed favorable basic performance, including reproducibility, dilution linearity, detection limit, and effects of interfering substances. When interpreting results, clinicians and laboratory pathologists should be aware of the cross-reactivity of the ARCHITECT and other immunoassays to specific insulin analogs prescribed to diabetes patients.
- Published
- 2006
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