[Interference of Exogenous Insulin on Insulin Detection Test by Electrochemiluminescence Immunoassay].

ABSTRACT

OBJECTIVE: To explore the interference of exogenous insulin therapy on insulin detection test by electrochemical luminescence immunoassay (ECLIA). METHODS: Insulin level was determined by ECLIA. According to the requirements of EP7-A2 of American Society for Clinical Laboratory Standards Institute Standards, paired difference experiment was conducted to evaluate the interference of 8 kinds of exogenous insulin on insulin detection, dose effect experiment was conducted to determine the relationship between exogenous insulin concentration and interference degree. RESULTS: When the interfering substance concentrations were ≤250 µU/mL, Gansulin NⓇ, Gansulin RⓇ, Humulin RⓇ,Novolin RⓇ and LantusⓇ all showed linear positive interference, while LevemirⓇ showed a linear negative interference in high concentrations insulin and non-interfering in low concentrations insulin, HumalogⓇ and Novo RapidⓇ showed non-interference in insulin detection. CONCLUSIONS: The use of different exogenous insulin may have different interference on insulin measurement, which need laboratorians and physicians notice to avoid misdiagnosis.