The Progress in Harmonisation of Endogenous Insulin Detection
The reliable detection of endogenous insulin(hereinafter referred to as insulin)is very important for the diagnosis and evaluation of diabetes.At present,with the advantages of high throughput,high sensitivity,strong selectivity,and low cost,chemiluminescent immunoassay(CLIA)is a widely used method for insulin detection in clinic.However,the results of the external quality assurance showed that the comparability of CLIA testing was currently poor.Based on this,the main detection methods of insulin and their advantages and disadvantages were first introduced,in this study.Then,the methodological distribution of insulin detection kits on sale in China was summarized.Finally,in response to the issue of poor comparability in CLIA testing,the relevant standardization status was summarized from the aspects of standard materials and reference methods.Improvement suggestions were proposed in order to provide reference for the research and development,supervision,and metrological research of related products,and to help improve the quality of insulin testing.