检验医学与临床2025，Vol.22Issue(9)：1236-1240,5.DOI:10.3969/j.issn.1672-9455.2025.09.016
脂联素化学发光法检测性能验证及与胶乳增强免疫比浊法的一致性比较分析
Detection performance verification of chemiluminescence assay for adiponectin and comparative analysis of consistency in latex-enhanced immunoturbidimetric assay
摘要
Abstract
Objective To verify the performance indexes of the adiponectin chemiluminescence immunoas-say(CLIA)kit,to compare its consistency with the detection results of latex particle-enhanced turbidimetric immunoassay(LETIA)and evaluate the clinical application value of this methodology.Methods The preci-sion,accuracy,biological reference interval,linear range and anti-interference performance of adiponectin CLIA kit were evaluated by referring to the relevant guidelines of the United States Clinical Laboratory Standards Institute(CLSI).The consistency of the kit was compared with the adiponectin LETIA kit,and the receiver operating characteristic(ROC)curve was drawn to judge the diagnostic value of CLIA for detecting adiponec-tin in type 2 diabetes mellitus(T2DM).Results The intra-run coefficient of variation(CV)of adiponectin low-value and high-value quality control samples by CLIA were 3.51％and 2.82％,and the inter-run CV were 1.44％and 1.89％respectively,and the total CV were 3.21％and 2.98％respectively.The bias of the tracer T1 and T2 by 3 times for repetition detection was-1.29％and-0.08％respectively.The linearity of adi-ponectin concentrations detected by CLIA was good in the range of 0.16-38.25 μg/mL(r=0.998 6).Hemo-globin,free bilirubin,conjugated bilirubin and lipid emulsion were used as interference substances for interfer-ence evaluation,and the interference rate of adiponectin detected by CLIA was 10％.The Passing-Bablok re-gression equation of CLIA and LETIA was Y=0.167+0.986X(P＞0.05).The results of Bland-Altman a-nalysis showed that the bias of the two detection systems was-0.08(P＞0.05).The test results were grouped by the clinical reference value as the judgment standard,and the total coincidence rate was 94.62％,and the Kappa=0.867(P＜0.001).The ROC curve analysis results showed that the area under the curve(AUC)of CLIA in detecting adiponectin for diagnosing T2DM was 0.654,and the best cut-off value was 4.425 μg/mL.The positive and negative predictive values were 49.32％and 80.70％,respectively.Conclusion The adi-ponectin CLIA reagent kit meets the performance verification standards and requirements of manufacturer statements,and has good consistency with adiponectin LETIA reagents,which could be used as the diagnosing indicator of T2DM and has clinical promotion value.关键词
脂联素/化学发光法/胶乳增强免疫比浊法/性能评估/方法学对比/2型糖尿病Key words
adiponectin/chemiluminescence immunoassay/latex particle-enhanced turbidimetric im-munoassay/performance evaluation/methodological comparison/type 2 diabetes mellitus分类
医药卫生引用本文复制引用
彭嘉琪,王金全,彭欢子,许莹芊,何坤,谢小兵..脂联素化学发光法检测性能验证及与胶乳增强免疫比浊法的一致性比较分析[J].检验医学与临床,2025,22(9):1236-1240,5.基金项目
病毒学国家重点实验室开放研究基金资助项目(2024KF001) （2024KF001）
广东省钟南山医学基金会资助项目(ZNSXS-20240045) （ZNSXS-20240045）
湖南中医药大学学科建设"揭榜挂帅"项目(22JBZ037) （22JBZ037）
湖南中医药大学研究生创新课题项目(2024CX123) （2024CX123）
湖南省长沙市科技局软科学项目(kh2302016). （kh2302016）
