抗核抗体谱IgG检测酶联免疫吸附法试剂盒的临床试验

目的 根据《体外诊断试剂临床试验技术指导原则》要求,对由欧蒙(杭州)医学实验诊断有限公司生产的酶联免疫吸附法(ELISA)二类体外诊断试剂盒中抗核抗体谱IgG检测试剂盒进行临床验证试验,以评价该试剂盒的临床应用性能.方法 收集2017年11月至2018年3月本院83例系统性红斑狼疮、夏普综合征(MCTD)、干燥综合征、...

Clinical test of ELISA kit for detection of antinuclear antibody profile IgG

Objective According to the"Technical Guiding Principles for Clinical Tests of In Vitro Diagnostic Reagents",the anti-nuclear antibody profile in the enzyme-linked immunosorbent assay(ELISA)type II in vitro diagnostic kit produced by Omon(Hangzhou)Medical Experimental Diagnostic Co.,Ltd.The IgG detection kit is subjected to a clinical validation test to evaluate the clinical application performance of the kit.Methods 83 patients with systemic lupus erythematosus,sharp syndrome(MCTD),sjogren's syndrome,progressive systemic sclerosis,dermatomyositis/polymyositis and other effective serum samples and 32 effective homologous plasmas from November 2017 to March 2018 in our hospital were collected.There were 27 healthy people with serum and 26 plasma.The anti-nuclear antibody spectrum IgG detection kit(ELISA)to be registered by Oumeng(Hangzhou)Medical Laboratory Diagnostics Co.,Ltd.was used with enzymes produced by Suzhou Haobobo Pharmaceutical Co.,Ltd.,INOVA Diagnostics,Inc.and EUROIMMUN Medizinische Labordiagnostika AG.The immunosorbent detection system detects the ANA spectrum,and evaluates the consistency of the proposed registration kit with the other three reagents by calculating the coincidence rate and Kappa test.Results The kit to be evaluated(anti-nuclear antibody profile IgG detection kit(ELISA)and the comparison kit[comparison kit 1(anti-nuclear antibody screening kit(ELISA)/comparison kit 2(anti-ribosomal P protein antibody detection)].The kit(ELISA)detects inconsistent samples,and the test results are based on the third-party kit(EUROIMMUN Medizinische Labordiagnostika AG anti-nuclear antibody profile IgG test kit(ELISA).The positive coincidence rate of the reagent/third-party reagent serum test was 100%,the negative coincidence rate was 100%,the total coincidence rate was 100%,and the Kappa value was 1.00.The positive coincidence rate of the serum and homologous plasma test of the kit to be evaluated was 100%.The negative coincidence rate was 97%,the total coincidence rate was 98%,and the Kappa value was 0.96.Conclusion The to-beevaluated kit has been verified by clinical trials.The to-be-evaluated kit is in good agreement with the test results of comparative and third-party reagents in serum and plasma and has application performance.