抗核抗体谱IgG检测酶联免疫吸附法试剂盒的临床试验  

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

作　　者：王思英 杨湘越 WANG Siying;YANG Xiangyue(Department of Blood Transfusion,the First Affiliated Hospital of Fujian Medical University,Fuzhou,Fujian,350005,China;Department of Inspection,900th Hospital of Joint Logistics,Fuzhou,Fujian,350001,China)

机构地区：[1]福建医科大学附属第一医院输血科,福建福州350005 [2]联勤保障部队第900医院检验科,福建福州350001

出　　处：《当代医学》2021年第7期95-98,共4页Contemporary Medicine

基　　金：福建省科技计划项目(2018Y0068)。

摘　　要：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、进行性系统性硬化症、皮肌炎/多肌炎等患者有效血清样本及32例有效同源血浆,对照组为健康人群,其中血清27名、血浆26名。使用欧蒙(杭州)医学实验诊断有限公司拟注册的抗核抗体谱IgG检测试剂盒(ELISA)分别与苏州浩欧博生物医药有限公司、INOVA Diagnostics,Inc.及EUROIMMUN Medizinische Labordiagnostika AG生产的酶联免疫吸附法检测系统检测ANA谱,通过计算符合率和Kappa检验评价分析拟注册试剂盒与其他3种试剂的一致性。结果待评价试剂盒(抗核抗体谱IgG检测试剂盒(ELISA)与对比试剂盒,包括[对比试剂盒1[抗核抗体筛查试剂盒(ELISA)]/对比试剂盒2[抗核糖体P蛋白抗体检测试剂盒(ELISA)]检测不相符的样本,以第三方试剂盒EUROIMMUN Medizinische Labordiagnostika AG生产的抗核抗体谱IgG检测试剂盒(ELISA)的检测结果为准,最终待评价试剂盒与对比试剂/第三方试剂的血清检测阳性符合率为100%,阴性符合率为100%,总符合率为100%,Kappa值为1.00。待评价试剂盒检测血清与同源血浆检测阳性符合率为100%,阴性符合率为97%,总符合率为98%,Kappa值为0.96。结论待评价试剂盒经过临床试验验证,待评价试剂盒与对比试剂/第三方试剂血清及血浆检测结果符合性良好,具备应用性能。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

关 键 词：抗核抗体谱 抗核抗体谱IgG检测试剂盒 临床试验 一致性 

分 类 号：R446.6[医药卫生—诊断学]