抗核抗体间接免疫荧光法检测试剂的比对分析

摘要

目的 通过AESKU试剂和欧蒙试剂对164例抗核抗体核型结果的比对分析,评价AESKU试剂间接免疫荧光法抗核抗体检测试剂的性能.方法 从2015年1~12月广东省中医院门诊及住院患者中选取164例样本,分为AID患者组(n=115)和健康对照组(n=49),同时采用AESKU试剂与欧蒙试剂对抗核抗体核型进行双盲、平行检测,不一致结果采用第三方试剂复核.计算两种试剂的阳性符合率、阴性符合率、总符合率、Kappa系数,并进行Kappa一致性检验和配对χ2检验.结果 AESKU试剂与欧蒙试剂的总体阳性符合率为94.78%,阴性符合率为93.88%,总符合率为94.51%;Kappa=0.871,P<0.05,两种试剂的检测结果高度一致,差异无统计学意义(P>0.05).结论 AESKU试剂与欧蒙试剂具有等效性和很高的符合率,操作简便快速、结果清晰易读,适合临床广泛应用.%Objective To evaluate the performance of AESKU reagent antinuclear antibody detection kit (indi-rect immunofluorescence) by comparative analysis of 164 ANA results between the two kinds of AESKU kit and Euroim-mun kit. Methods From January 2015 to December 2015, the samples of 164 outpatients and inpatients in Guangdong Provincial Traditional Chinese Medical Hospital were divided into AID group (n=115) and healthy control group (n=49). The patterns of antinuclear antibodies were detected by double blind parallel testing by 2 systems with AESKU kit and Euroimmun kit. Inconsistent results were reviewed by the third reagent. The positive coincidence rate, negative coinci-dence rate, total coincidence rate and Kappa coefficient were calculated, and the Kappa consistency test and paired chi-square test were evaluated by the two kits. Results The positive coincidence rate between AESKU kit and Euroim-mun kit was 94.78%, the negative coincidence rate was 93.88%, and the total coincidence rate was 94.51%. The testing results of the two kits were highly consistent (Kappa=0.871, P<0.05). The paired chi-square test showed no statistically significant difference (P>0.05). Conclusion AESKU kit and Euroimmun kit were equivalent and highly coincident. AESKU kit was easy to operate and clear to read the result. So it's suitable for wide clinical application.