摘要
目的对郑州安图生物工程股份有限公司生产的抗sp100抗体Ig G检测试剂盒进行性能评价,为原发性胆汁性胆管炎(PBC)的辅助诊断提供可靠指标。方法参照美国临床和实验室标准协会(CLSI)的EP文件评价抗sp100抗体IgG检测试剂盒的灵敏度、精密度、线性区间、准确度、抗干扰等性能,同时与参比试剂盒进行临床比对。结果抗sp100抗体Ig G检测试剂盒的空白限(LoB)、检出限(LoD)、定量限(LoQ)分别为1.0、2.0、3.0 AU/ml,重复性的变异系数(CV)<4.00%,中间精密度的CV<6.00%,线性区间为10~200 AU/ml,准确度符合要求[回收率R在90%~110%之间];标本中的血红蛋白、三酰甘油、胆红素、生物素水平分别为3000 mg/dl、6000 mg/dl、50 mg/dl、250 ng/ml时,干扰率在±10%范围内。抗sp100抗体IgG检测试剂盒与两个参比试剂盒检测结果的总符合率分别为98.40%和99.20%,一致性均较好(Kappa=0.950、0.975,P<0.001)。结论该试剂盒性能良好,可满足临床检测抗sp100抗体IgG水平的需要。
Objective The performance of the anti-sp100 antibody IgG detection kit from Zhengzhou Autobio Diagnostics Co.,Ltd.was evaluated to provide reliable indicators for the auxiliary diagnosis of primary biliary cholangitis(PBC).Methods The sensitivity,precision,linear range,accuracy,and anti-interference performance of the anti-sp100 antibody IgG detection kit were evaluated in accordance with the EP document of the American Institute of Clinical Laboratory Standards(CLSI),and clinical comparison was conducted with the reference kit.Results The limit of blank(LoB),limit of detection(LoD)and limit of quantitation(LoQ)of anti-sp100 antibody IgG detection kit were 1.0,2.0 and 3.0 AU/ml,respectively.The coefficient of variation(CV)of repeatability was less than 4.00%,the CV of intermediate precision was less than 6.00%,and the linear range was 10-200 AU/ml.The accuracy met the requirements[Recovery rate R was between 90%and 110%];When the levels of hemoglobin,triacylglycerol,bilirubin,and biotin in the sample were 3000 mg/dl,6000 mg/dl,50 mg/dl,and 250 ng/ml,respectively,the interference rate was between-10%and 10%.The total coincidence rates between the anti-sp100 antibody IgG detection kit and the two reference kits were 98.40%and 99.20%,respectively,with good consistency(Kappa=0.950,0.975,P<0.001).Conclusion With good performance,the kit can meet the needs of clinical testing for anti-sp100 antibody IgG levels.
作者
尚晓楠
尤瑞国
李忠信
谢茜
Shang Xiaonan;You Ruiguo;Li Zhongxin;Xie Qian(Autobio Diagnostics Co.,Ltd.,Zhengzhou Henan 450016,China)
出处
《医疗装备》
2023年第12期13-17,共5页
Medical Equipment
关键词
磁微粒
抗sp100抗体IgG
化学发光
性能评估
Magnetic microparticle
Anti-sp100 antibody IgG
Chemiluminescence
Performance evaluation
