希森美康试剂和罗氏试剂检测乙肝表面抗原的比较

摘要

目的 评估希森美康试剂定量检测乙肝表面抗原(Hepatitis B surface antigen,HBsAg)结果的重复性和罗氏试剂的相关性.方法 收集580例血清标本,用希森美康HISCL HBsAg试剂盒和罗氏Elecsys HBsAgⅡquant试剂盒进行检测,用统计学方法分析检测结果的相关性,通过与罗氏试剂检测结果比较,对希森美康试剂的特异性、敏感性和抗干扰物质能力进行评估.结果 希森美康试剂检测HBsAg的批内变异系数(coefficients of variation,CV)＜5.0％,批间CV≤5.5％.238例标本用希森美康试剂重复检测,符合率100％,其中174例HBsAg阳性标本重复检测HBsAg结果相关性r=0.999,P＜0.01.122例正常对照组两种试剂检测HBsAg均为阴性,符合率100％.287例HBsAg标本阳性希森美康与罗氏试剂检测HBsAg结果的相关性r=0.996,P＜0.01.对含有可疑干扰物的标本,两种试剂检测结果相近(孕妇和婴儿r=0.992,P=0.000;各种病毒或梅毒感染r=0.995,P=0.000;抗病毒药物r=0.994,P=0.000;HBV基因变异耐药r=0.998,P=0.000;抗核抗体及类风湿因子r=0.997,P=0.000).结论 希森美康试剂检测HBsAg结果的重复性佳,与罗氏试剂具有良好的相关性.%Objective To evaluate the repeatability of HISCL HBsAg kits and the correlation comparing with Roche kits.Methods A total of 580 serum samples were collected,HBsAg levels were detected by HISCL HBsAg kits and Elecsys HBsAg Ⅱ Quant kits,respectively.Data were analyzed,and the specificity,sensitivity and anti-jamming capability of HISCL kits were assessed by comparing with Roche kits.Results The intra-assay coefficients of variation (CV) of HISCL HBsAg kits was ＜ 5.0％,and Interassay CV was ≤5.5％.238 samples were repeated testing with HISCL HBsAg kits and the coincidence was 100％.Within them,the repeating detection results of 174 positive samples by HISCL HBsAg kits had agood correlation (r =0.999,P ＜0.01).122 cases of normal control were detected negative by both kits,and the coincidence was 100％.The correlation of HBsAg results from 287 HBsAg positive samples detected by the two kits was r =0.996,P ＜ 0.01.For the samples containing suspicious interferences,the results of the two kits were similar(pregnant women and infants r =0.992,P =0.000;antiviral drugs r =0.994,P =0.000;various virus or syphilis r =0.995,P =0.000;HBV gene mutation r =0.998,P =0.000;antinuclear antibodies and rheumatoid factor r =0.997,P =0.000).Conclusions HISCL HBsAg kits have a good repeatability and a excellent correlation with Elecsys HBsAg Ⅱ Quant kits.