摘要
目的了解酶联免疫吸附试验（ELISA）试剂检测乙型肝炎表面抗原（HBsAg）假阳性的情况。方法收集2015年4—9月来自全国16家采供血单位双试剂ELISA筛查HBsAg不合格标本888例,采用罗氏和雅培双试剂化学发光进行检测,2种化学发光试剂均为反应性判为阳性,均为非反应性判为阴性,两者结果不统一时采用中和试验进行确认;多家采供血单位采用多种ELISA试剂对这批标本进行检测,本研究对其中6家实验室,每1种试剂对应3家实验室,3种试剂（试剂1、2、3）的数据进行分析。结果 888例ELISA筛查HBsAg不合格标本中罗氏和雅培双试剂化学发光均为非反应性的标本为301例,占33.9%;3种ELISA试剂在相应被用于检测的3家实验室之间的假阳性率均无明显差异（P〉0.05）;同一实验室同时使用2种ELISA试剂有3家,其中2家实验室使用试剂1和试剂2的假阳性率有明显差异（P〈0.05）;每种ELISA试剂在3家实验室检测同一标本,可能是1家、2家或3家同时出现假阳性,计算每1种的频率,其中3种试剂3家实验室同时出现假阳性的频率无明显差异（P〉0.05）,1家或2家实验室出现假阳性的频率有明显差异（P〈0.05）;分析3种试剂所对应实验室检测结果同时为假阳性时的S/Co分布,其中位数及内四分位间距存在差异。结论不同ELISA试剂检测HBsAg不合格标本的假阳性率存在差异,其假阳性检测结果的S/Co值分布不同,此数据可为献血者归队策略提供参考。
Objective To evaluate the false positive rate in unqualified donors designated by the positive HBsAg ELISA screen test. Methods A total of 888 unqualified samples were acquired from 16 blood centers nation-wide,which were then processed by both Roche ECLIA and Abbott CLIA. The samples were defined as positive only when a dual-reactive result was confirmed while a dual-nonreactive result was considered negative. Neutralization tests by several blood centers with different ELISA test kits were performed for the samples presenting inconsistent results in the two tests mentioned prior. In our study,test results were compared among 6 laboratories and 3 types of reagents（ Type 1,2 and 3）. Reagent-dependent consistency was also analyzed based on the application of each reagent in 3 different labs. Results 301 of the 888 unqualified samples were confirmed negative,accounting for 33. 9% of the total volume; No statistical significance were found in reagent-dependent consistency tests（ P 〉0. 05）; Three of the six laboratories used two types of reagents,among which,two labs＇ results showed statistical significance between type 1 and type 2 reagent.（ P〈0. 05） while the other with type 2 and 3 revealed otherwise（ P〉0. 05）; Reagent reliability tests were performed where the total chance of random false positive result by one reagent in 3 labs were calculated. No statistical significance was found comparing the chance where one reagent yields all falsepositive results in 3 labs（ P〉0. 05）. However,statistical significance was presented when the standard was lower to random false-positive results in one or two laboratories for each reagent（ P〈0. 05）; The S/Co distribution of all-false-positive results of the three reagents were analyzed and difference was identified in P50 and interquartile spacing. Conclusion The falsepositive rate is reagent-dependent in ELISA tests,which also applies to the distribution of s/co statistics of false-positive samples. This may provide valuable reference for the strategy design of blood donor re-entry.
作者
张巧琳
王露楠
谢晓艳
尹丹
魏兰
葛红卫
韩卫
潘彤
方建华
释艳华
魏超
李维
ZHANG Qiaolin;WANG Lu- nan;XIE Xiaoyan;YIN Dan;WEI Lan;GE Hongwei;HAN Wei;PAN Tong;FANG Jianhua;SHI Yanhua;WEI Chao;LI Wei(Chong Qing blood center, Chong Qing, 400000;National Center For Clinical Laboratories;Beijing Red Cross Blood Center;HeBei Blood Center;TianJin Blood Center;HeNan Red Cross Blood Center;XiangYang Center Blood Bank;CangZhou Center Blood Bank.)
出处
《中国输血杂志》
CAS
2018年第2期110-113,共4页
Chinese Journal of Blood Transfusion
