电化学发光法进行HBsAg阳性确认的可行性及应用研究  

Feasibility and application of HBsAg positive confirmation by electrochemiluminescence assay in blood screening

作　　者：邓雪莲[1] 陈辉[1] 王新梅[1] 臧亮[1] 王东[1] 高慧卉[1] 邹亚轩[1] 周璐[1] 梁晓华[1] DENG Xuelian CHENG Hui WANG Xinmei ZANG Liang WANG Dong GAO Hui ZOU Yaxuan ZHOU Lu LIANG Xiaohua.(Dalian Blood Center, Dalian 116001, China.)

机构地区：[1]大连市血液中心,辽宁大连116001

出　　处：《中国输血杂志》2016年第8期806-811,共6页Chinese Journal of Blood Transfusion

基　　金：卫生部医药卫生科技发展研究中心专项课题(卫技中【2012】12号28-8-3);大连市科技计划指导性项目(大科计发【2013】50号)

摘　　要：目的评估电化学发光法HBsAg检测用于献血者HBsAg阳性确认的可行性,探索HBsAg ELISA的灰区设定条件和HBsAg阳性确认的替代方法,简化献血者归队的判定流程。方法以HBsAg电化学发光检测(Electrochemiluminescence assay,ECL)作为血液HBsAg常规筛查ELISA反应性的补充试验,并对HBsAg ECL反应性的标本进行中和试验(ECL)确证。联合核酸检测(Nucleic acid test,NAT)、ECL、ELISA检测技术以及献血者的跟踪检测进行HBsAg的阳性确认。比较电化学发光中和试验和HBsAg ECL对HBsAg ELISA双试剂反应性(S/CO≥1)中的HBV DNA阳性的检出能力;比较不同检测流程在补充HBsAg ECL检测前后以及不同灰区界值的设定对HBsAg确认阳性检出的效果影响,以敏感度(Sensitivity,SEN)和阳性预期值(Positive Predictive Value,PPV)表示;比较ELISA假反应性与确认阳性检出时S/CO值的分布差异。结果 2013年1月1日-2015年6月30日间,在本中心采集的192065份血液标本中检出HBsAg反应性821份,其中通过联合检测和献血者的跟踪检测估算出HBsAg确认阳性有160份。ECL对HBsAg ELISA双试剂反应性(S/CO≥1)标本的核酸检出显著高于电化学中和试验(P<0.05);以HBsAg ECL作为HBsAg反应性的补充试验能够将各筛查流程的HBsAg确认阳性检出的PPV提高至92.6%-99.2%(P=0);2种HBsAg ELISA试剂各自假反应性与确认阳性检出时S/CO值的分布存在着明显的差异,S/CO≤2可作为假反应性的简化判定标准;随着灰区界值的降低,2种ELISA试剂对HBsAg确认阳性检出的SEN和PPV变化均存在1个平台区,S/CO≤1时ELISA1的此2个指标即处于其平台区,ELISA2则为S/CO≤0.8。结论 HBsAg ECL能够作为血液HBsAg筛查的阳性确认试验。以该方法得到的HBsAg阳性确认数据为依据可以简化ELISA假反应性献血者归队的判定流程、合理地设定灰区。本研究采用的2种ELISA检测试剂其假反应性献血者的判定标准均可设定为S/CO≤2.0;ELISA1不宜设置灰�Objective To evaluate the feasibility of HBsAg positive confirmation by electrochemiluminescenee assay （ECL） in blood screening and to investigate the gray area setting of HBsAg ELISA and an alternative method of HBsAg posi- tive confirmation, and to simplify the algorithm of donor reentry. Method As the supplementary test, HBsAg ECL was adopted to retest samples of HBsAg reactive （ELISA） in blood screening and those HBsAg ECL reactive were confirmed by neutralization test （ECL）. HBsAg positive was eonfirmed by combination of nucleic aeid test （NAT）, ECL and ELISA and blood donor follow-up. Neutralization test （ECL） and HBsAg （ECL） were comoared for detecting HBV DNA positive among samples that were HBsAg reactive to both of two ELISA kits （S/ CO ≥ 1 ）. The detection efficiency of HBsAg positive confirmed in different detection processes supplemented with HBsAg ECL were analyzed with sensitivity （SEN） and positive predictive value （PPV）, as well as grey area setting. The S/CO value distributions of HBsAg false reactive and HBsAg positive were analyzed for each ELISA kit. Results Among 821 HBsAg reactive excluded from 192 065 samples collected in Dalian Blood Center between January 1st, 2013 and June 30th, 2015, about 160 HBsAg positive were confirmed by combination tests and blood donor follow-up. The ability of HBsAg （ECL） in detecting HBV DNA positive among samples that were HBsAg reactive to both of two ELISA kits （ S/CO ≥ 1 ） was significantly higher than that of neutralization test （ECL） （P 〈 0.05 ）. The PPV of different detection processes in detecting HBsAg positive confirmed was increased to 92. 6% -99. 2% by HBsAg （ECL） supplementary test （P = 0）. There was significant difference between S/CO value distributions of HBsAg false reactive and of the HBsAg positive confirmed for each ELISA kit. The plateau regions of SEN and PPV for two ELISA kits were observed when gray area setting was decreased. The SEN and PPV for ELISA1 were already in p

关 键 词：电化学发光 ELISA HBSAG 确认 灰区 联合检测 献血者归队 

分 类 号：R373.21[医药卫生—病原生物学] R446.11[医药卫生—基础医学]