HBsAg快速全血凝集诊断试剂盒的应用效果评价  

Application Effects of Rapid Wholeblood lmmunoassay Kit For Detection of HBsAg

作　　者：牛建章 逯好英[1,2] 陈淑芬 孟文华[1,2] 于秋丽 徐东刚 康铁军[1,2] 孟宗达 崔泽 朱会宾[1,2] 

机构地区：[1]河北省卫生防疫站 [2]北京军事医学科学院基础医学研究所

出　　处：《中国公共卫生》1998年第7期388-389,共2页Chinese Journal of Public Health

基　　金：河北省科委和河北省卫生厅联合资助

摘　　要：用改进的化学交联技术将抗人红血球血型糖蛋白Ａ单克隆抗体（ＭＣＡＢ－ＧＰＡ）与ＨＢｓＡｇ单克隆抗体重组，制备出检测ＨＢｓＡｇ的双功能抗体。研制出快速全血凝集ＨＢｓＡｇ检测试剂盒（ＪＫＤ）。鉴定结果表明，该试剂盒可检测１～２．５ｎｇ／ｍｌ水平的ＨＢｓＡｇ。ＪＫＤ与ＥＩＡ和ＰＨＡ方法配对检测，符合率分别为９８．３％和９８．７％。对不同人群中ＨＢｓＡｇ检测表明，１６例ＥＩＡＨＢｓＡｇ阳性病人，ＪＫＤ１００％阳性，７９例肝炎病人阳性率为６４．６％（５１／７９），７３名献血员未检出阳性，一般人群阳性率为３．８％（２／５２）。上述结果表明，该试剂盒不仅简便、快速。おt present,many grassroots units in China still can not test HBsAg in patients,For solving this problem,we constructed bispecific antibody for detection HBsAg using chemical recombination technique.Using this reagent,the rapid wholeblood immunoassay kits were combined(designed JKD).Using the kits,1～25ng/ml of HBsAg was tested in wholeblood of patients.Paired test was perfomed in JKD with EIA and PHA kits and the according rates was 983% and 987%,respectively.HBsAg in different population were detected.16 cases of HBsAg postive by EIA were 100%postive with JKD kits.The postive rates of HBsAg in viral hepatitis patients was 646%(51/79),no one postive detevtable in 73 blood donors,and in genaral population,positive rate of HBsAg was 38%(2/52).The results in this paper indicates that the JKD kit not only simplyer and faster but also have vety good senstivity and specificity.The kits can be used in bedside test of patient,screening of blood donors and epidemiological survey.In addition the kit especially suitable for application in the grassroots units in China.

关 键 词：乙型肝炎 表面抗原 试剂盒 快速全血凝集 

分 类 号：R512.620.4[医药卫生—内科学]