HBsAg乳胶层析检测试纸条漏检原因分析  

False Negative Detection of HBsAg Using Latex Chromatogram Test Paper

作　　者：余妙嫦[1] 冯健亮 廖世生[1] 古锦萍 廖惠容 梁家群[1] 

机构地区：[1]广东省江门市中心血站,江门529000

出　　处：《热带医学杂志》2005年第6期822-823,826,共3页Journal of Tropical Medicine

摘　　要：目的分析乳胶层析法试纸条筛查HBsAg漏检的原因,为减少HBsAg漏检率,降低血液报废率提供依据。方法在室外采血时先用乳胶层析法试纸条筛查无偿献血人员HBsAg阴性后采血,采血后的样本用ELISA法采用两种不同厂家试剂进行HBsAg初复检,ELISA法检测阳性的血样本再用乳胶层析法做回顾性复检对照。结果采血后的无偿献血人员共3025人份血样本用ELISA法检测HBsAg,HBsAg阳性有57人份,乳胶层析试纸条在室外检测HBsAg漏检率1.88%;57份阳性样本再用乳胶层析法试纸条在室内做回顾性复检,复检HBsAg有56份阳性,回顾性复检对照符合率98.2%。56份HBsAg阳性其中11份强阳性样本在5min内判定结果占19.3%;21份阳性样本在10min内判定结果占36.8%;24份较弱阳性样本在15min内判定结果占42.1%。结论乳胶层析法试纸条在室外筛查HBsAg测试的时间未达到15min就判定结果是其漏检的主要原因,另外加入血量不足,加样过急血样品外溢造成试纸条检测区模糊不清也影响判定结果。乳胶层析法试纸条本身存在对弱阳性样本有漏检现象,有待日后厂家对产品质量的提高。Objective To find out why latex chromatogram test paper detection HBsAg gives false negative result. Method We first used latex chromatogram test paper to examine the blood and picked the HBsAg negatives outdoors, and the negatives were double examined by ELISA method with two different reagents, the rest positives were examined by latex chromatogram again for retrospective comparison. Results We use ELISA method to examine HBsAg in 3035 samples of blood donors. The positives were 57. The undetected rate of latex chromatogram test paper performed outdoors was 1.88%. And the test using the latex chromatogram test paper of these 57 positives samples were examined again indoors. 56 were positives, so the according rate was 98.2%. There were 11 presented strong positives in 5 rain, account for 19.3%; 21 presented positives in 10 min, account for 36.8%; 24 presented weak positives in 15 min, account for 42.1%. Conclusions The main reason of the false negative result of the latex chromatogram test paper was that the test was performed less than 15 rain outdoor. The latex chromatogram test paper therefore showed negative result for weak positives.

关 键 词：层析法 ELISA法 HBSAG 

分 类 号：R446.112[医药卫生—诊断学]