应用点免疫结合法同时测定HBsAg和AFP方法的评估

APPLICATION OF DOT IMMUNOBINDING ASSAY FOR SIMULTANEOUS DETECTION OF HEPATITIS B SURFACE ANTIGEN(HBsAg) AND ALPHA-FETOPROTEIN(AFP)

目的 评价点免疫结合法（ｄｏｔｉｍ ｍ ｕｎｏｂｉｎｄｉｎｇａｓｓａｙ，ＤＩＢＡ）试剂盒在临床诊断及肝病、肝癌高危人群的应用价值。方法 采用双盲法，实地与其它检测试剂盒检测的结果比较。结果 与ＥＩＡ 试剂盒检测的临床１８５份血清ＨＢｓＡｇ 和ＡＦＰ结果比较，ＤＩＢＡ 的敏感度和特异性为１００％ ，符合率为９９．４６％ 。与ＥＩＡ检测９５８ 份肝癌高危人群的血清的结果比较，ＤＩＢＡ检测ＨＢｓＡｇ 的敏感度、特异度和符合率分别为９９．１０％ 、８８．６％ 和９８．２３％ ；如以ＡＦＰ浓度≥２０ μｇ／Ｌ为判断阳性的临界值，ＤＩＢＡ检测ＡＦＰ的灵敏度、特异度和符合率分别为９８．４３％ 、９４．３４％和９９．６７％ 。结论 ＤＩＢＡ试剂盒具有特异、敏感、简单、快速、经济等特点，检测结果可长期保存，一次操作可获两项结果，在临床和人群疾病普查中将有广泛的推广应用价值。

Objective To assess the reliability of the diagnostic kit by simultaneous detection of HBsAg and AFP in high risk hepafocarcinoma.Methods The results were compared with other diagnostic kit by double blind method.Results By comparing with the results of EIA detection for 185 clinical sera,the sensitivity rate,the specificity rate and the coincidence rate were 100%,100% and 99.46% respectively.By comparing with the results of HBsAg EIA kit(ABBOTT,U.S.A.) detection in 958 sera from high risk group of hepatocarcinona,the sensitivity rate,the specificity rate and the coincidence rate for HBsAg were 99.10%,88.6% and 98.23% respectively.If the value of AFP≥20ng/ml was looked as positive,the sensitivity rate, the specificity rate and the coincidence rate of DIBA were 98.43%,94.34% and 99.67% respectively.Conclusion The results showed that the kit is rapid,simple,sensitive, economic and reliable.The original results of test can be preserved for a long time, and two parameters can be obtained at the same time by only one test.It is suggested that this technique should have broard application in screening of large numbers of sera under field trial conditions and routine sera screening in clinical laboratory.