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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 evaluate the value of doim im-unobinding assay (DIBA) kit in clinical diagnosis and high-risk groups of liver disease and liver cancer. Methods Double-blind method was used to compare the results of field tests with other test kits. Results The sensitivity and specificity of DIBA were 100% compared with the clinical HBsAg and AFP results of 185 serum samples detected by the EIA kit. The compliance rate was 99.46%. The sensitivity, specificity, and coincidence rate of DIBA for detecting HBsAg were 99.10%, 88.6%, and 98.23%, respectively, compared with the results of EIA testing of 958 high-risk liver cancer patients; if AFP concentration was ≥20 μg, /L is the critical value for judging the positive. The sensitivity, specificity, and coincidence rate of DIBA for detecting AFP were 98.43%, 94.34%, and 99.67%, respectively. Conclusion The DIBA kit is specific, sensitive, simple, rapid, economical, etc. The test results can be stored for a long period of time. Two results can be obtained for one operation, and it will be widely used in clinical and population disease surveys.