BP180NC16a-ELISA检测大疱性类天疱疮多中心随机双盲对照试验

目的 探讨BP180抗体诊断试剂盒检测大疱性类天疱疮（BP）的灵敏度和特异度。方法 多中心随机双盲平行对照临床试验。使用BP180抗体诊断试剂盒（ELISA）检测106例临床已经确诊的活动期BP患者和106例对照人群（含非BP的其他大疱性疾病以及硬皮病、银屑病、SLE、妊娠晚期孕妇、健康献血员等）血清样本，并与间接免疫荧光（IIF）试验进行灵敏度和特异度的对比。结果 106份BP患者血清样本中81份BP180抗体诊断试剂盒为阳性，其灵敏度为76.4%；83份抗表皮抗原抗体检测试剂盒（IIF法）为阳性，其灵敏度为78.3%。106份对照组血清标本中95份BP180抗体诊断试剂盒为阴性，其特异度为89.6%；102份抗表皮抗原抗体检测试剂盒为阴性，其特异度为96.2%。BP180抗体诊断试剂盒（ELISA）与对照试剂盒的灵敏度和特异度相比较，差异无统计学意义（P > 0.05）。结论 BP180抗体诊断试剂盒可作为诊断BP的一种辅助手段。

A multi-center, randomized, double-blind and controlled study of BP180NC16a enzyme-linked immu-nosorbent assay (BP180NC16a-ELISA) in the diagnosis of bullous pemphigoid

Objective To evaluate the sensitivity and specificity of BP180NC16a-ELISA in the diagnosis of bullous pemphigoid (BP). Methods A multi-center, randomized, double-blind, parallel-controlled study was conducted. Sera were collected from 106 patients with clinically confirmed active BP and 106 control subjects including patients with non-BP bullous diseases, scleroderma, psoriasis or systemic lupus erythematosus,late pregnant women and healthy blood donors. BP180NC16a-ELISA was performed on these sera. The IgG antibody levels measured by ELISA kit were compared with those measured by indirect immunofluorescence (IIF) test. Results Of the 106 BP sera, 81 were positive for BP180NC16a-ELISA with a sensitivity of 76.4%,83 for ⅡF test with a sensitivity of 78.3%. Among the 106 control serum samples, 95 were negative for BP180NC16A-ELISA with a specificity of 89.6%, and 102 for ⅡF test with a specificity of 96.2%. There was no significant difference between the two tests in dignostic sensitivity and specificity for BP (both P ＞ 0.05).Conclusion BP180NC16A-ELISA may serve as an adjuvant tool for the diagnosis of BP.