药物(奎宁)依赖性血小板抗体检测技术的建立及国际合作评估

Establishment and international evaluation of drug- dependent platelet antibodies testing

目的建立药物(奎宁)依赖性血小板抗体检测的技术并组织国际实验室进行评估。方法建立药物依赖性抗体流式细胞术及药物依赖性抗体血小板抗原单克隆抗体特异性免疫固定检测技术,向各参与的实验室提供检测方案,奎宁依赖性血小板抗体血清、血小板糖蛋白单克隆抗体、阴性对照及药物奎宁,各实验室按照给定的方案对样本进行检测,对结果做统计比较。结果参加评估实验室对3个评估样本检测的准确率:药物依赖性抗体流式细胞术分别为91.67%,100%,91.67%;药物依赖性抗体血小板抗原单克隆抗体特异性免疫固定检测技术均为100%。所建立的2种检测技术,经国际23家实验室评估,获得良好的灵敏度和特异性。结论该技术可应用于药物诱导免疫性血小板减少症的实验室诊断。

Objective To establish drug- dependent antibodies（ DDAb）testing methods,and to organize international labs for evaluation of the methods. Methods Flow cytometric assay for drug- dependent platelet antibodies（ FCM- DDAb） and monoclonal antibody- specific immobilization of platelet antigens assay for drug- dependent platelet antibodies（ MAIPA- DDAb） were established for DDAb testing. Serum samples containing quinine- dependent antibodies,normal serum sample,m Abs,quinine,FCM- DDAb and MAIPA- DDAb protocols were sent to international collaborators who were asked to test the samples with the protocols provided. The test results from collaborators were evaluated. Results For the test of three samples,the accuracy of FCM- DDAb test results was 91. 67%,100% and 91. 67%,respectively,while the accuracy of MAIPA- DDAb test results was 100%. Both of DDAb testing methods show good sensitivity and specificity on drug- dependent platelet antibodies testing. Conclusion It can be used for laboratory diagnosis of drug- induced immune thrombocytopenia.