国产与进口抗环瓜氨酸肽抗体试剂盒检测结果对比分析与应用研究

目的通过对国产与进口抗环瓜氨酸肽抗体（ACCP）检测结果的对比分析,以评估国产ACCP试剂对类风湿性关节炎（RA）的临床应用价值。方法用国产与EUROIMMUN公司ACCP试剂盒同时检测RA患者96例、非RA其他疾病患者44例和正常人对照血清40例,并进行比较,以评估国产ACCP试剂盒的诊断灵敏度、特异度和与进口同类试剂盒的相关性。结果国产和进口试剂盒检测ACCP在RA组中的阳性率为95.8%（92/96）和100%（96/96）,显著高于非RA其他疾病组的18.2%（8/44）和0.0%（0/44）及正常对照组的0.0%（〈0.001）,两种试剂定量值有差异（〈0.001）,但阳性率差异不显著（〉0.05）。国产与进口试剂在RA组有较高正相关（rs=0.881,〈0.001）,在非RA其他疾病组呈正相关（rs=0.499,=0.018）,正常对照组也呈正相关（rs=0.568,=0.009）。国产ACCP试剂盒对RA的诊断灵敏度和特异度分别为95.8%和90.5%,与进口同类试剂的一致性达93.3%。结论国产ACCP定量检测试剂盒与EUROIMMUN试剂盒有较好一致性,对RA的诊断特异度和灵敏度基本达到进口同类试剂水平,且成本低。ACCP是RA一个高特异性的血清学指标,对RA诊断与鉴别诊断有重要的临床意义。

The comparative analysis and the application results of domestic and imported antibodies of cyclic citrullinated peptide (ACCP)

Objective By comparative analyzing the test results of domestic and imported antibodies on cyclic citrullinated peptide(ACCP),we can assess the clinical values of domestic anti-CCP antibody reagents for the Rheumatoid Arthritis(RA).Methods The 96 cases patients with RA,44 cases patients with other non-RA diseases and 40 cases normal control were detected with domestic anti-CCP antibody and imported anti-CCP antibody produced by the EUROIMMUN Company at the same time,then we can get the diagnostic sensitivit...