胶体金检测抗环瓜氨酸肽抗体性能评价

Performance Evaluation of Colloidal Gold Test for the Detection of Anti-cyclic Citrullinated Peptide Antibody

目的对胶体金免疫层析(GICA)技术检测患者血清抗环瓜氨酸肽(CCP)抗体进行性能验证和评价。方法采用酶联免疫吸附试验(ELISA)和GICA,同时对104例可疑类风湿性关节炎(RA)患者进行抗-CCP抗体检测,计算两种方法检测结果的阴性符合率、阳性符合率、总符合率以及Kappa值。用±20%临界值浓度标本各重复检测20次,记录阴性和阳性结果数,验证GICA法重复性。结果两种方法检测结果比较,阴性符合率、阳性符合率、总符合率、Kappa值分别为92%、100%、96%、0.92。GICA法检测+20%临界值浓度标本结果阳性数为20次,阳性率100%;-20%临界值浓度标本结果阴性数为15次,阴性率为75%。结论 GICA法与ELISA法检测抗-CCP抗体结果一致性良好,而且GICA方法简单、快速,敏感性和特异性较高,是早期筛查类风湿性关节炎值得推广的方法。

Objective To verify and evaluate the performance of the anti-cyclic citrullinated peptide antibody （ CCP ） by the rapid colloidal gold immunoehromatographie strip. Methods All 104 serum samples were detected parallelly by ELISA and GICA, calculating the negative rate, the positive rate, the total rate and Kappa value. The samples of ＋ 20% concentration of cutoff were detected 20 times repeatedly, recording the positive and negative number. Results The negative rate, the positive rate, the total rate and Kappa value of the two test were 92%, 100%,96% and 0.92. The positive rate of ＋20% concentration of cutoff was 100% , and the negative rate of -20% concentration of cutoff was 75%. Conclusion The consistency of the ELISA and GICA for the anti-cyclic citrullinated peptide antibody is good. GICA kit is simple and easy to operate, relatively high sensitivity and specificity. It is a useful assay in the clinical early screening inspecting of RA.