国产抗环瓜氨酸肽抗体试剂盒在类风湿关节炎诊断中的应用价值

The evaluation of the anti-cyclic citrullinated peptide antibody reagent kit made in China in the diagnosis of rheumatoid arthritis

目的检测类风湿关节炎(RA)患者以及非RA的自身免疫性疾病患者血清中环瓜氨酸肽(CCP)抗体,探讨国产抗CCP抗体试剂盒在RA诊断中的敏感性和特异性。方法用酶联免疫吸附试验(ELISA)分别检测209例RA患者,82例非RA的其他自身免疫性疾病患者以及154名正常体检者的抗CCP抗体。结果以正常体检者组为对照,RA患者组抗CCP抗体的敏感性为72.25%,特异性为98.7%,阳性预测值为98.7%,阴性预测值为72.3%。以非RA自身免疫性疾病患者组为对照,RA患者组抗CCP抗体的敏感性为72.25%,特异性为76.83%,阳性预测值为88.8%,阴性预测值为52.0%。结论该抗CCP抗体的试剂盒对RA的诊断具有较高的敏感性和特异性,且操作简便,成本较低,有较高的临床应用价值。

Objective To observe the sensitivity and specificity of the anti-cyclic citrullinated peptide（CCP） antibody reagent kit in the diagnosis of rheumatoid arthritis （RA） by analyzing the anti-CCP in patients with RA and autoimmune diseases patients without RA. Methods Serum anti-CCP was determined by enzyme-linked immunosorbent assay （ELISA） in 209 RA patients, 82 non-RA patients and 154 normal control subjects. Results Comparing with the normal control subjects, the sensitivity and specificity of anti-CCP in the RA patients were 72.25% and 98.7%, and the positive and negative predictive values were 98.7% and 72.3%, respectively. Comparing with the non-RA patients, the sensitivity and specificity were 72.25% and 76.83% and the positive and negative predictive values were 88.8% and 52.0%, respectively. Conclusions The anti-CCP reagent kit made in China has better sensitivity and specificity in diagnosis of RA and higher clinical application value because of its easier operation and low cost.