两种方法检测RA患者血清抗CCP抗体的结果比对分析

Comparison of Two Methods for Detecting Serum Anti-CCP Antibodies in RA Patients

目的对比分析酶联免疫吸附法(ELISA)和胶乳免疫比浊法检测类风湿关节炎(RA)患者血清抗CCP抗体的测定结果。方法随机选择80例RA患者作为RA组,另选同期的80例非RA患者作为非RA组。所有受试者均于入院次日,分别采用ELISA和胶乳免疫比浊法测定血清中抗CCP抗体,比较两种检测方法的结果 ,及诊断准确性、特异性、灵敏度和结果一致性等。结果①ELISA检测抗CCP抗体结果显示真阳性78例,假阳性4例,真阴性76例,假阴性2例;胶乳免疫比浊法检测结果为真阳性72例,假阳性7例,真阴性73例,假阴性8例。②在160例受试者中,两种方法有153例受试者的抗CCP抗体检测结果一致,其中76例受试者均为阳性,77例受试者均为阴性,仅7例受试者检测结果不一致,一致率达到95.6%(153/160),Kappa值达到0. 914。比较不同水平间结果一致性,可见高水平的抗CCP抗体阳性一致率高,低水平的抗CCP抗体阴性一致率较高。③ELISA检测抗CCP抗体的准确性(96.3%)、特异性(95.0%)、灵敏度(97.5%)显著高于胶乳免疫比浊法(90.6%、91.3%、90.0%),χ~2值分别为4.373、3.817、5.955,P<0.05。结论 ELISA和胶乳免疫比浊法测定抗CCP结果一致性良好,二者各有优势,ELISA检测结果准确性、特异性和灵敏度稍高,临床应用过程中可根据需要选择检测方法 。

Objective To compare the test results of serum anti-CCP antibody in patients with rheumatoid arthritis (RA)by enzyme linked immunosorbent assay (ELISA)and latex immunoturbidimetry. Methods 80 RA patients admitted to our hospital from June,2016 to May,2017 were randomly selected as the RA group,while 80 healthy person who received physical examination during the same period were selected as the non-RA group. ELISA and latex immunoturbidimetry were both used to determine the levels of anti-CCP antibodies. And the diagnostic accuracy,specificity,sensitivity and consistency of the results were compared between the two groups. Results ① The ELISA results showed that 78 cases were true positive,4 cases of false positive,76 cases of true negative and 2 false negative,while latex immunoturbidimetry showed 72 cases of true positive,7 cases of false positive,73 cases of true negative,and 8 false negative.② Of the 160 patients,153 were detected with the same results by the two methods. Among them,76 were positive,77 were negative,and only 7 patients had the inconsistent results,with a consistent rate of 95.6%(153/160)and a kappa value of 0.914. Comparing the consistency of the results among different concentrations of anti-CCP antibody,it showed that the positive consistency rate of high concentration of anti-CCP antibody was higher,while the negative consistency rate of low concentration of anti-CCP antibody was higher.③ The accuracy of ELISA detection of anti-CCP antibodies (96.3%),specificity (95%)and sensitivity (97.5%)were all significantly higher than the latex immunoturbidimetry results (90.6%,91.3%,and 90%),and the χ 2 values were 4.373,3.817,5.955,respectively ( P <0.05). Conclusion There were good consistency between ELISA and latex immunoturbidimetry in the determination of anti-CCP. Given the unique advantage of each method,the ELISA detection is more accurate,specific and sensitive. Our study suggests that the detection method can be selected according to the needs in the clinical application.