CAJ | 학술논문

目的：比较酶联免疫吸附试验（ELISA）法和胶乳免疫比浊法检测血清抗环瓜氨酸肽（抗-CCP）抗体对 RA 患者的诊断价值和临床适用性。方法收集西安市风湿病研究所2014年12月～2015年2月期间住院患者的新鲜血清267份，另选陕西省血液中心健康献血员新鲜血清50例，分别用酶联免疫吸附试验（ELISA）法和胶乳免疫比浊法检测抗 CCP 抗体，评价两种方法结果的相关性及其对 RA 诊断的临床适用性。结果ELISA 和胶乳免疫比浊法的敏感度、特异度和诊断一致性分别为77.3％，86.8％，94.3％和76.2％，80.2％，77.9％；两种方法比较 Kappa 值为0.756，二者具有一致性；对两组数据进行χ2检验，χ2＝1.85，P ＞0.05，方法间比较差异无统计学显著性意义；ELISA 和胶乳免疫比浊法 ROC 曲线下面积分别是0.876和0.832。结论血清抗 CCP 抗体检测对 RA 患者具有一定的诊断价值，ELISA 法和胶乳免疫比浊法检测抗 CCP 抗体具有一致性。两种方法学之间无统计学差异，胶乳免疫比浊法更适合于基层医疗机构的应用。
목적：비교매련면역흡부시험（ELISA）법화효유면역비탁법검측혈청항배과안산태（항-CCP）항체대 RA 환자적진단개치화림상괄용성。방법수집서안시풍습병연구소2014년12월～2015년2월기간주원환자적신선혈청267빈，령선합서성혈액중심건강헌혈원신선혈청50례，분별용매련면역흡부시험（ELISA）법화효유면역비탁법검측항 CCP 항체，평개량충방법결과적상관성급기대 RA 진단적림상괄용성。결과ELISA 화효유면역비탁법적민감도、특이도화진단일치성분별위77.3％，86.8％，94.3％화76.2％，80.2％，77.9％；량충방법비교 Kappa 치위0.756，이자구유일치성；대량조수거진행χ2검험，χ2＝1.85，P ＞0.05，방법간비교차이무통계학현저성의의；ELISA 화효유면역비탁법 ROC 곡선하면적분별시0.876화0.832。결론혈청항 CCP 항체검측대 RA 환자구유일정적진단개치，ELISA 법화효유면역비탁법검측항 CCP 항체구유일치성。량충방법학지간무통계학차이，효유면역비탁법경괄합우기층의료궤구적응용。
Objective To compare diagnosis value and the clinical application of enzyme linked immunosorbent assay (ELISA) method and the immune turbidimetric method detecting serum anti cyclic citrullinated peptide (CCP)antibody in patients with RA.Methods Collected fresh serum specimen of 267 inpatients with RA in Rrheumatism Department of Xi’an Institu-te of Rheumatism from December 2014 to February 2015,and fresh serum specimen of 50 healthy blood donors from the Blood Center of Shaanxi Province respectively.Anti CCP antibody was detected by enzyme-linked immunosorbent assay (ELISA)method and the latex immunoturbidimetry assay.Evaluated the correlation of the results and clinical application to RA diagnosis.Results Sensitivity,specificity and diagnostic consistency of ELISA and latex immunoturbidimetry assay were 77.3%,86.8%,94.3% and 76.2%,80.2%,77.9% respectively.Compared two kinds of methods,the value of Kappa was 0.756,for having consistency.Throughχ2 test (χ2 =1.85,P >0.05),there was no significant difference between two meth-ods.Area of ELISA and lateximmunoturbidimetry under the ROC curve were 0.876 and 0.832 respectively.Conclusion De-tection of serum anti CCP antibody has diagnostic value in RA patients.The ELISA method and the latex immunoturbidime-try assay for detection of anti CCP antibodies had consistency.Two methods had no statistical difference,and the latex turbi-dimetric method is suitable for grassroots medical institutions.