2种检测方法在类风湿关节炎抗环瓜氨酸肽抗体检测中临床价值比较

摘要

目的：比较化学发光微粒子免疫（CMIA）测定法与酶联免疫吸附试验（ELISA）法检测抗环瓜氨酸肽（CCP）抗体，在类风湿关节炎（RA）诊断中的临床应用价值。方法采用 CMIA 法与 ELISA 法分别检测895例研究对象的抗 CCP 抗体，其中包括 RA 患者252例，骨关节炎112例，结缔组织37例，系统性红斑狼疮39例，骨质疏松46例，其他疾病329例，80例健康对照者。结果 CMIA 法检测抗 CCP 抗体的精密度批内、批间变异系数分别为1．7％、2．9％；2种方法检测抗 CCP 抗体符合率为90．0％。CMIA 法检测高浓度抗 CCP 抗体血清样本稀释验证结果显示，标本浓度稀释至1∶160线性 R 值仍均大于0．9。 CMIA 法检测RA 阳性为183例（72．61％），骨关节炎阳性65例（58．04％），结缔组织病阳性为12例（32．43％），系统性红斑狼疮阳性16例（41．02％），骨质疏松阳性9例（19．56％），其他疾病阳性16例（4．86％）。在 ELISA 法检测中，骨质疏松阳性12例（26．08％），灵敏度略高于 CMIA 法，其余灵敏度均低于 CMIA 法。80例为健康对照者在2种方法检测中均为阴性。结论 CMIA 法对 RA 诊断的灵敏度、特异度与 ELISA 法具有较好的一致，值得临床推广应用。%Objective To compare chemiluminescence immunoassay (CMIA ) method and enzyme linked immunosorbent assay (ELISA) in anti‐cyclic citrullinated peptide antibody (anti‐CCP)detection in rheumatoid arthritis (RA ) patients .Methods The CMIA method and ELISA were used to detect the anti‐CCP in 895 people ,including 252 RA patients ,112 patients with osteoarthri‐tis ,37 connective tissue patients ,39 systemic lupus erythematosus patients ,46 osteoporosis patients ,329 patients with other disease and 80 healthy controls .Results The batch precision and inter assay coefficients of variation of CMIA method for the detection of anti‐CCP were 1 .7% ,2 .9% .The coincidence rate of CMIA and ELISA method was 90 .0% .CMIA method for detection of high level of serum anti‐CCP in the sample dilution experiment results showed that the concentration of the sample was diluted to 1 ∶160 ,linear R value was greater than 0 .9 .CMIA method and ELISA method for detection of anti CCP antibody related test results showed that the CMIA method for detection of rheumatoid arthritis (RA) patients of 252 cases ,positive in 183 cases (72 .61% ) ;112 patients with osteoarthritis ,positive in 65 cases (58 .04% ) ;connective tissue in 37 cases ,positive in 12 cases (32 .43% ) ;39 pa‐tients with systemic lupus erythematosus ,positive in 16 cases (41 .02% ) ;osteoporosis in 46 cases ,positive in 9 cases (19 .56% ) ;other diseases in 329 cases ,16 cases were positive (4 .86% ) .In the ELISA assay ,osteoporosis in 46 cases ,12 cases were positive (26 .08% ) sensitivity was slightly higher in the CMIA method ,CMIA method were lower than the rest of the sensitivity .80 cases of healthy controls were detected in two kinds of methods were negative .Conclusion The sensitivity and specificity of CMIA meth‐od is consistent with ELISA method in the diagnosis of RA ,which is worthy of promotion in clinic .