直接化学发光法检测抗环瓜氨酸肽抗体的应用评估

Evaluation of direct chemiluminescence immunoassay in detection of anti-cyclic citrullinated peptide antibodies

目的:评估直接化学发光免疫分析法(CLIA)检测血清抗环瓜氨酸肽(抗CCP)抗体的临床应用。方法:用直接CLIA、酶联免疫吸附试验(ELISA)同时检测RA患者56例、非RA其他疾病患者69例和正常对照35例血清中的抗CCP抗体。结果:直接CLIA法检测抗CCP抗体的批内变异系数为2.5%～3.8%、批间变异系数为2.8%～5.2%,明显低于ELISA法(5.6%～6.9%,6.7%～8.2%)。直接CLIA法检测抗CCP抗体的平均回收率为99.5%。对RA诊断的敏感性为73.2%,特异性为96.2%,与ELISA法检测结果总体符合率达96.9%。结论:采用直接CLIA法检测抗CCP抗体具有较高的敏感性和特异性,可满足临床需要。

Objective：To evaluate the clinical application of the anti-cyclic citrullinated peptide（CCP）antibody by direct Chemiluminescence Immunoassay（CLIA）.Methods：Anti-ccp antibody level was measured simultaneously by direct CLIA and ELISA in 56 patients with rheumatoid arthritis（RA）,69 patients with other rheumatic diseases and 35 halthy persons.Results：The intra-and inter-CV values of direct CLIA were 2.5%~3.8% and 2.8%~5.2% respectively,significantly lower than that of ELISA（5.6%~6.9%,6.7%~8.2%）.The mean recovery rate of direct CLIA was 99.5%.The sensitivity and specificity of direct CLIA were 73.2% and 96.2% respectively in diagnosis of RA,and the total coincidence rates with ELISA was 96.9%.Conclusion：Anti-ccp antibody assay by direct CLIA showed high reproducibility,more sensitivity and higher specificity for rheumatoid arthritis,so it could be used in clinical diagnosis and research.