电化学发光免疫测定法检测抗环瓜氨酸肽抗体的方法比较

Comparison of electrochemiluminescence immunoassay with enzyme linked immunosorbent assay for the measurement of anti-cyclic citrullinated peptide antibody

目的：比较电化学发光免疫测定（ECLIA）法与酶联免疫吸附试验（ELISA）法检测抗环瓜氨酸肽（抗CCP）抗体的价值。方法：采用ECLIA法和ELISA法分别检测192例类风湿关节炎（RA）患者、56例其他风湿性疾病患者及100名健康对照者血清中的抗CCP抗体,观察ECLIA法检测抗CCP抗体的精密度、回收率、诊断灵敏度、诊断特异度,并分析ECLIA法与ELISA法间的相关性。结果：ECLIA法检测抗CCP抗体的批内、批间变异系数分别为0.9%~1.8%、1.7%~2.4%,明显低于ELISA法（5.8%~8.6%,6.7%~9.8%）（P〈0.01）。ECLIA法检测抗CCP抗体的回收率为96.7%~98.6%,灵敏度和特异度分别为72.9%、98.7%,与ELISA法检测结果的一致率达96.7%。结论：ECLIA法检测抗CCP抗体的精密度较高,且对RA诊断的灵敏度、特异度与ELISA法具有较好的一致性。

Objective To compare the measurement of anti-cyclic citrullinated peptide（CCP） antibody by electrochemiluminescence immunoassay（ECLIA） with that by ELISA.Methods Anti-CCP antibody level was measured simultaneously by ECLIA and ELISA in 192 patients with rheumatoid arthritis（RA）,56 patients with other rheumatic diseases and 100 healthy controls.The parameters of ECLIA assay,including precision,recovery rate,sensitivity,and specificity were evaluated and their correlations with ELISA were analyzed.Results The intra-batch and inter-batch coefficient of variation of ECLIA were 0.9%-1.8% and 1.7%-2.4%,respectively,significantly lower than that of ELISA（5.8%-8.6%,6.7%-9.8%）（P0.01）.The recovery rate of ECLIA assay was 96.7%-98.6%;sensitivity and specificity were 72.9% and 98.7%,respectively.The consistent rate with ELISA was 96.7%.Conclusions ECLIA assay is a new technique with high precision for the measurement of anti-CCP antibody level,and having high sensitivity and specificity for the diagnosis of RA.