Comparison of chemiluminescence enzyme immunoassay (CLEIA) with ELISA for the determination of anti-cyclic citrullinated peptide antibodies.
Comparison of chemiluminescence enzyme immunoassay (CLEIA) with ELISA for the determination of anti-cyclic citrullinated peptide antibodies.
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DOI：
10.1016/j.cca.2009.09.032
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发表时间：
2010-01
期刊：
影响因子：
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通讯作者：
R. Tanaka;M. Takemura;Masao Sato;Yasunori Yamada;Takahito Nakagawa;Takuro Horibe;Masato Hoshi;
中科院分区：
文献类型：
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作者：
R. Tanaka;M. Takemura;Masao Sato;Yasunori Yamada;Takahito Nakagawa;Takuro Horibe;Masato Hoshi;
研究背景抗环瓜氨酸肽（抗CCP）自身抗体是类风湿关节炎（RA）的敏感和高度特异性标志物。评价化学发光酶免疫法（CLEIA）检测抗CCP抗体的准确性，并与ELISA法进行比较。方法99例RA患者，16例骨关节炎患者，94例健康人。结果表明：CLEIA法检测抗CCP抗体的变异系数（CV）为4.0%，最低检测限为0.1U/ml; CLEIA法检测抗CCP抗体的CV为21.17%，最低检测限为5.3%;抗CCP抗体CLEIA（x）与ELISA（y）的相关性为y=1.08x+4.171，r=0.9178（p<0.0001）。CLEIA和ELISA的敏感性和特异性无差异。结论CLEIA自动化处理系统用于检测抗CCP抗体显示了良好的分析性能，并建议CLEIA系统有潜力在短时间内提供临床有用的数据。
BACKGROUNDAutoantibodies against cyclic citrullinated peptide (anti-CCP) are sensitive and highly specific markers for rheumatoid arthritis (RA). We evaluated the analytical and diagnostic accuracy of chemiluminescence enzyme immunoassay (CLEIA) for anti-CCP antibodies, and compared it with that of ELISA.METHODSNinety-nine RA patients who were diagnosed according to the American College of Rheumatology criteria, 16 patients with osteoarthritis, and 94 healthy subjects were included. Sera were used to assess the precision, functional sensitivity, and linearity of anti-CCP antibody determination by CLEIA and the correlation of anti-CCP antibody values between CLEIA and ELISA.RESULTSFor anti-CCP antibodies by CLEIA, the total CV was 4.0 and 5.3% at 21.17 and 90U/ml, respectively, and the lower limit of detection was 0.1U/ml. The correlation of CLEIA (x) with ELISA (y) for anti-CCP was: y=1.08x+4.171, r=0.9178 (p<0.0001). No difference was observed in the sensitivity and specificity between CLEIA and ELISA.CONCLUSIONSThe automated CLEIA processing system for determining anti-CCP antibodies showed a good analytical performance, and suggested that the CLEIA system has a potential to provide clinically useful data within a short time.