ARCHITECT 抗环瓜氨酸肽抗体在类风湿关节炎诊断中的性能分析。
Performance analysis of the ARCHITECT anti-cyclic citrullinated peptide antibody in the diagnosis of rheumatoid arthritis.
机构信息
Department of Laboratory Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Korea.
出版信息
Clin Chem Lab Med. 2010 Feb;48(2):225-30. doi: 10.1515/CCLM.2010.046.
BACKGROUND
Anti-cyclic citrullinated peptide (CCP) antibody is emerging as an important diagnostic marker for rheumatoid arthritis (RA). We evaluated the analytical and diagnostic performance of the ARCHITECT anti-CCP (Abbott Diagnostics), a new fully automated chemiluminescent microparticle immunoassay.
METHODS
Serum samples from 69 patients with RA and 86 non-RA patients were used to evaluate the performance of the ARCHITECT anti-CCP assay, and the results were compared with those of EliA CCP (Phadia). The optimal cut-off value was calculated using receiver operating characteristic (ROC) curve analysis.
RESULTS
Within-run and total imprecision (%CV) of the ARCHITECT anti-CCP were <6% and good linearity was observed over the claimed range. The areas under the ROC curves for the ARCHITECT anti-CCP and EliA CCP were 0.90 and 0.89, respectively. The sensitivity and specificity were 76.8% and 95.3% for the ARCHITECT anti-CCP and 78.3% and 95.3% for EliA CCP using the manufacturer's cut-off thresholds. Both assays showed sensitivity of 84.1% and specificity of 94.2% using the optimal cut-off values.
CONCLUSIONS
The analytical performance of the ARCHITECT anti-CCP was satisfactory and diagnostic performance was comparable to that of EliA CCP. The use of optimal cut-off thresholds can yield higher sensitivity with minimal loss of specificity.
背景
抗环瓜氨酸肽（CCP）抗体作为类风湿关节炎（RA）的重要诊断标志物正在兴起。我们评估了ARCHITECT 抗 CCP（雅培诊断）的分析和诊断性能，这是一种新的全自动化学发光微粒子免疫分析。
方法
使用 69 例 RA 患者和 86 例非 RA 患者的血清样本评估 ARCHITECT 抗 CCP 检测的性能，并将结果与 EliA CCP（Phadia）进行比较。使用接收者操作特征（ROC）曲线分析计算最佳临界值。
结果
ARCHITECT 抗 CCP 的批内和总不精密度（%CV）<6%，在宣称的范围内观察到良好的线性。ARCHITECT 抗 CCP 和 EliA CCP 的 ROC 曲线下面积分别为 0.90 和 0.89。使用制造商的临界值，ARCHITECT 抗 CCP 的灵敏度和特异性分别为 76.8%和 95.3%，EliA CCP 为 78.3%和 95.3%。使用最佳临界值，两种检测方法的灵敏度均为 84.1%，特异性均为 94.2%。
结论
ARCHITECT 抗 CCP 的分析性能令人满意，诊断性能与 EliA CCP 相当。使用最佳临界值可以提高灵敏度，同时最小化特异性损失。
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