Department of Laboratory Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Korea.
Clin Chem Lab Med. 2010 Feb;48(2):225-30. doi: 10.1515/CCLM.2010.046.
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.
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.
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.
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.
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。
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。
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%。
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。
