Departments of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Petersgraben 4, 4031, Basel, Switzerland.
University of Basel, Basel, Switzerland.
Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.
The aim of this study was to correlate three commercially available copeptin assays and their diagnostic accuracy in the differential diagnosis of the polyuria-polydipsia syndrome. Analyzed data include repeated copeptin measures of 8 healthy volunteers and 40 patients with polyuria-polydipsia syndrome undergoing osmotic stimulation and of 40 patients hospitalized with pneumonia. Copeptin was measured using the automated Brahms KRYPTOR, the manual Brahms LIA and the manual Cloud Clone ELISA assay. Primary outcome was the interrater correlation coefficient (ICC) and diagnostic accuracy in the polyuria-polydipsia syndrome of the three assays. In healthy volunteers, there was a moderate correlation for the KRYPTOR and LIA (ICC 0.74; 95% CI 0.07 to 0.91), and a poor correlation for the KRYPTOR and ELISA (ICC 0.07; 95% CI - 0.06 to 0.29), as for the LIA and ELISA (ICC 0.04; 95% CI - 0.04 to 0.17). The KRYPTOR had the highest diagnostic accuracy (98% (95% CI 83 to100)), comparable to the LIA (88% (95% CI 74 to 100)), while the ELISA had a poor diagnostic accuracy (55% (95% CI 34 to 68)) in the differential diagnosis of the polyuria-polydipsia syndrome. The KRYPTOR and LIA yield comparable copeptin concentrations and high diagnostic accuracy, while the ELISA correlates poorly with the other two assays and shows a poor diagnostic accuracy for polyuria-polydipsia patients. The current copeptin cut-off is valid for the KRYPTOR and LIA assay. Our results indicate that interpretation with other assays should be performed with caution and separate validation studies are required before their use in differentiating patients with polyuria-polydipsia syndrome.Trial registration: NCT02647736 January 6, 2016/NCT01940614 September 12, 2013/NCT00973154 September 9, 2009.
本研究旨在比较三种市售 copeptin 检测方法，并评估其在多尿多饮综合征鉴别诊断中的诊断准确性。分析数据包括 8 名健康志愿者和 40 名接受渗透刺激的多尿多饮综合征患者以及 40 名住院肺炎患者的重复 copeptin 测量值。copeptin 采用自动化 Brahms KRYPTOR、手动 Brahms LIA 和手动 Cloud Clone ELISA 检测法进行检测。主要结局是三种检测方法在多尿多饮综合征中的组内相关系数（ICC）和诊断准确性。在健康志愿者中，KRYPTOR 和 LIA 之间的相关性为中度（ICC 0.74；95%CI 0.07 至 0.91），而 KRYPTOR 和 ELISA 之间的相关性为差（ICC 0.07；95%CI -0.06 至 0.29），LIA 和 ELISA 之间的相关性为差（ICC 0.04；95%CI -0.04 至 0.17）。KRYPTOR 的诊断准确性最高（98%（95%CI 83 至 100）），与 LIA 相当（88%（95%CI 74 至 100）），而 ELISA 的诊断准确性较差（55%（95%CI 34 至 68）），用于多尿多饮综合征的鉴别诊断。KRYPTOR 和 LIA 产生可比的 copeptin 浓度和高诊断准确性，而 ELISA 与其他两种检测方法相关性较差，对多尿多饮综合征患者的诊断准确性较差。目前的 copeptin 截止值适用于 KRYPTOR 和 LIA 检测法。我们的结果表明，在其他检测方法的解读中应谨慎进行，并在其用于鉴别多尿多饮综合征患者之前需要进行单独的验证研究。试验注册：NCT02647736 2016 年 1 月 6 日/NCT01940614 2013 年 9 月 12 日/NCT00973154 2009 年 9 月 9 日。
