Abstract

To determine the analytical performance of Novel VITROS BRAHMS Procalcitonin Immunoassay on VITROS 3600 and correlation with BRAHMS PCT sensitive KRYPTOR reference method. Analytical performances including imprecision studies, linearity, limit of detection (LoD) and determination of hemolysis index were performed for VITROS BRAHMS PCT assay. Imprecision was assessed on plasma pool and internal control with 2 levels. The method comparison was performed using 162 plasma obtained from clinical departments. The total imprecision was acceptable and all CV were <5%. The LoD was in accordance with manufacturer’s claims. The equation of linearity in the lower range was found to be y = 1.0014x – 0.0091, with r² = 1. No interference to hemoglobin up to 11 g/L was observed. Correlation studies showed a good correlation between PCT measurements using VITROS BRAHMS PCT assay against KRYPTOR system including for values lower than 2 µg/L. The novel VITROS BRAHMS PCT assay from OrthoClinical Diagnostics shows analytical performances acceptable for clinical use. In addition, the concordance with KRYPTOR method was fine at all clinical cut-offs.

摘要

确定新型 VITROS BRAHMS 降钙素原免疫测定在 VITROS 3600 上的分析性能以及与 BRAHMS PCT 敏感的 KRYPTOR 参考方法的相关性。对 VITROS BRAHMS PCT 测定进行了分析性能，包括不精确研究、线性、检测限 (LoD) 和溶血指数的测定。在血浆池和内部对照的 2 个水平上评估不精确性。使用从临床科室获得的 162 份血浆进行了方法比较。总的不精密度是可以接受的，所有的 CV 都 <5%。LoD 与制造商的声明一致。发现较低范围内的线性方程为y  = 1.0014 x – 0.0091，其中 r ²= 1. 未观察到对高达 11 g/L 的血红蛋白的干扰。相关性研究表明，使用 VITROS BRAHMS PCT 测定法对 KRYPTOR 系统的 PCT 测量值之间具有良好的相关性，包括低于 2 µg/L 的值。来自 OrthoClinical Diagnostics 的新型 VITROS BRAHMS PCT 检测显示出临床使用可接受的分析性能。此外，与 KRYPTOR 方法的一致性在所有临床截止点上都很好。