Department of Biotechnology, University of Turku, Turku, Finland.
Cancer Research and Translational Medicine Research Unit, Department of Clinical Chemistry, University of Oulu, Kajaanintie 50, 90220, Oulu, Finland.
Sci Rep. 2021 Sep 21;11(1):18698. doi: 10.1038/s41598-021-98199-y.
Measurement of cardiac troponin I (cTnI) should be feasible for point-of-care testing (POCT) to diagnose acute myocardial infarction (AMI). Lateral flow immunoassays (LFIAs) have been long implemented in POCT and clinical settings. However, sensitivity, matrix effect and quantitation in lateral flow immunoassays (LFIAs) have been major limiting factors. The performance of LFIAs can be improved with upconverting nanoparticle (UCNP) reporters. Here we report a new methodological approach to quantify cTnI using UCNP-LFIA technology with minimized plasma interference. The performance of the developed UCNP-LFIA was evaluated using clinical plasma samples (n = 262). The developed UCNP-LFIA was compared to two reference assays, the Siemens Advia Centaur assay and an in-house well-based cTnI assay. By introducing an anti-IgM scrub line and dried EDTA in the LFIA strip, the detection of cTnI in plasma samples was fully recovered. The UCNP-LFIA was able to quantify cTnI concentrations in patient samples within the range of 30-10,000 ng/L. The LoB and LoD of the UCNP-LFIA were 8.4 ng/L and 30 ng/L. The method comparisons showed good correlation (Spearman's correlation 0.956 and 0.949, p < 0.0001). The developed UCNP-LFIA had LoD suitable for ruling in AMI in patients with elevated cTnI levels and was able to quantify cTnI concentrations in patient samples. The technology has potential to provide simple and rapid assay for POCT in ED setting.
测量心肌肌钙蛋白 I（cTnI）应该可以通过即时检验（POCT）来诊断急性心肌梗死（AMI）。侧向流动免疫分析（LFIAs）长期以来一直应用于 POCT 和临床环境中。然而，侧向流动免疫分析（LFIAs）的灵敏度、基质效应和定量一直是主要的限制因素。上转换纳米粒子（UCNP）报告器可以提高 LFIAs 的性能。在这里，我们报告了一种使用 UCNP-LFIA 技术定量检测 cTnI 的新方法，该方法最大限度地减少了血浆干扰。使用临床血浆样本（n=262）评估了所开发的 UCNP-LFIA 的性能。将开发的 UCNP-LFIA 与两种参考测定法（西门子 Advia Centaur 测定法和内部基于孔的 cTnI 测定法）进行了比较。通过在 LFIA 条带中引入抗 IgM 冲洗线和干燥的 EDTA，可以完全恢复对血浆样品中 cTnI 的检测。UCNP-LFIA 能够在 30-10,000ng/L 的范围内定量患者样品中的 cTnI 浓度。UCNP-LFIA 的 LoB 和 LoD 分别为 8.4ng/L 和 30ng/L。方法比较显示出良好的相关性（Spearman 相关系数为 0.956 和 0.949，p<0.0001）。所开发的 UCNP-LFIA 的 LoD 适合用于检测升高的 cTnI 水平的患者中的 AMI，并且能够定量患者样品中的 cTnI 浓度。该技术有可能为 ED 环境中的 POCT 提供简单快速的检测方法。
