Background: We aimed to evaluate the analytical performance and clinical diagnostic accuracy of the SuperFlex point-of-care testing (POCT) High-Sensitivity Cardiac Troponin I (hs-cTnI) assay system.

Method: The imprecision, the limit of blank (LoB), the limit of detection (LoD), the limit of quantitation (LoQ), linearity, and comparability were assessed as per the Clinical and Laboratory Standards Institute guidelines. Also, the 99th-percentile reference value and diagnostic accuracy were evaluated.

Results: The reproducibility and total imprecision were 1.52–1.92% and 2.69–2.92%, respectively. LoB and LoD were 1ng/L and 1.8ng/L, respectively, and LoQ was 12ng/L at 10% coefficient of variation (CV). The results met the requirements of linearity, and the correlation coefficient was 0.996. The SuperFlex POCT results had good agreement with those obtained by the Siemens Advia 2400. The CV% was 7.24% at the 99th percentile concentration (p99th) of 25.6ng/L (95% confidence interval: 22.0–33.3ng/L) from 620 healthy populations. The sex-partitioned CV% and p99th were 7.15% at 27ng/L (males; n = 308) and 7.35% at 24ng/L (females; n = 312), respectively (p < 0.0001). The hs-cTnI detection rate of all observed healthy individuals from LoD to 99th was 82.57% by the SuperFlex POCT assay, 89.90% for the males, and 75.48% for the females. The sensitivity, specificity, positive predictive value, and negative predictive value of diagnostic performance for acute myocardial infarction were 100%, 81.25%, 57%, and 100%, respectively.

Conclusions: The SuperFlex POCT system showed the analytical performance characteristics required for enabling the clinical use of a hs-cTnI assay.

背景：我们旨在评估 SuperFlex 床旁检测 (POCT) 高灵敏度心脏肌钙蛋白 I (hs-cTnI) 检测系统的分析性能和临床诊断准确性。

方法：根据临床和实验室标准协会的指南评估不精密度、空白限 (LoB)、检测限 (LoD)、定量限 (LoQ)、线性和可比性。此外，还评估了第 99 个百分位的参考值和诊断准确性。

结果：重现性和总不精密度分别为 1.52-1.92% 和 2.69-2.92%。LoB 和 LoD 分别为 1ng/L 和 1.8ng/L，LoQ 为 12ng/L，变异系数 (CV) 为 10%。结果符合线性要求，相关系数为0.996。SuperFlex POCT 结果与西门子 Advia 2400 获得的结果非常一致。在 25.6 ng/L 的第 99 个百分位浓度 (p99th) 时，CV% 为 7.24%（95% 置信区间：22.0°33.3ng/ L) 来自 620 个健康人群。性别划分的 CV% 和 p99th 在 27 ng/L（男性；n = 308）和 24ng/L（女性；n = 312）时分别为 7.15% 和 7.35% (p?????<???? 0.0001）。通过 SuperFlex POCT 检测，从 LoD 到第 99 位观察到的所有健康个体的 hs-cTnI 检测率为 82.57%，男性为 89.90%，女性为 75.48%。

结论：SuperFlex POCT 系统显示了实现 hs-cTnI 检测临床应用所需的分析性能特征。