Heart disease is growing annually across the globe with numbers expected to rise to 46% of the population by 2030. Early detection is vital for several reasons, firstly it improves the long-term prognosis of the patient by admitting them through the appropriate pathway faster, secondly it reduces healthcare costs by streamlining diagnosis and finally, in combination with management or treatment, it can prevent the progression of the disease which in turn improves the patient’s quality of life. Therefore, there lies an increasing need to develop assays which can rapidly detect heart disease at an early stage. The Dxcover® liquid biopsy platform employs infrared spectroscopy and artificial intelligence, to quickly analyse minute amounts of patient serum. In this study, discrimination between healthy controls and diseased patients was obtained with an area under the receiver operating characteristic curve (AUC) of 0.89. When assessing the heart failure vs all patients, which is most akin to what would be observed in a triage setting, the model when tuned to a minimum of 45% specificity yielded a sensitivity of 89% and an NPV of 0.996, conversely when sensitivity was set at a 45% minimum, the specificity was 96%, giving an NPV of 0.991 when using a 1.5% prevalence. Other models were assessed in parallel, but the performance of the ORFPLS model was overall superior to the other models tested. In this large scale (n = 404) proof-of-concept study, we have shown that the Dxcover liquid biopsy platform has the potential to be a viable triage tool in emergency and routine situations for the diagnosis of heart failure.

心脏病在全球范围内每年都在增长，预计到 2030 年，患病人数将上升到人口的 46%。早期检测至关重要，原因有几个，首先，它可以通过更快地通过适当的途径让患者入院，从而改善患者的长期预后，其次，它通过简化诊断来降低医疗成本，最后，结合管理或治疗，它可以防止疾病的进展，从而提高患者的生活质量。因此，越来越需要开发能够在早期快速检测心脏病的测定方法。Dxcover®液体活检平台采用红外光谱和人工智能，快速分析微量患者血清。在这项研究中，健康对照者和患病患者之间的区分是通过受试者工作特征曲线下面积 (AUC) 为 0.89 获得的。当评估所有患者的心力衰竭时（最类似于在分诊环境中观察到的情况），当将模型调整到最低 45% 特异性时，其灵敏度为 89%，NPV 为 0.996，反之，当灵敏度为如果将最小值设置为 45%，则特异性为 96%，当使用 1.5% 的患病率时，NPV 为 0.991。并行评估其他模型，但 ORFPLS 模型的性能总体优于其他测试模型。在这项大规模 (n = 404) 概念验证研究中，我们证明 Dxcover 液体活检平台有潜力成为紧急和常规情况下诊断心力衰竭的可行分诊工具。