Wu Feng, Xu Yili, Ji Chenyang, Li Xue, Shen Jue, Fei Yejie, Yuan Guanghan, Qian Hui
Jiangsu Key Laboratory of Medical Science and Laboratory Medicine, Department of Laboratory Medicine, School of Medicine, Jiangsu University, 301 Xuefu Road, Zhenjiang, 212013, Jiangsu Province, China.
Anal Chim Acta. 2025 May 8;1350:343876. doi: 10.1016/j.aca.2025.343876. Epub 2025 Feb 26.
The coagulation process is inherently complex, and conventional diagnostic techniques are typically only capable of detecting single coagulation factors, lacking capacity to assess the overall coagulation function of the patient. Therefore, it is thus imperative to develop a novel, global coagulation assay for the diagnosis of hemorrhagic and thrombotic disorders and to evaluate the therapeutic efficacy of anticoagulant drugs. The ordered porous layer interferometry technology, developed using silica colloidal crystal (SCC) film as sensing substrate, is characterized by low cost, real-time, and convenient operation. Furthermore, entire biological events process can be detected by migration of the SCC film interference spectra.
In this study, we developed a global coagulation assay with ordered porous layer interferometry by SCC film, a model of coagulation was created using fibrinogen and thrombin. The results demonstrated that this method could analyze the effect of different thrombin activities and different fibrinogen concentrations on the coagulation process. The performance of the coagulation assay was further validated using real blood samples and the method was found to have excellent detection capacity for different concentrations of CaCl, which could trigger coagulation process. Hypercoagulable and hypocoagulable samples were tested by setting different biochemical conditions, and it could distinguish blood samples from different states significantly. Clinical samples were collected and the approach was compared with standard coagulation assays with satisfactory clinical correlation.
This global coagulation assay is simple, rapid and real-time, and does not require various biochemical reagents. The whole process of coagulation reaction can be recorded, and multiple coagulation indicators can be obtained in one test. It is anticipated to provide a novel low-cost and powerful method for clinical coagulation testing.
凝血过程本质上很复杂，传统诊断技术通常只能检测单个凝血因子，缺乏评估患者整体凝血功能的能力。因此，开发一种用于诊断出血性和血栓性疾病以及评估抗凝药物治疗效果的新型全局凝血检测方法势在必行。以二氧化硅胶体晶体（SCC）膜为传感基质开发的有序多孔层干涉测量技术，具有成本低、实时和操作方便的特点。此外，通过SCC膜干涉光谱的迁移可以检测整个生物事件过程。
在本研究中，我们利用SCC膜通过有序多孔层干涉测量法开发了一种全局凝血检测方法，使用纤维蛋白原和凝血酶创建了凝血模型。结果表明，该方法可以分析不同凝血酶活性和不同纤维蛋白原浓度对凝血过程的影响。使用实际血液样本进一步验证了凝血检测方法的性能，发现该方法对不同浓度的氯化钙具有出色的检测能力，氯化钙可触发凝血过程。通过设置不同的生化条件对高凝和低凝样本进行测试，它可以显著区分不同状态的血液样本。收集了临床样本，并将该方法与标准凝血检测方法进行了比较，临床相关性良好。
这种全局凝血检测方法简单、快速且实时，不需要各种生化试剂。可以记录凝血反应的全过程，一次测试可获得多个凝血指标。预计可为临床凝血检测提供一种新型的低成本且强大的方法。
