Real-time global coagulation assay via ordered porous layer interferometry using silica colloidal crystal film

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 CaCl₂, 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.