Jović Milica, Prim Denis, Righini Ophélie, Tagan David, Stäuble Mélanie, Pignat Marc, Gallay Steve, Geiser Martial, Pfeifer Marc E
Diagnostic Systems Research Group, Institute of Life Technologies, School of Engineering, University of Applied Sciences and Arts Western Switzerland (HES-SO Valais-Wallis) Rue de l'Industrie 19 1950 Sion Switzerland
Institute of Systems Engineering, School of Engineering, University of Applied Sciences and Arts Western Switzerland (HES-SO Valais-Wallis) Rue de l'Industrie 23 1950 Sion Switzerland.
Sens Diagn. 2023 May 30;2(4):964-975. doi: 10.1039/d3sd00090g. eCollection 2023 Jul 17.
Traumatic brain injuries (TBI) are typically acquired when a sudden violent event causes damage to the brain tissue. A high percentage (70-85%) of all TBI patients are suffering from mild TBI (mTBI), which is often difficult to detect and diagnose with standard imaging tools (MRI, CT scan) due to the absence of significant lesions and specific symptoms. Recent studies suggest that a screening test based on the measurement of a protein biomarker panel directly from a patient's blood can facilitate mTBI diagnosis. Herein, we report a novel prototype system designed as a precursor of a future hand-held point-of-care (POC) diagnostic device for the simultaneous multi-biomarker sensing, employing a microarray-type spatially resolved electrochemiluminescence immunoassay (SR-ECLIA). The small tabletop prototype consists of a screen-printed electrode compartment to conduct multi-analyte ECL sandwich assays, a potentiostat module and a light collection module, all integrated into a compact 3D-printed housing (18.2 × 16.5 × 5.0 cm), as well as an sCMOS detector. Based on this design concept, further miniaturization, system integration, performance optimization and clinical evaluation shall pave the way towards the development of a portable instrument for use at the site of accident and healthcare. To demonstrate the system's feasibility, current performance and efficiency, the simultaneous detection of three mTBI biomarkers (GFAP, h-FABP, S100β) in 50% serum was achieved in the upper pg mL range. The proposed device is amenable to the detection of other biomarker panels and thus could open new medical diagnostic avenues for sensitive multi-analyte measurements with low-volume biological sample requirements.
创伤性脑损伤（TBI）通常是在突然发生的暴力事件导致脑组织受损时获得的。所有TBI患者中有很高比例（70-85%）患有轻度TBI（mTBI），由于没有明显病变和特定症状，使用标准成像工具（MRI、CT扫描）往往难以检测和诊断。最近的研究表明，基于直接从患者血液中测量蛋白质生物标志物组的筛查测试可以促进mTBI的诊断。在此，我们报告了一种新型原型系统，该系统被设计为未来用于同时进行多生物标志物传感的手持式即时检测（POC）诊断设备的前身，采用微阵列型空间分辨电化学发光免疫分析（SR-ECLIA）。小型桌面原型由一个用于进行多分析物ECL夹心分析的丝网印刷电极室、一个恒电位仪模块和一个光收集模块组成，所有这些都集成在一个紧凑的3D打印外壳（18.2×16.5×5.0厘米）中，还有一个sCMOS探测器。基于这一设计理念，进一步的小型化、系统集成、性能优化和临床评估将为开发一种可在事故现场和医疗保健场所使用的便携式仪器铺平道路。为了证明该系统的可行性、当前性能和效率，在50%血清中实现了对上皮pg/mL范围内的三种mTBI生物标志物（GFAP、h-FABP、S100β）的同时检测。所提出的设备适用于检测其他生物标志物组，因此可以为低体积生物样本要求的灵敏多分析物测量开辟新的医学诊断途径。
