The Development Process of Point-of-Care Sensor-Based Detection Modules for Biomedical Diagnoses
摘要
The advancement of point-of-care (POC) diagnostics has brought a significant transformation in the field of biomedical diagnoses, hence requiring promptly available, precise, and easily accessible diagnostic instruments. The utilization of sensor-based detection modules is crucial in meeting these objectives. This chapter highlights various factors that are to be taken into account in the design, development, signal processing, problems, and applications related to sensor-based detection modules. Design considerations rely on several factors such as sensitivity, specificity, rapid response time, mobility, and integration of sample handling microfluidics systems. Other factors include the selection of materials and the chosen fabrication procedures. This chapter also describes the development process, which encompasses several key stages, including conceptualization, feasibility assessment, design iteration, optimization, and prototyping approaches. Strategies such as sample preparation, encapsulation, and adherence to Food and Drug Administration (FDA) rules and International Organization for Standardization (ISO) standards are employed to tackle challenges and constraints, including interference in biological samples, environmental conditions, and regulatory requirements.