Keywords: point of care, detection, in vitro diagnostics, infectious disease
Summary:In Vitro Diagnostic (IVD) devices encompass a broad range of tests that include infectious diseases and have been used to detect and diagnose pathogens for decades. Recent outbreaks such as Monkeypox and the Sudan Ebola Virus have led to greater need for IVDs that bring the point of care out of the clinical setting and directly to the user, as exemplified by the demand from the COVID-19 pandemic. These Point of Care (POC) devices are ideally portable, functional in low resource environments, easily interpreted, and have limited logistical or storage requirements from manufacturer-to-user. However, this high bar for functionality is supported by novel bioengineering and assay chemistry developments. The rapidly expanding market for infectious disease POC IVDs highlights the need for an effective product development approach that considers a wide scope of forward leaning considerations to include characteristics of a POC device, detection technology, and market assessments. Together, these key factors underscore the need for a clearly defined path from conceptualization to market launch. In this review, we outline how Infectious Disease IVD development has evolved while highlighting POC device-specific considerations.