Policy analysis: User monitoring of <i>in-vitro</i> diagnostic medical devices used for near-patient testing of infectious diseases

Abstract Background All individuals should have equitable access to accurate and timely testing for infectious diseases, which underpins diagnosis treatment, safeguards blood supplies, is used determine disease prevalence. Disadvantaged populations limited laboratory-based testing, so near-patient or point-of-care (PoCT) has been developed implemented. Unlike PoCT often performed by non-laboratory staff outside regulatory frameworks. Quality assurance (QA) of lacking inappropriate, meaning inaccurate can go undetected, leading poor patient outcomes. Objective To review the application QA use detect diseases propose fit-for-purpose alternatives. Method A current was undertaken experienced providers mapping points failure. Barriers providing include inappropriate unstable sample types; expensive shipping remote sites, including dry ice shipment; cost international programmes; costs; fixed test events; a lack technology simple, centralized data collection facilitating rapid analysis reporting results. Based on these findings, novel, model described. Results The new identifies describes novel types, tube samples, dried swabs, liquid-stable clinical samples that are inactivated stable at ambient temperature; modified distribution channels; method using mobile phone technology. Conclusion findings this paper seek describe process, aims improve quality PoCT, globally.