Policy analysis demonstrates inconsistencies in defining point-of-care diagnostics, highlighting challenges when adapting domestic regulatory standards to global health settings.
Although point-of-care (POC) testing is widely considered a good idea, there is little agreement on what exactly it entails. While regulatory agencies such as the U.S. Food and Drug Administration (FDA) categorize tests based on criteria such as complexity and Clinical Laboratory Improvement Amendments (CLIA) waivers, the choice of criteria becomes vastly more complex when moving from issues concerning national to global health diagnostics.
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Pai et al. (2015) studied this question.
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