Medical Devices: Capabilities and challenges of technologies to enable rapid diagnoses of infectious diseases
Commercially available multiplex point-of-care technologies (MPOCTs) have a range of performance characteristics that describe, among other things, the ability of the technology to correctly identify the presence or absence of a pathogen. Some of these characteristics are used by the FDA to evaluate the technologies prior to approval; other attributes are considered by developers in designing and marketing their technologies. Technologies GAO examined have varying features such as physical size, number of diseases being tested for at the same time, and throughput – or the number of patient samples that can be simultaneously run. The amount of time it took for the technologies to return results to users ranged from 20 minutes to 2 hours. Among available technologies offered by the eight developers that GAO visited, procurement costs ranged from $25,000 to $530,000, and per-test operational costs ranged from $20 to $200.
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Medical Devices
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Science, Technology Assessment, and Analytics team of the U.S. Government Accountability Office (GAO) (STAA)
United States of America