Abstract

Rapid diagnostic tests (RDTs) provide point-of-care medical screening without the need for expensive laboratory equipment. RDTs are theoretically straightforward to use, yet their analog colorimetric output leaves room for diagnostic uncertainty and error. Furthermore, RDT results within a community are kept isolated unless they are aggregated by healthcare workers, limiting the potential that RDTs can have in supporting public health efforts. In light of these issues, we present a system called RDTScan for detecting and interpreting lateral flow RDTs with a smartphone. RDTScan provides real-time guidance for clear RDT image capture and automatic interpretation for accurate diagnostic decisions. RDTScan is structured to be quickly configurable to new RDT designs by requiring only a template image and some metadata about how the RDT is supposed to be read, making it easier to extend than a data-driven approach. Through a controlled lab study, we demonstrate that RDTScan's limit-of-detection can match, and even exceed, the performance of expert readers who are interpreting the physical RDTs themselves. We then present two field evaluations of smartphone apps built on the RDTScan system: (1) at-home influenza testing in Australia and (2) malaria testing by community healthcare workers in Kenya. RDTScan achieved 97.5% and 96.3% accuracy compared to RDT interpretation by experts in the Australia Flu Study and the Kenya Malaria Study, respectively.

Highlights

  • Over the past couple of decades, rapid diagnostic test (RDTs) have emerged as a potential solution to the pressing need for accessible medical testing

  • The community health workers (CHWs) were asked to record their interpretation of the physical RDT (DIRECT_READ), which was later compared to the results of RDTScan (ALGO_READ) and whole blood samples that were later processed through reverse transcription quantitative polymerase chain reaction (RT-qPCR) (PCR_RESULT)

  • Due to mismatches between RDTs that were successfully captured using RDTScan and samples that could be processed by RT-qPCR, 228 images were used for comparison between ALGO_READ and PCR_RESULT

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Summary

Introduction

Over the past couple of decades, rapid diagnostic test (RDTs) have emerged as a potential solution to the pressing need for accessible medical testing. RDTs enable point-of-care diagnostics without the need for expensive equipment. RDTs are being developed to support convenient COVID-19 testing during the pandemic. RDTs are viable to produce at scale, making them an inexpensive (∼$1 USD each) alternative to laboratory tests and ideal for point-of-care medical screening [32, 53]. RDTs are often associated with community healthcare settings in lowand middle-income countries where resources and access to sophisticated testing facilities are limited, but RDTs are used worldwide in clinics and homes as well [5, 44]

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