Malaria is a major cause of morbidity and mortality world-wide.  This is especially true in low- and middle-income countries where inadequate healthcare infrastructure exists. With the growing rate of malaria transmission, there is still a disproportionate portion of the malaria-infected population that never even received any medical treatment. Successful management of malaria is hallmarked by rapid early-stage diagnosis, a high degree of accuracy, and a strong reporting and surveillance system. The increased incidence and burden of malaria has created a rapid need for better diagnostic techniques, a need to better track malaria transmission patterns [4] and improve local malaria epidemiology/surveillance.

Accurate measurement of Rapid Diagnostic Tests (RDTs) is essential for patient care and the control of the disease. Unfortunately, many challenges exist with RDTs including improperly conducting the test, misreading results, usage of expired or counterfeit tests and reagents, and the unavailability of a centralized information system to track real-time patients data.  The proposed study aims to evaluate the use and accuracy of an open standard RDT, which is a modified version of an existing WHO-approved malaria RDT that has embedded information on the cassette for identification and been optimized for smartphone image capture and use in laboratories in Indonesia for extraction of malaria DNA to do parasite strain typing to track the source of malaria transmission in a community.  Furthermore, a mobile application that called Open Reader RDT with in-process controls to mitigate user errors and seamless interoperability with frontline information systems will also be evaluated to facilitate real-time data analysis and population statistics and provide a foundation for computer vision and machine learning to enable accurate reading of diagnostic tests by mobile applications. Through the proposed study we aim to determine user experience and benefits to the frontline health worker, the accuracy of the open standard cassette, the mitigation of test and user errors, and the interoperability with frontline health systems. 

In collaboration with Ona, SID conducted Malaria RDT project in Manokwari started in November 2019. Supported by the Provincial Health Office of West Papua and District Health Office Manokwari, this study utilizes 15-20 health workers that will monitor malaria infection and illness occurring in their territory in Manokwari, West Papua.  There are separate sampling procedures depending on the location of sample collection which are the community, clinical setting, and community surveillance. Recently, we have tested more than 3000 people.

The study hypothesizes that modifications of the enhanced open standard RDT include modification to the cassette that improves image capture under adverse conditions, incorporation of color change features that prevent incorrect test adherence, and embedded data that allows for distinct identification of the cassette. The expectation is that the results will provide sufficient proof that an enhanced and open standard RDT cassette can improve use by mitigating associated errors. This enhanced open standard RDT with the associated application will provide a foundation to mitigate accidental or purposeful use of counterfeit or expired tests, usage of improper assay diluents, test adherence, and user reading error going forward.  Furthermore, the application will provide interoperability with front line health systems, such as OpenSRP, allowing a seamless interface to link and track RDT data as it relates to individual patients and populations. Providing this integration will allow trustworthy and accurate data for disease control. The enhanced open standard cassette will provide a set of guidelines and encourage RDT manufacturers to produce RDTs that can be captured and integrated onto this platform.