Malaria is a major cause of morbidity and mortality worldwide. This is especially the case in low- and middle-income countries where adequate health infrastructure does not exist. With increasing rates of malaria transmission, there is still a disproportionate share of the malaria-infected population that never even receives medical treatment. Successful management of malaria is characterized by rapid early-stage diagnosis, high levels of accuracy, and strong monitoring and reporting systems. The increasing incidence and burden of malaria has created an urgent need for better diagnostic techniques, a need to better track patterns of malaria transmission, and improve local malaria epidemiology or surveillance.
Accurate measurement of Rapid Diagnostic Tests (RDTs) is essential for patient care and disease control. Unfortunately, there are many challenges to the use of RDTs including errors in administering the test, errors in reading the results, use of counterfeit or expired tests and reagents and the unavailability of a centralized information system to track patient data in a timely manner. The proposed study aims to evaluate the use and accuracy of the open standard RDT, which is a modified version of the WHO-approved malaria RDT. This version has embedded information on a cassette to identify and has been optimized for image capture using a smartphone and is used in laboratories in Indonesia to extract malaria DNA for typing parasite strains to trace sources of malaria transmission in a community. In addition, a mobile application called Open Reader RDT with process control reduces user errors and seamless interoperability. Frontline information systems will also be evaluated to facilitate real-time data analysis, population statistics, provide a foundation for computer vision and machine learning to enable accurate diagnostic test readings by mobile applications. Through the proposed research we aim to determine user experience and benefits to frontline healthcare workers, accuracy of open standard cassettes, mitigation of testing and user errors and interoperability with frontline healthcare systems.
In collaboration with Ona, SID carried out the RDT Malaria project in Manokwari starting in November 2019. Supported by the West Papua Provincial Health Office and the Manokwari District Health Office, this study involved 15-20 health workers who would monitor malaria infections and other diseases occurring in their area in Manokwari, West Papua. There are two separate sampling procedures depending on the sampling location namely community, clinical setting and community surveillance. Recently, we have tested more than 3000 people.
This study hypothesizes that improved open standard RDT modifications include modifications to the cassette that improve shooting under adverse conditions, incorporation of a color shift feature that prevents improper test compliance and embedded data that allows identification of distinct cassettes. The hope is that the results will provide sufficient evidence that an improved, open standard RDT cassette can increase usage by reducing the error. These enhanced RDTs with associated applications will provide a foundation for mitigating the intentional or unintentional use of counterfeit or outdated tests, inappropriate use of test diluents, test compliance and user misreading in the future. Additionally, these applications will provide interoperability with frontline healthcare systems, such as OpenSRP, enabling a seamless interface to link and track RDT data related to individual patients and populations. Providing this integration will enable accurate and reliable 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 into this platform.