Developing a Multiplexed 3D-Printed Prototype Point-of-Care Testing Device for HIV and Hepatitis C in High-Risk Populations

Abstract

The manufacture of point-of-care testing devices for key diseases such as HIV and Hepatitis C remains neglected in sub-Saharan Africa despite the critical need for the point-of-care devices. This research project provides initial steps in the development of a lateral flow immunoassay-based multiplexed point-of-care device (HIV/HCV multiplexed point-of-care device) that can detect co-occurrence of HIV and the hepatitis C virus. Additionally, the project provides insights on the perspectives of healthcare professionals on multiplexed point-of-care devices. The study further reports on the market analysis of the point-of-care devices industry, assessing the market size, the customer segments, competition, and barriers to market entry. Data for understanding the healthcare professionals’ perspectives on multiplexed point-of-care was collected through a survey with 21 Bambanani Newstart Centre healthcare professionals. The market analysis was conducted using secondary data, and laboratory experiments were utilised in the development of the HIV/HCV multiplexed point-of-care device. Findings from the survey and the market analysis, along with a laboratory protocol manual guided the development of the HIV/HCV multiplexed point-of-care device. The study found that healthcare professionals at Bambanani Newstart Centre have an unmet need for multiplexed point-of-care devices. The respondents highlighted that multiplexed point-of-care devices improve patient management; ensure targeted treatment; offer a cheaper diagnostic option; ensure diagnostic certainty; save time for diagnosis and reduce the need to refer a patient to the laboratory. The respondents cited the shortage of multiplexed point-of-care devices as the biggest challenge in their routine work. The market analysis reviewed that multiplexed point-of-care devices have a ready market in sub-Saharan Africa. The global point-of-care device industry is expected to grow at a compound annual growth rate of 11.1% to reach US$93.2 billion by 2030, with Africa providing the largest market for infectious diseases testing devices. There is however a limited supply of HIV/HCV multiplexed point-of-care devices in sub-Saharan Africa. The available multiplexed point-of-care devices are manufactured outside the African region, mainly in the United States of America, Europe and China. The market analysis cited competition from imported point-of-care devices as a major barrier. Access to distribution channels is another barriers the HIV/HCV multiplexed point-of-care device may face. Despite the development of the HIV/HCV multiplexed point-of-care device for this project being still in progress, the mode of multiplexing, and the capture and detection antibody concentrations have been determined. The device is composed of multiple strips supplied by a single sample stream. The antibody concentration of 0.5 μg/ml was selected for HIV capture antibody, Hepatitis C capture antibody and Hepatitis C detection antibody. The concentration of 1 μg/ml was selected for HIV detection antibody. The researcher however recommends further research with a larger sample size to understand the perspectives of healthcare professionals. Additionally, collaboration among industry partners and healthcare professionals is essential in order to promote local innovation.