Abstract
A scalable, generic wireless colour detector for point-of-care diagnostics in resource-limited settings is presented. The challenges faced in these settings have limited the effectiveness of point-of-care diagnostics. By combining the growing fields of paper-based diagnostics and printed electronics with Southern African clinic perspectives, a mass-producible, low-cost, paper-based solution for result readout and communication was developed. Printed radio frequency identification devices with sensing capabilities were manufactured, targeting colour detection from lateral flow test strip devices and other typical paper-based rapid test formats. The results were compared to those obtained from a commercial lateral flow test strip reader and image analysis using ImageJ, and demonstrate suitability for delivering automated readout and communication of results. The wireless colour detector is compatible with different test strip form factors, providing a modular solution and reducing the need for training. The solution is low cost and maintenance free, and thus fitting for resource-limited settings. A scalable version of the solution has been developed, making use of standard manufacturing processes for printing and packaging industries, initially using sheet-to-sheet formats, but with the goal of being scalable to roll-to-roll processes. This would enable the possibility of local manufacture, and mass distribution of the devices to those resource-limited areas where they are most needed, and where they will have the greatest impact on point-of-care testing.
Highlights
The unique challenges faced in these settings have been highlighted by the ASSURED criteria (Affordable, Sensitive, Specific, User friendly, Rapid and Robust, Equipment-free and Deliverable to end-users) as set out by the World Health Organization,[12] and more recently, the modified REASSURED criteria[13] to include newer technologies
Paperbased diagnostics, which include typical lateral flow test (LFT) formats such as pregnancy tests, as well as paper-based microfluidics,[14,15,16,17,18] are well suited to meeting many of the REASSURED aspects. This is evident from the success of simple yes/no rapid tests, where over 100 million malaria and HIV LFTs are performed every year per disease, with the majority carried out in resource-limited areas.[19]
Five clinics or community health centres were visited within Tshwane districts 1, 5, 6 and 7 in South Africa, and interviews were conducted with five professional nurses with an average work experience of 26 years each
Summary
The unique challenges faced in these settings have been highlighted by the ASSURED criteria (Affordable, Sensitive, Specific, User friendly, Rapid and Robust, Equipment-free and Deliverable to end-users) as set out by the World Health Organization,[12] and more recently, the modified REASSURED criteria[13] to include newer technologies. Paperbased diagnostics, which include typical lateral flow test (LFT) formats such as pregnancy tests, as well as paper-based microfluidics,[14,15,16,17,18] are well suited to meeting many of the REASSURED aspects. This is evident from the success of simple yes/no rapid tests, where over 100 million malaria and HIV LFTs are performed every year per disease, with the majority carried out in resource-limited areas.[19] there are large discrepancies in test performance between clinics and laboratories, largely due to user error.[20] As an example, for HIV tests carried out at twelve primary health care facilities in South Africa, more than 4% of tests resulted in false diagnoses,[20] leading to knock on effects in terms of spread of disease and stigma. The goal of this work is to provide a solution that automates result readout and capturing of results from these simple test formats to reduce these errors and align with important aspects of the REASSURED criteria
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