For many parasitic diseases, the microscopic examination of clinical samples such as urine and stool still serves as the diagnostic reference standard, primarily because microscopes are accessible and cost-effective. However, conventional microscopy is laborious, requires highly skilled personnel, and is highly subjective. Requirements for skilled operators, coupled with the cost and maintenance needs of the microscopes, which is hardly done in endemic countries, presents grossly limited access to the diagnosis of parasitic diseases in resource-limited settings. The urgent requirement for the management of tropical diseases such as schistosomiasis, which is now focused on elimination, has underscored the critical need for the creation of access to easy-to-use diagnosis for case detection, community mapping, and surveillance. In this paper, we present a low-cost automated digital microscope—the Schistoscope—which is capable of automatic focusing and scanning regions of interest in prepared microscope slides, and automatic detection of Schistosoma haematobium eggs in captured images. The device was developed using widely accessible distributed manufacturing methods and off-the-shelf components to enable local manufacturability and ease of maintenance. For proof of principle, we created a Schistosoma haematobium egg dataset of over 5000 images captured from spiked and clinical urine samples from field settings and demonstrated the automatic detection of Schistosoma haematobium eggs using a trained deep neural network model. The experiments and results presented in this paper collectively illustrate the robustness, stability, and optical performance of the device, making it suitable for use in the monitoring and evaluation of schistosomiasis control programs in endemic settings. @en

Conventional microscopy is the standard procedure for the diagnosis of schistosomiasis, despite its limited sensitivity, reliance on skilled personnel, and the fact that it is error prone. Here, we report the performance of the innovative (semi-)automated Schistoscope 5.0 for optical digital detection and quantification of Schistosoma haematobium eggs in urine, using conventional microscopy as the reference standard. At baseline, 487 participants in a rural setting in Nigeria were assessed, of which 166 (34.1%) tested S. haematobium positive by conventional microscopy. Captured images from the Schistoscope 5.0 were analyzed manually (semiautomation) and by an artificial intelligence (AI) algorithm (full automation). Semi- and fully automated digital microscopy showed comparable sensitivities of 80.1% (95% confidence interval [CI]: 73.2-86.0) and 87.3% (95%CI: 81.3-92.0), but a significant difference in specificity of 95.3% (95% CI: 92.4-97.4) and 48.9% (95% CI: 43.3-55.0), respectively. Overall, estimated egg counts of semi- and fully automated digital microscopy correlated significantly with the egg counts of conventional microscopy (r50.90 and r50.80, respectively, P < 0.001), although the fully automated procedure generally underestimated the higher egg counts. In 38 egg positive cases, an additional urine sample was examined 10 days after praziquantel treatment, showing a similar cure rate and egg reduction rate when comparing conventional microscopy with semiautomated digital microscopy. In this first extensive field evaluation, we found the semiautomated Schistoscope 5.0 to be a promising tool for the detection and monitoring of S. haematobium infection, although further improvement of the AI algorithm for full automation is required.

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Schistosomiasis is a neglected tropical disease thatis predominantly diagnosed by conventional microscopy in Sub-Saharan Africa. However, effective diagnosis by conventional microscopy is limited by multiple technical and logistic barriers.Alternative diagnostic techniques are needed. The Schistoscope is a digital optical device that has been designed to support microscopists for the detection of schistosomiasis in endemic resource-limited settings. Aim: A user-centered design approachwas used to assess the usability and user-acceptance of the Schistoscope compared to conventional microscopy in the Federal Capital Territory, Abuja, Nigeria. In this study, usability and acceptance are defined as being easy-to-use, efficient, and suitable in the daily workflow by end-users. Methods: Using a qualitative conventional context analysis approach, a mixedmethods questionnaire was used to elucidate themes related to the usability and user-acceptance of the device. Participants included trained microscopists and university students (n=17). Results: Participants answered both ranked and open questions. Overall the device’s use was considered to be easy and acceptable
in the routine workflow of a microscopist. The auto-scan feature was considered to have added value. Critical feedback regarding aesthetics of the device, particularly related to size, was noted by the participants. Conclusion: The usability approach used in this study elucidated valuable insights of end-users. The Schistoscope was very well perceived by both medical students and trained microscopists. Critical feedback will be used to further improve the next iterative design of the device.@en

Schistosomiasis is a neglected tropical disease of Public Health importance affecting over 252 million people worldwide with Nigeria having a very high number of cases. It is caused by blood flukes of the genus Schistosoma and transmitted by freshwater snails. To achieve the current global elimination objectives, low-cost and easy-to-use diagnostic tools are critically needed. Recent innovations in optical and computer technologies have made handheld digital and smartphone-based microscopes a viable diagnostic approach. Development, validation and deployment of these diagnostic devices for field use, however, require the optimisation of its optical train for the registration of high-resolution images and the realisation of a robust system design that can be locally produced in lowincome countries. Field research conducted in Nigeria with active involvement of key stakeholders in research and development (R&D) led to the design of an initial prototype device for the diagnosis of urinary schistosomiasis, called Schistoscope 1.0. In this paper, we present further development of the Schistoscope 1.0 along two parallel design trajectories: a Raspberry Pi and a Smartphone-based Schistoscope. Specifically, we focused on the optimization of the optics, embodiment design and the electronics systems of the devices so as to produce a robust design with potential for local production.@en

Schistosomiasis is a treatable and preventable neglected tropical disease of Public Health importance affecting over 250 million people worldwide while Nigeria is one of the high burden countries. Currently available diagnoses are cumbersome, low in sensitivity and not field-adaptable given the high skill required that are not available in the rural settings where the diseases are majorly prevalent. Democratizing access to diagnosis with a rapid, easy-to-use, accurate diagnosis is critical in currently stepped-up control, pre-elimination and elimination strategies for urinary schistosomiasis. In this paper, we describe the design process of a low-cost smartphone-based microscope for rapid diagnosis of urinary Schistosomiasis. Field research conducted in Nigeria with the active involvement of key stakeholders in the research and development (R&D) process validated our assumptions and enabled the development of our proof-of-concept into a working prototype in three iterative designs steps. Through this design process, we investigated the local development of technical optics for good quality imaging and explored the simplification of sample preparation techniques using commonly available materials. Starting from the first iteration, the output of each design step was used as the input to the subsequent iterations to optimize our system design. Insightful results and input from the field demonstrated that an adaptive design approach was needed to facilitate the rapid development and deployment of point-of-care diagnostic devices for use in low-resource settings. It is our goal that these devices will be locally manufactured in Nigeria to expand access to the test given her huge population and high disease burden, quick repairs,and easy maintenance on the field.@en