Evaluation of AiDx Assist device for automated detection of Schistosoma eggs in stool and urine samples in Nigeria

Brice Meulah ¹ Pytsje Hoekstra ¹ Samuel Popoola ² Satyajith Jujjavarapu ² Moses Aderogba ³ Joseph O Fadare ⁴ John A Omotayo ⁴ DAVID BELL ⁵ Cornelis Hendrik Hokke ¹ Lisette Van Lieshout ¹ Gleb Vdovine ⁶ Jan Carel Diehl ^7* Temitope Agbana ² Louise Makau-Barasa ³ Jacob Solomon ⁸

• ¹ Leiden University Center for Infectious Diseases, Leiden University Medical Center (LUMC), Leiden, Netherlands
• ² AiDx Medical BV, Pijnacker, Netherlands
• ³ The Ending Neglected Diseases (END) Fund, New York, United States
• ⁴ College of Medicine, Ekiti State University, Ado-Ekiti, Ekiti, Nigeria
• ⁵ Other, Texas, United States
• ⁶ Delft Center for Systems and Control, Faculty of Mechanical, Maritime and Materials Engineering, Delft University of Technology, Delft, Netherlands
• ⁷ Department of Sustainable Design Engineering, Faculty of Industrial Design Engineering, Delft University of Technology, Delft, Netherlands
• ⁸ NTD Division, Federal Ministry of Health, Abuja, Nigeria

Schistosomiasis is a public health concern and there is need for reliable, field compatible diagnostic methods in endemic settings. The AiDx Assist, an artificial intelligence (AI)-based automated microscope, has shown promising results for the detection of Schistosoma haematobium eggs in urine. It has been further developed for the detection of Schistosoma mansoni eggs in stool. In this study, we evaluated the performance of the AiDx Assist for the detection of S. mansoni eggs in stool as well as further validating the performance of the AiDx Assist for the detection of S. haematobium eggs in urine. Additionally, the potential of AiDx Assist for the detection of other helminths in stool was explored.In total, 405 participants from an area endemic for both S. mansoni and S. haematobium provided stool and urine samples which were subjected to AiDx Assist (semi-and fullyautomated), while conventional microscopy was used as the diagnostic reference. Only samples with complete test results were included in the final analysis, resulting in 375 stool and 398 urine, of which 38.4% and 65.3% showed Schistosoma eggs by conventional microscopy. The collected images of stool samples were retrospectively examined for other helminth eggs via manual analysis.For the detection of S. mansoni eggs, the sensitivity of the semi-automated AiDx Assist (86.8%) was significantly higher compared to the fully-automated AiDx Assist (56.9%) while the specificity was comparable, being 81.4% and 86.8%, respectively. Retrospectively, eggs of Ascaris lumbricoides and Trichuris trichiura were visualized. For the examination of urine samples, a comparable sensitivity in the detection of S. haematobium eggs was seen between the semi-and the fully automated mode of the AiDx Assist, showing 94.6% and 91.9%, respectively. Also the specificity was comparable, with 90.6% and 91.3% respectively.The AiDx Assist meets the World Health Organization Target Product Profile criteria in terms of diagnostic accuracy for the detection of S. haematobium eggs in urine, while performing modestly for the detection of S. mansoni eggs in stool. With some further improvements, it has the potential to become a valuable diagnostic tool for screening multiple helminth parasites in stool and urine.