Introduction: Schistosomiasis is a public health concern and there is a 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 to detect Schistosoma mansoni eggs in stool.

Methods: In this study, we evaluated the performance of the AiDx Assist for the detection of S. mansoni eggs in stool samples and further validated the performance of the AiDx Assist for the detection of S. haematobium eggs in urine samples. Additionally, the potential of the AiDx Assist for the detection of other helminths in stool samples 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 fully automated), while conventional microscopy was used as the diagnostic reference.

Results: Only samples with complete test results were included in the final analysis, resulting in 375 stool and 398 urine samples, of which 38.4% and 65.3% showed Schistosoma eggs by conventional microscopy. The collected images of the 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, with 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 found between the semi-and the fully automated modes of the AiDx Assist, showing 94.6% and 91.9%, respectively. Furthermore, the specificity was comparable, with 90.6%and 91.3% respectively.

Discussion: The AiDx Assist met the World Health Organization Target Product Profile criteria in terms of diagnostic accuracy for the detection of S. haematobium eggs in urine samples and performed modestly in the detection of S. mansoni eggs in stool samples. With some further improvements, it has the potential to become a valuable diagnostic tool for screening multiple helminth parasites in stool and urine samples.@en

Introduction
Schistosomiasis is a significant public health concern, especially in Sub-Saharan Africa. Conventional microscopy is the standard diagnostic method in resource-limited settings, but with limitations, such as the need for expert microscopists. An automated digital microscope with artificial intelligence (Schistoscope), offers a potential solution. This field study aimed to validate the diagnostic performance of the Schistoscope for detecting and quantifying Schistosoma haematobium eggs in urine compared to conventional microscopy and to a composite reference standard (CRS) consisting of real-time PCR and the up-converting particle (UCP) lateral flow (LF) test for the detection of schistosome circulating anodic antigen (CAA).

Methods
Based on a non-inferiority concept, the Schistoscope was evaluated in two parts: study A, consisting of 339 freshly collected urine samples and study B, consisting of 798 fresh urine samples that were also banked as slides for analysis with the Schistoscope. In both studies, the Schistoscope, conventional microscopy, real-time PCR and UCP-LF CAA were performed and samples with all the diagnostic test results were included in the analysis. All diagnostic procedures were performed in a laboratory located in a rural area of Gabon, endemic for S. haematobium.

Results
In study A and B, the Schistoscope demonstrated a sensitivity of 83.1% and 96.3% compared to conventional microscopy, and 62.9% and 78.0% compared to the CRS. The sensitivity of conventional microscopy in study A and B compared to the CRS was 61.9% and 75.2%, respectively, comparable to the Schistoscope. The specificity of the Schistoscope in study A (78.8%) was significantly lower than that of conventional microscopy (96.4%) based on the CRS but comparable in study B (90.9% and 98.0%, respectively).

Conclusion
Overall, the performance of the Schistoscope was non-inferior to conventional microscopy with a comparable sensitivity, although the specificity varied. The Schistoscope shows promising diagnostic accuracy, particularly for samples with moderate to higher infection intensities as well as for banked sample slides, highlighting the potential for retrospective analysis in resource-limited settings.@en