Fig 3 -

Correlation between S. haematobium egg counts measured by the Schistoscope and S. haematobium egg counts measured by conventional microscopy (a, d, e), Ct-values determined by real-time PCR (b, f) and urine CAA concentration measured by UCP-LF CAA (c, g) in study A and B.</p

S1 Raw Dataset -

Overall raw dataset containing data for Schistoscope validation on fresh urine samples (study A), Banked slides (study B) and quality control of banked slides. (XLSX)</p

S1 Fig -

Agreement between the Schistoscope and microscopy per category of infection intensity in study A and B. (TIF)</p

Fig 2 -

(a) Five Schistoscopes connected to a single display and in use for slide analysis by a laboratory technician. (b) Schistoscope display of result window after slide analysis is completed. (c) Schistoscope image showing some of the overlapping eggs counted as a single egg by the AI algorithm.</p

Video showing the Schistoscopes running in the laboratory.

Video showing the Schistoscopes running in the laboratory.</p

Image showing crystal incorrectly detected as an egg by the Schistoscope.

Image showing crystal incorrectly detected as an egg by the Schistoscope.</p

STARD-2015-Checklist.

IntroductionSchistosomiasis 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).MethodsBased 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.ResultsIn 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).ConclusionOverall, 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.Trial registrationNCT04505046 ClinicalTrials.gov.</div

Diagnostic performance and pairwise level of agreement by Cohen’s Kappa statistics between the Schistoscope and conventional microscopy and the composite reference for the detection of <i>S</i>. <i>haematobium</i> infection in study A and B.

Diagnostic performance and pairwise level of agreement by Cohen’s Kappa statistics between the Schistoscope and conventional microscopy and the composite reference for the detection of S. haematobium infection in study A and B.</p

Comprehensive flow chart detailing the methodical sequence of urine sample collection, processing by the Schistoscope, conventional microscopy, real-time PCR and UCP-LF CAA and data analysis.

Comprehensive flow chart detailing the methodical sequence of urine sample collection, processing by the Schistoscope, conventional microscopy, real-time PCR and UCP-LF CAA and data analysis.</p

Diagnostic outcomes of the Schistoscope in comparison to conventional microscopy, real-time PCR and UCP-LF CAA in study A and B.

Diagnostic outcomes of the Schistoscope in comparison to conventional microscopy, real-time PCR and UCP-LF CAA in study A and B.</p