03407nas a2200337   4500000000100000008004100001260003700042653002400079653005700103100001300160700001200173700001600185700001400201700001400215700002300229700001900252700001500271700001200286700001900298700001300317700001300330700001600343700001900359700001400378245014100392856009900533300000900632490000700641520240700648022001403055       2024                            d  bPublic Library of Science (PLoS)10aInfectious Diseases10aPublic Health, Environmental and Occupational Health1 aMeulah B1 aOyibo P1 aHoekstra PT1 aMoure PAN1 aMaloum MN1 aLaclong-Lontchi RA1 aHonkpehedji YJ1 aBengtson M1 aHokke C1 aCorstjens PLAM1 aAgbana T1 aDiehl JC1 aAdegnika AA1 aVan Lieshout L1 aRinaldi G00aValidation of artificial intelligence-based digital microscopy for automated detection of Schistosoma haematobium eggs in urine in Gabon  uhttps://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0011967&type=printable  a1-160 v183 a<p><strong>Introduction:</strong> 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).</p>

<p><strong>Methods:</strong> 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.</p>

<p><strong>Results:</strong> 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).</p>

<p><strong>Conclusion:</strong> 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. Trial registration NCT04505046 ClinicalTrials.gov.</p>
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