AI egg verification process.

<div><p>Background</p><p>Conventional microscopy of Kato-Katz (KK1.0) thick smears, the primary method for diagnosing soil-transmitted helminth (STH) infections, has limited sensitivity and is error-prone. Artificial intelligence-based digital pathology (AI-DP) may overcome the constraints of traditional microscopy-based diagnostics. This study in Ucayali, a remote Amazonian region of Peru, compares the performance of AI-DP-based Kato-Katz (KK2.0) method to KK1.0 at diagnosing STH infections in school-aged children (SAC).</p><p>Methods</p><p>In this prospective, non-interventional study, 510 stool samples from SAC (aged 5–14 years) were analyzed using KK1.0, KK2.0, and tube spontaneous sedimentation technique (TSET). KK1.0 and KK2.0 slides were evaluated at 30-minute and 24-hour timepoints for detection of <i>Ascaris lumbricoides</i>, <i>Trichuris trichiura</i>, and hookworms (at 30-minute only). Diagnostic performance was assessed by measuring STH eggs per gram of stool (EPG), sensitivity of methods, and agreement between the methods.</p><p>Results</p><p>KK2.0 detected more <i>A</i>. <i>lumbricoides</i> positive samples than KK1.0, with detection rates for <i>T</i>. <i>trichiura</i> and hookworms being comparable. At 30-minutes, 37.6%, 23.0%, and 2.6% of the samples tested positive based on KK1.0 for <i>A</i>. <i>lumbricoides</i>, <i>T</i>. <i>trichiura</i>, and hookworms, while this was 49.8%, 24.4%, and 1.9% for KK2.0. At 24-hours, 37.1% and 27.1% of the samples tested positive based on KK1.0 for <i>A</i>. <i>lumbricoides</i> and <i>T</i>. <i>trichiura</i>, while this was 45.8% and 24.1% for KK2.0. Mean EPG between KK2.0 and KK1.0 were not statistically different across STH species and timepoints, except for <i>T</i>. <i>trichiura</i> at 24-hours (higher mean EPG for KK1.0, <i>p</i> = 0.036). When considering infection intensity levels, KK2.0 identified 10% more of the total population as low-infection intensity samples of <i>A</i>. <i>lumbricoides</i> than KK1.0 (<i>p ≤</i> 0.001, both timepoints) and similar to KK1.0 for <i>T</i>. <i>trichiura</i> and hookworms. Varying agreement existed between KK1.0 and KK2.0 in detecting STH eggs (<i>A</i>. <i>lumbricoides</i>: moderate; <i>T</i>. <i>trichiura</i>: substantial; hookworms: slight). However, these findings should be interpreted carefully as there are certain limitations that may have impacted the results of this study.</p><p>Conclusions</p><p>This study demonstrates the potential of the AI-DP-based method for STH diagnosis. While similar to KK1.0, the AI-DP-based method outperforms it in certain aspects. These findings underscore the potential of advancing the AI-DP KK2.0 prototype for dependable STH diagnosis and furthering the development of automated digital microscopes in accordance with WHO guidelines for STH diagnosis.</p></div>