Evaluation of a Schisto -LAMP assay for the molecular diagnosis of schistosomiasis: a proof-of-principle comparative study with qPCR and Kato-Katz

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Abstract Schistosomiasis remains a major public health concern in Madagascar, where access to sensitive and user-friendly diagnostic tools is essential for effective control. This study evaluated the diagnostic performance of the Schisto -LAMP assay for detecting Schistosoma spp. in stool samples from schoolchildren in a rural area of central Madagascar, comparing it with Kato-Katz and a commercial qPCR assay. A total of 102 children aged 5–15 years from Soavinarivo participated. Stool samples were analysed using Kato-Katz, qPCR and Schisto -LAMP. All molecular analyses were performed in a well-equipped laboratory in Spain. Agreement between methods was assessed using the Kappa coefficient and McNemar’s test, and diagnostic accuracy was calculated using a composite reference standard. Molecular methods detected the highest prevalence of infection. Agreement between Kato-Katz and molecular methods was low (Kappa = 0.259 for qPCR; 0.347 for Schisto -LAMP). Moderate-intensity infections were most frequent (23/40), all detected by qPCR (median Ct: 26) and 20/23 by Schisto -LAMP. Light-intensity infections accounted for 16/40; qPCR detected 11/16 (median Ct: 28) and Schisto -LAMP 13/16. qPCR showed the highest diagnostic performance (sensitivity 92.2%, negative predictive value 80.6%, accuracy 94.1%), followed by Schisto- LAMP (sensitivity 81.8%, negative predictive value 64.1%, accuracy 86.3%), with Kato-Katz lowest. Schisto -LAMP outperforms conventional microscopy and provides diagnostic performance close to that of qPCR. Given its simplicity, speed, and minimal equipment requirements, it could be applied in small laboratories in endemic, resource-limited settings, such as rural areas of Madagascar.

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