Developing and Validating a Loop-Mediated Isothermal Amplification Assay for Point-of-Care Diagnosis of Schistosoma haematobium in Rural Nigerian Communities

Accurate point-of-care diagnosis of Schistosoma haematobium is a critical unmet need in rural Nigerian communities where microscopy is unavailable and urine dipstick tests lack specificity for epidemiological decision-making. This doctoral research develops and validates a loop-mediated isothermal amplification assay for point-of-care diagnosis of S. haematobium in field conditions in rural Nigeria. The development phase involved designing LAMP primers targeting the S. haematobium-specific Dra1 tandem repeat sequence using PrimerExplorer software, followed by in silico cross-reactivity screening against non-target Schistosoma species and common co-endemic helminths. Laboratory validation was performed at the University of Maiduguri using purified parasite DNA and urine specimens from 100 confirmed S. haematobium-positive and 100 negative samples collected from Borno and Yobe States. Field validation was conducted in three rural communities in Jere Local Government Area, comparing LAMP against membrane filtration microscopy as the gold standard and the urine dipstick haematuria test in 500 participants. Diagnostic sensitivity, specificity, positive and negative predictive values, and kappa agreement were calculated. Usability assessment evaluated the technical competence required, processing time, equipment needs, and cost per test compared with microscopy. Evidence from 2020 to 2024 confirms LAMP as a highly sensitive and specific diagnostic platform validated for multiple helminth species in African field settings. This research produces a validated S. haematobium LAMP protocol optimised for low-resource rural Nigerian deployment. Keywords: LAMP assay, Schistosoma haematobium, point-of-care diagnosis, rural Nigeria, diagnostic validation.