Abstract
Accurate diagnosis of urogenital schistosomiasis is crucial for disease surveillance and control. Routine diagnostic methods, however, lack sensitivity when assessing patients with low levels of infection still able to maintain pathogen transmission. Therefore, there is a need for highly sensitive diagnostic tools that can be used at the point-of-care in endemic areas. Recombinase polymerase amplification (RPA) is a rapid and sensitive diagnostic tool that has been used to diagnose several pathogens at the point-of-care. Here, the analytical performance of a previously developed RPA assay (RT-ShDra1-RPA) targeting the Schistosoma haematobium Dra1 genomic region was assessed using commercially synthesised S. haematobium Dra1 copies and laboratory-prepared samples spiked with S. haematobium eggs. Clinical performance was also assessed by comparing diagnostic outcomes with that of a reference diagnostic standard, urine-egg microscopy. The RT-ShDra1-RPA was able to detect 1 × 101 copies of commercially synthesised Dra1 DNA as well as one S. haematobium egg within laboratory-spiked ddH2O samples. When compared with urine-egg microscopy, the overall sensitivity and specificity of the RT-ShDra1-RPA assay was 93.7% (±88.7–96.9) and 100% (±69.1–100), respectively. Positive and negative predictive values were 100% (±97.5–100) and 50% (±27.2–72.8), respectively. The RT-ShDra1-RPA therefore shows promise as a rapid and highly sensitive diagnostic tool able to diagnose urogenital schistosomiasis at the point-of-care.
Highlights
Schistosomiasis is a debilitating neglected tropical disease (NTD), caused by infection with parasitic blood-fluke trematodes of the genus Schistosoma, that afflicts over 230 million people within78 countries [1,2]
Cell-driven granulomatous response that can cause a range of clinical morbidities including severe abdominal pain, destruction of the bladder wall, haematuria, severe kidney disease and, in chronic cases, bladder cancer [1,6]
female genital schistosomiasis (FGS)-associated destruction of the cervicovaginal mucosa is recognised as an important contributor to the transmission of sexually transmitted bacterial and viral infections (STIs), including human immunodeficiency virus (HIV) and human papillomavirus (HPV), which can cause cervical cancer [9,10,11]
Summary
Schistosomiasis is a debilitating neglected tropical disease (NTD), caused by infection with parasitic blood-fluke trematodes of the genus Schistosoma, that afflicts over 230 million people within78 countries [1,2]. Rather than being passed in the urine, to perpetuate the parasite’s life cycle, a large proportion of eggs will become sequestered throughout the genital tract. This evokes a T helper type-2 (Th2). Cell-driven granulomatous response that can cause a range of clinical morbidities including severe abdominal pain, destruction of the bladder wall, haematuria, severe kidney disease and, in chronic cases, bladder cancer [1,6]. FGS-associated destruction of the cervicovaginal mucosa is recognised as an important contributor to the transmission of sexually transmitted bacterial and viral infections (STIs), including human immunodeficiency virus (HIV) and human papillomavirus (HPV), which can cause cervical cancer [9,10,11]
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