Authors

L Smith¹;  ¹ London School of Hygiene and Tropical Medicine, UK

Discussion

Background Gynaecological health conditions are neglected in sub-Saharan Africa, with both female genital schistosomiasis and human papillomaviruses causing severe morbidity, leaving women vulnerable to contracting STIs, and potentially leading to cervical cancer. Isothermal molecular assays, which are faster and less energy intensive than PCR, exist for both FGS and HPV. Despite their similar pathology, stigmatising symptoms, and shared sample type, there are currently no multiplex diagnostics for S. haematobium and HPV. Aim To develop and test a multiplex isothermal platform for the diagnosis of Schistosoma haematobium and human papillomavirus in relation to an appropriate use case. Methods The project is split into four main objectives, all in relation to the entire diagnostic pathway. Primary Objective 1: To develop singleplex LAMP and RPA assays in silico before performing assay testing on gDNA and synthetic DNA to develop separate assays. The sensitivity and specificity of both assays will be measured, and these results will be used to inform the development of the multiplex assay, Sh-HPV-Detect. Clinical samples from the longitudinal Zambia-based study ‘Zipime Weka, Schista!’ will be used to evaluate it. Primary Objective 2: To test different storage and extraction methods for S. haematobium and HPV DNA, mimicking the sample type used in endemic countries, and assess their suitability for low-resource settings. Secondary Objective 1: To evaluate the developed Sh-HPV-Detect assay on samples collected from two different FGS studies in Zambia, ‘Zipime Weka, Schista!’ and ‘BILHIV’. Secondary Objective 2: To develop a clinical use case for the Sh-HPV-Detect using information gathered during earlier objectives. Significance Both the symptoms and treatments for FGS and HPV are highly stigmatising for women in sub-Saharan Africa. The availability of a low resource, high sensitivity and specificity molecular diagnostic would allow swifter diagnosis, improving patient outcomes, and assist in reducing stigma