Point of care, cervical cancer diagnostic test strip that detects HPVs 16 and 18 and their oncoproteins E6 and E7 in first void urine
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Cervical cancer is the second most common cause of cancer-related deaths among women worldwide, with more than 80% of the cases in the developing world. Cervical cancer screening and immediate treatment action reduces its overall prevalence. Various methods have been authorized for early detection of cervical cancer with the most common ones being the pap smear test and cytology test. Although these methods are accurate and, in most cases, diagnose cervical cancer, they necessitate invasive sample acquisition from the cervix thus cause extreme discomfort, are slow to produce results, require skilled personnel and appropriate tools, equipment and infrastructure to produce accurate results making them expensive; these characteristics make cervical cancer screening unpopular for women in low and middle-income countries. First void urine of 100 women between the ages of 21 and 45 years having a positive cervical cancer diagnosis in Kampala, Uganda will be collected and tested for presence of cervical cancer biomarkers; high risk human papillomaviruses (hrHPVs) 16 and 18 as well as their E6 and E7 oncoproteins, using polymerized chain reaction restriction-fragment length polymorphism (PCR-RELP) for the HPVs and Pretect® HPV-Proofer assay for the oncoproteins; presence of these factors in cervical lesions confirms cervical intraepithelial neoplasia (CIN) II, III and invasive cervical cancer. Ability to detect these biomarkers in urine confirms it as an alternative sample to diagnose cervical cancer. A point of care (POC) lateral flow assay (LFA) strip designed with nanoparticle technology, capable of identifying the aforementioned parameters in urine will be designed; appropriate nanoparticles and LFA formats will be chosen. We expect hrHPVs 16 and 18 and their E6 and E7 oncoproteins to be detected in urine and a POC strip capable of effectively detecting them, successfully designed. An effective POC strip capable of effective cervical cancer diagnosis will introduce a faster, non-invasive, affordable, convenient and more socially acceptable technology for use in LMICs, reducing cervical cancer prevalence. Upon receiving funding, we will design and implement this technology first in Uganda and then the rest of East Africa, therein increasing enrollment of patients for cervical cancer diagnosis, reduce time taken to achieve results, increase early treatment hence reduce cervical cancer prevalence.