An integrated isothermal nucleic acid amplification test to detect HPV16 and HPV18 DNA in resource-limited settings

Globally, there is an urgent need for low-cost and accessible cervical cancer screening tests. The most sensitive method of cervical cancer screening is testing for high-risk human papillomavirus (HPV) DNA, but current HPV DNA tests are not widely available in resource-limited settings, where the burden of cervical cancer is highest. This talk will outline the recent development of a prototype test that detects two types of HPV DNA – HPV16 and HPV18 – to help meet the need for low-cost cervical cancer screening. The developed test is low-cost, manufacturable, and point-of-care-friendly, enabled by two technologies, isothermal amplification and lateral flow detection, that reduce the cost and complexity of the test. Moreover, the test requires six user steps, produces a result in 45 minutes, and can be performed using small benchtop instruments. In field testing in low- and high-resource settings, the developed test yielded a clinically relevant limit of detection of 1,000 HPV16 or HPV18 DNA copies. Taken together, these results demonstrate the feasibility of an integrated point-of-care HPV DNA test. With the inclusion of additional high-risk HPV types, this test has the potential to meet the need for a point-of-care cervical cancer screening test in resource-limited settings.