Low-Cost, Open-Source Colorimetric Platform for Point-of-Care (POC) anti-Human Papillomavirus Type 16 (HPV16) Antibody Detection

Human papillomavirus (HPV) is a leading cause of anogenital and head and neck cancers. HPV type 16 (HPV16) is a significant high-risk strain due to its strong association with these malignancies. The burden of HPV-related cancers is particularly severe in low and middle-income countries (LMICs), where access to diagnostic tools is limited. This work introduces a low-cost, point-of-care (POC) colorimetric platform for detection of antibodies against HPV16. The lateral flow immunoassay (LFIA) developed uses immobilized HPV16 CE2 and E7 proteins for antibody capture and colloidal gold-conjugated secondary for colorimetric labeling. Quantitative readout is achieved via an imaging device that incorporates open-source electronics and 3D-printed components. Analytical sensitivity experiments determined a limit of detection (LOD) at 46 ng/mL. Clinical evaluation of plasma samples (n = 20) from head and neck cancer patients (n = 15) and healthy individuals (n = 5) yielded 94.7% sensitivity, 90.5% specificity, and 92.5% overall accuracy. This study identified a moderate-to-high prevalence of anti-HPV16 antibodies in head and neck cancer patients, with 66.7% testing positive. These results suggest that our platform is a viable tool for detection of anti-HPV16 antibodies, particularly in resource-limited settings where cost-effectiveness and accessibility are crucial.