A Field‐Deployable RotEx‐LAMP‐LFA Platform for Molecular Triage of HPV‐Driven Oncogenesis

Abstract

Persisting as a major global health disparity, HPV16/18‐associated cervical carcinogenesis continues to disproportionately affect populations in resource‐limited regions with compromised screening infrastructure. While molecular detection of E6/E7 oncogenic transcripts surpasses conventional cytology in clinical specificity, current nucleic acid amplification platforms remain impeded by technical complexity, prolonged turnaround times (>4 h), and substantial per‐test costs (>$50) that hinder scale‐up in low‐income settings. Here, RotEx‐LAMP‐LFA is presented: an innovative point‐of‐care system integrating microfluidic nucleic acid extraction, rapid isothermal amplification (30 min at 63 °C), and combined lateral flow detection in a single disposable cartridge. Validated with 69 clinical specimens (19 histology‐confirmed SCC, 14 HPV+ precancerous lesions, 15 HPV+ infections, and 21 healthy controls), this sample‐to‐answer platform achieved 94.74% sensitivity (18/19; 95% CI: 84.72–100%) for invasive carcinoma detection with 100% (36/36; 95% CI: 90.44‐99.93%) specificity for non‐cancer. In addition, a subset of samples is collected through paired self‐sampling to validate consistency with clinician‐collected specimens, indicating that this innovative platform shows promise for community‐level molecular stratification of persistent and progressive HPV infections. It paves the way for accessible, patient‐centered cervical cancer risk reporting, with the potential to reduce psychological burden on patients.