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.