Point-of-Care hrHPV mRNA Detection With Reverse Transcription Recombinase Polymerase Amplification on a Portable Fluorimeter From Provider-Collected Cervical Samples in Maputo, Mozambique

Authors

• Emilie Newsham Novak
• Cannon J Hansen
• Zoha Wazir
• Ariel Ma
• Jennifer Carns
• Hira Atif
• Jane R Montealegre
• Michael E Scheurer
• Cesaltina Lorenzoni
• Daniel G Rosen
• Mila P Salcedo
• Kathleen M Schmeler
• Rebecca R Richards-Kortum

Language

English

Publication Date

6-23-2026

Journal

Infectious Agents and Cancer

DOI

10.1186/s13027-026-00772-5

PMID

42337609

Abstract

Background: Cervical cancer is the most common cancer in women in Mozambique, where limited screening infrastructure contributes to high disease burden. While testing for high-risk human papillomavirus (hrHPV) DNA can identify women at risk for cervical cancer, its limited specificity may lead to overtreatment in screen-and-treat programs, straining resources. We performed a pilot study to evaluate preliminary feasibility of a novel, accessible test to detect hrHPV mRNA, a more specific biomarker for cervical cancer risk, from 22 women who previously screened positive for visual inspection with acetic acid at Maputo Central Hospital in Mozambique.

Methods: Cervicovaginal samples were analyzed for hrHPV DNA using the Xpert HPV test. RNA was extracted from samples using a benchtop spinner instead of a centrifuge. Isothermal reverse transcription recombinase polymerase amplification (RT-RPA) assays targeting HPV 16, 18, and 45 mRNA, plus a cellular control were performed on a portable fluorimeter with results compared to the gold standard portable reverse transcription quantitative polymerase chain reaction (RT-qPCR). Cervical biopsies were obtained and submitted for histopathologic analysis.

Results: RT-RPA and RT-qPCR results were in 100% agreement (22/22). The sample-to-answer times were 1.5 h for the RT-RPA test and 3.75 h for RT-qPCR. All RT-RPA-positive samples were Xpert-positive for the same HPV type. Two Xpert-positive samples were RT-RPA-negative; four were positive for high-risk HPV types other than 16, 18, or 45. RT-RPA had a higher positive predictive value (100%) for high grade lesions by biopsy than Xpert (73%). Xpert had a higher negative predictive value (82%) than RT-RPA (71%) for high grade lesions.

Conclusions: This study demonstrates the potential feasibility of novel point-of-care hrHPV mRNA testing in a low-income country. Additional work is needed before this test is clinically relevant and deployable in resource-limited settings.

Keywords

Cervical cancer, Human papillomavirus, Point-of-care, mRNA

Comments

Trial registration: This study was registered on 2022-04-25 on clinicaltrials.gov under registration number NCT05372484.

Published Open-Access

yes

Recommended Citation

Novak, Emilie Newsham; Hansen, Cannon J; Wazir, Zoha; et al., "Point-of-Care hrHPV mRNA Detection With Reverse Transcription Recombinase Polymerase Amplification on a Portable Fluorimeter From Provider-Collected Cervical Samples in Maputo, Mozambique" (2026). Faculty, Staff and Students Publications. 7034.
https://digitalcommons.library.tmc.edu/baylor_docs/7034