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Background <p>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.</p> Methods <p>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.</p> Results <p>RT-RPA and RT-qPCR results were in 100% agreement (22/22). The sample-to-answer times were 1.5&#xa0;h for the RT-RPA test and 3.75&#xa0;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.</p> Conclusions <p>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.</p> Trial registration <p>This study was registered on 2022-04-25 on clinicaltrials.gov under registration number NCT05372484.</p>

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Point-of-care hrHPV mRNA detection with reverse transcription recombinase polymerase amplification on a portable fluorimeter from provider-collected cervical samples in Maputo, Mozambique

  • 期刊论文

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  • 发表日期：

    2026年6月23日

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  • 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

摘要

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.

Trial registration

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