ArticleInfectious agents and cancer2026
Point-of-care hrHPV mRNA detection with reverse transcription recombinase polymerase amplification on a portable fluorimeter from provider-collected cervical samples in Maputo, Mozambique.
Article in Infectious agents and cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05372484 (Assessment of New Technologies for the Screening and Diagnosis of Cervical Cancer in Mozambique, A Study to be Conducted in Maputo Central Hospital, Mavalane and Jose Macamo General Hospitals and Mavalane Health Center), which is not on this map. Not yet cited in PubMed.
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Assessment of New Technologies for the Screening and Diagnosis of Cervical Cancer in Mozambique, A Study to be Conducted in Maputo Central Hospital, Mavalane and Jose Macamo General Hospitals and Mavalane Health Center
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Abstract
backgroundCervical 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.
methodsCervicovaginal 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.
resultsRT-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.
conclusionsThis 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 registrationThis study was registered on 2022-04-25 on clinicaltrials.gov under registration number NCT05372484.
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