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Original Research
Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda
Submitted: 06 January 2022 | Published: 19 October 2022
About the author(s)
Anthere Murangwa, Rwanda Military Hospital, Kigali, RwandaKanan T. Desai, Division of Cancer Epidemiology & Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland, United States
Julia C. Gage, Division of Cancer Epidemiology & Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland, United States
Gad Murenzi, Rwanda Military Hospital, Kigali, Rwanda
Patrick Tuyisenge, Rwanda Military Hospital, Kigali, Rwanda
Faustin Kanyabwisha, Rwanda Military Hospital, Kigali, Rwanda
Aimable Musafili, Department of Paediatrics and Child Health, School of Medicine and Pharmacy, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda
Gallican Kubwimana, Rwanda Military Hospital, Kigali, Rwanda; and, Research for Development (RD Rwanda), Kigali, Rwanda
Leon Mutesa, Research for Development (RD Rwanda), Kigali, Rwanda; and, Centre for Human Genetics, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda
Kathryn Anastos, Departments of Medicine and Epidemiology & Population Health, Albert Einstein College of Medicine and Montefiore Health Systems, Bronx, New York, United States
Hae-Young Kim, Department of Public Health, New York Medical College, Valhalla, New York, United States
Philip E. Castle, Division of Cancer Epidemiology & Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland, United States; and, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Rockville, Maryland, United States
Abstract
Background: High-risk human papillomavirus (hrHPV) may cause more than 99% of cervical cancers worldwide. Little is known about performance differences in tests for hrHPV.
Objective: This study analysed agreement for detection of hrHPV between the established, clinically validated Xpert HPV assay and the novel isothermal amplification-based AmpFire HPV genotyping assay.
Methods: This study was nested in a larger project on cervical cancer screening among approximately 5000 women living with HIV in Kigali, Rwanda. This sub-study included 298 participants who underwent initial screening for cervical cancer using the Xpert HPV assay and visual inspection with acetic acid in 2017 and tested positive by either or both. Participants were rescreened using colposcopy, and cervical samples were collected between June 2018 and June 2019. Samples were then tested for HPV using the Xpert HPV assay and AmpFire HPV genotyping assay. Agreement between results from both tests was analysed using an exact version of McNemar test and chi-square test.
Results: Overall agreement and kappa value for detection of hrHPV by Xpert and AmpFire were 89% and 0.77 (95% confidence interval: 0.70–0.85). AmpFire was marginally more likely to diagnose hrHPV-positive than Xpert (p = 0.05), due primarily to the extra positivity for HPV16 (p < 0.001).
Conclusion: Overall, there was good to excellent agreement between the Xpert and AmpFire when testing hrHPV types among women living with HIV. AmpFire was more likely to test extra cases of HPV16, the most carcinogenic HPV type, but the clinical meaning of detecting additional HPV16 infections remains unknown.
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