Ngou J., Gilham C., Omar T., Goumbri-Lompo O., Doutre S., Michelow P., Kelly H., Didelot M.-N., Chikandiwa A., Sawadogo B., Delany-Moretlwe S., Meda N., Costes V., Mayaud P., Segondy M.
INSERM, Department of Biology and Pathology, Montpellier University Hospital, Montpellier, France; Departments of Clinical Research, Non Communicable Diseases Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom; Department of Anatomical Pathology, University of the Witwatersrand, Johannesburg, South Africa; University Hospital, Centre of International Research for Health, University of Ouagadougou, Ouagadougou, Burkina Faso; Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa
Ngou, J., INSERM, Department of Biology and Pathology, Montpellier University Hospital, Montpellier, France; Gilham, C., Departments of Clinical Research, Non Communicable Diseases Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom; Omar, T., Department of Anatomical Pathology, University of the Witwatersrand, Johannesburg, South Africa; Goumbri-Lompo, O., University Hospital, Centre of International Research for Health, University of Ouagadougou, Ouagadougou, Burkina Faso; Doutre, S., INSERM, Department of Biology and Pathology, Montpellier University Hospital, Montpellier, France; Michelow, P., Department of Anatomical Pathology, University of the Witwatersrand, Johannesburg, South Africa; Kelly, H., Departments of Clinical Research, Non Communicable Diseases Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom; Didelot, M.-N., INSERM, Department of Biology and Pathology, Montpellier University Hospital, Montpellier, France; Chikandiwa, A., Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa; Sawadogo, B., University Hospital, Centre of International Research for Health, University of Ouagadougou, Ouagadougou, Burkina Faso; Delany-Moretlwe, S., Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa; Meda, N., University Hospital, Centre of International Research for Health, University of Ouagadougou, Ouagadougou, Burkina Faso; Costes, V., INSERM, Department of Biology and Pathology, Montpellier University Hospital, Montpellier, France; Mayaud, P., Departments of Clinical Research, Non Communicable Diseases Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom, Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa; Segondy, M., INSERM, Department of Biology and Pathology, Montpellier University Hospital, Montpellier, France
To compare the Hybrid Capture 2 human papillomaviruses (HPV) DNA assay (HC2) and the INNO-LiPA HPV Genotyping Extra assay (INNO-LiPA) for cervical cancer screening in HIV-1-infected African women. DESIGN:: The tests were compared for agreement in detecting high-risk HPV (hr-HPV) and performance to detect squamous intraepithelial lesions (SIL), by cytology, and cervical intraepithelial neoplasia, by histology, in cervical samples from 1224 women in Burkina Faso (N = 604) and South Africa (N = 620). RESULTS:: When considering the 13 hr-HPV types detected by HC2, 634 (51.8%) and 849 (69.4%) samples were positive by HC2 and INNO-LiPA, respectively. Agreement between assays was 73.9% [adjusted kappa coefficient value, 0.44 (95% confidence interval: 0.43 to 0.53)]. Agreement improved with analysis restricted to women with high-grade cervical lesions [adjusted kappa coefficient value, 0.83 (95% confidence interval: 0.74 to 0.91)]. The prevalence of hr-HPV, as determined by HC2 and INNO-LiPA, was 34.5% and 54.5%, respectively, in samples with normal cytology, 48.0% and 68.0%, respectively, in samples with atypical squamous cells of undetermined significance, 51.8% and 75.2%, respectively, in samples with low-grade SIL, and 86.3% and 89.8%, respectively, in samples with high-grade SIL/atypical squamous cells that cannot exclude HSIL. Sensitivity, specificity, positive, and negative predictive values for the diagnosis of histological high-grade lesions (CIN2+) were 88.8%, 55.2%, 24.7% and 96.7%, and 92.5%, 35.1%, 19.1% and 96.6% for HC2 and INNO-LiPA, respectively. CONCLUSIONS:: HC2 has lower analytical sensitivity but higher specificity than INNO-LiPA for diagnosing high-grade lesions; the 2 tests presented a comparable clinical sensitivity. HC2 might be suitable for cervical cancer screening in HIV-1-infected African women, but its use in resource-limited settings merits to be further evaluated in comparison with other prevention strategies. © 2014 Wolters Kluwer Health, Inc.