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J Acquir Immune Defic Syndr. 2015 Feb 1;68(2):162-8. doi: 10.1097/QAI.0000000000000428.

Comparison of analytical and clinical performances of the digene HC2 HPV DNA assay and the INNO-LiPA HPV genotyping assay for detecting high-risk HPV infection and cervical neoplasia among HIV-positive African women.

Author information

1
*INSERM U1058 and Department of Biology and Pathology, Montpellier University Hospital (CHU), Montpellier, France; †Departments of Clinical Research and 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 and Centre of International Research for Health, University of Ouagadougou, Ouagadougou, Burkina Faso; and ‖Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.

Abstract

OBJECTIVES:

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.

PMID:
25394189
DOI:
10.1097/QAI.0000000000000428
[Indexed for MEDLINE]

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