HARP Project

HARP has it’s second paper accepted for publication on 12 November 2014:

Ngou J, Gilham C, Omar T, Goumbri-Lompo O, Doutre S, Michelow P, Kelly H, Didelot MN, Chikandiwa A, Sawadogo B, Delany-Moretlwe S, Meda N, Costes V, Mayaud P, Segondy M. 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. J Acquir Immune Defic Syndr (JAIDS) 2014 Nov 12 [Epub ahead of print].

The abstract is available below and a copy of the accepted/final peer-reviewed manuscript is available to view via the following link: http://www.ncbi.nlm.nih.gov/pubmed/25394189

Abstract

Objectives: To compare the Hybrid Capture-2 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 (hr)-HPV and performance to detect squamous intraepithelial lesions, 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%CI, 0.43-0.53)]. Agreement improved with analysis restricted to women with high-grade cervical lesions [adjusted Kappa coefficient value, 0.83 (95%CI, 0.74-0.91)]. 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 ASCUS, 51.8% and 75.2%, respectively in samples with LSIL, and 86.3% and 89.8%, respectively in samples with HSIL/ASC-H. Sensitivity, specificity, positive and negative predictive values for 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.

Conclusion: HC2 has lower analytical sensitivity but higher specificity than INNO-LiPA for diagnosing high-grade lesions; the two 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.