Background: Modern cervical cancer screening increasingly relies on the use of molecular techniques detecting\nhigh-risk oncogenic human papillomavirus (hr-HPV). A major challenge for developing countries like Ghana has\nbeen the unavailability and costs of HPV DNA-based testing. This study compares the performance of careHPV,\na semi-rapid and affordable qualitative detection assay for 14 hr-HPV genotypes, with HPV genotyping, for the\ndetection of cytological cervical squamous intraepithelial lesions (SIL).\nMethods: A study comparing between frequency matched HIV-1 seropositive and HIV-seronegative women was\nconducted in the Cape Coast Teaching Hospital, Ghana. A systematic sampling method was used to select women\nattending clinics in the hospital. Cervical samples were tested for HPV by careHPV and Anyplex-II HPV28 genotyping\nassay, and by conventional cytology.\nResults: A total of 175 paired results (94 from HIV-1 seropositive and 81 from HIV-seronegative women) were\nanalyzed based on the ability of both tests to detect the 14 hr-HPV types included in the careHPV assay. The\ninter-assay concordance was 94.3% (95%CI: 89.7ââ?¬â??97.2%, kappa = 0.88), similar by HIV serostatus. The careHPV\nassay was equally sensitive among HIV-1 seropositive and seronegative women (97.3% vs. 95.7%, p = 0.50) and slightly\nmore specific among HIV-seronegative women (85.0% vs. 93.1%, p = 0.10). careHPV had good sensitivity (87.5%) but\nlow specificity (52.1%) for the detection of low SIL or greater lesions, but its performance was superior to genotyping\n(87.5 and 38.8%, respectively). Reproducibility of careHPV, tested on 97 samples by the same individual was 82.5%\n(95%CI: 73.4ââ?¬â??89.4%).
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