title: Options in human papillomavirus (HPV) detection for cervical cancer screening: comparison between full genotyping and a rapid qualitative HPV-DNA assay in Ghana.
abstract: BACKGROUND
  Modern cervical cancer screening increasingly relies on the use of molecular techniques detecting high-risk oncogenic human papillomavirus (hr-HPV). A major challenge for developing countries like Ghana has been the unavailability and costs of HPV DNA-based testing. This study compares the performance ofcareHPV, a semi-rapid and affordable qualitative detection assay for 14 hr-HPV genotypes, with HPV genotyping, for the detection of cytological cervical squamous intraepithelial lesions (SIL).
  
  
  METHODS
  A study comparing between frequency matched HIV-1 seropositive and HIV-seronegative women was conducted in the Cape Coast Teaching Hospital, Ghana. A systematic sampling method was used to select women attending clinics in the hospital. Cervical samples were tested for HPV bycareHPV and Anyplex-II HPV28 genotyping assay, and by conventional cytology.
  
  
  RESULTS
  A total of 175 paired results (94 from HIV-1 seropositive and 81 from HIV-seronegative women) were analyzed based on the ability of both tests to detect the 14 hr-HPV types included in thecareHPV assay. The inter-assay concordance was 94.3% (95%CI: 89.7-97.2%, kappa = 0.88), similar by HIV serostatus. ThecareHPV assay was equally sensitive among HIV-1 seropositive and seronegative women (97.3% vs. 95.7%,p= 0.50) and slightly more specific among HIV-seronegative women (85.0% vs. 93.1%,p= 0.10).careHPV had good sensitivity (87.5%) but low specificity (52.1%) for the detection of low SIL or greater lesions, but its performance was superior to genotyping (87.5 and 38.8%, respectively). Reproducibility ofcareHPV, tested on 97 samples by the same individual was 82.5% (95%CI: 73.4-89.4%).
  
  
  CONCLUSIONS
  The performance characteristics ofcareHPV compared to genotyping suggest that this simpler and cheaper HPV detection assay could offer a suitable alternative for HPV screening in Ghana.
authors.affiliation: Department of Microbiology and Immunology, School of Medical Sciences, University of Cape Coast, Cape Coast, Ghana.
authors.forename: Dorcas
authors.initials: D
authors.lastname: Obiri-Yeboah
authors.affiliation: Department of Clinical Microbiology, School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
authors.forename: Yaw
authors.initials: Y
authors.lastname: Adu-Sarkodie
authors.affiliation: Laboratory of Molecular Biology and Genetics (LABIOGENE), University of Ouagadougou, Ouagadougou, Burkina Faso.
authors.forename: Florencia
authors.initials: F
authors.lastname: Djigma
authors.affiliation: Department of Pathology, School of Medical Sciences, University of Cape Coast, Cape Coast, Ghana.
authors.forename: Kafui
authors.initials: K
authors.lastname: Akakpo
authors.affiliation: Department of Microbiology and Immunology, School of Medical Sciences, University of Cape Coast, Cape Coast, Ghana.
authors.forename: Ebenezer
authors.initials: E
authors.lastname: Aniakwa-Bonsu
authors.affiliation: Department of Microbiology and Immunology, School of Medical Sciences, University of Cape Coast, Cape Coast, Ghana.
authors.forename: Daniel
authors.initials: D
authors.lastname: Amoako-Sakyi
authors.affiliation: Laboratory of Molecular Biology and Genetics (LABIOGENE), University of Ouagadougou, Ouagadougou, Burkina Faso.
authors.forename: Simpore
authors.initials: S
authors.lastname: Jacques
authors.affiliation: Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Philippe
authors.initials: P
authors.lastname: Mayaud
keywords: Cervical cancer; Genotyping; Ghana; HIV; Human papillomavirus (HPV); Screening; careHPV