title: Clinical Performance Validation of 4 Point-of-Care Cervical Cancer Screening Tests in HIV-Infected Women in Zambia.
abstract: OBJECTIVE
  We sought to determine the clinical performance of visual inspection with acetic acid (VIA), digital cervicography (DC), Xpert human papillomavirus (HPV), and OncoE6 for cervical cancer screening in an HIV-infected population.
  
  
  METHODS
  HIV-infected women 18 years or older were included in this cross-sectional validation study conducted in Lusaka, Zambia. The screening tests were compared against a histological gold standard. We calculated sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios, and odds ratios using cervical intraepithelial neoplasia grade 2 or worse (CIN 2+) and grade 3 or worse (CIN 3+) thresholds.
  
  
  RESULTS
  Between January and June 2015, a total of 200 women were enrolled. Fifteen percent were screen positive by VIA, 20% by DC, 47% by Xpert HPV, and 6% by OncoE6. Using a CIN 2+ threshold, the sensitivity and specificity of VIA were 48% (95% CI = 30%-67%) and 92% (95% CI = 86%-95%), respectively. Similarly, the sensitivity and specificity of DC were 59% (95% CI = 41%-76%) and 88% (95% CI = 82%-93%), respectively. The sensitivity and specificity of Xpert HPV were 88% (95% CI = 71%-97%) and 60% (95% CI = 52%-68%), respectively. Finally, the sensitivity and specificity of OncoE6 were 31% (95% CI = 16%-50%) and 99% (95% CI = 97%-100%), respectively.
  
  
  CONCLUSIONS
  VIA and DC displayed moderate sensitivity and high specificity. Xpert HPV performed equivalently to currently approved HPV DNA tests, with high sensitivity and moderate specificity. OncoE6 displayed excellent specificity but low sensitivity. These results confirm an important role for VIA, DC, and Xpert HPV in screen-and-treat cervical cancer prevention in low- and middle-income countries, such as Zambia.
authors.affiliation: 1Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC; 2Centre for Infectious Disease Research in Zambia; 3Department of Pathology, Cancer Diseases Hospital; 4Department of Obstetrics and Gynaecology, University Teaching Hospital; and 5Department of Department of Biomedical Sciences, School of Medicine, University of Zambia, Lusaka, Zambia.
authors.forename: Carla J
authors.initials: CJ
authors.lastname: Chibwesha
authors.forename: Brigitte
authors.initials: B
authors.lastname: Frett
authors.forename: Katundu
authors.initials: K
authors.lastname: Katundu
authors.forename: Allen C
authors.initials: AC
authors.lastname: Bateman
authors.forename: Aaron
authors.initials: A
authors.lastname: Shibemba
authors.forename: Sharon
authors.initials: S
authors.lastname: Kapambwe
authors.forename: Mulindi H
authors.initials: MH
authors.lastname: Mwanahamuntu
authors.forename: Susan
authors.initials: S
authors.lastname: Banda
authors.forename: Chalwa
authors.initials: C
authors.lastname: Hamusimbi
authors.forename: Pascal
authors.initials: P
authors.lastname: Polepole
authors.forename: Groesbeck P
authors.initials: GP
authors.lastname: Parham
mesh_terms: D000328:Adult; D003430:Cross-Sectional Studies; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000150:complications; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D015024:Zambia