Performance of p16INK4a ELISA as a primary cervical cancer screening test among a large cohort of HIV-infected women in western Kenya

• Verfasst von: Wu, Tara J. [VerfasserIn]
• Verfasst von: Smith-McCune, Karen [VerfasserIn]
• Verfasst von: Reuschenbach, Miriam [VerfasserIn]
• Verfasst von: Knebel Doeberitz, Magnus von [VerfasserIn]
• Verfasst von: Maloba, May [VerfasserIn]
• Verfasst von: Huchko, Megan J. [VerfasserIn]
• Titel: Performance of p16INK4a ELISA as a primary cervical cancer screening test among a large cohort of HIV-infected women in western Kenya
• Titelzusatz: a 2-year cross-sectional study
• Verf.angabe: Tara J. Wu, Karen Smith-McCune, Miriam Reuschenbach, Magnus von Knebel Doeberitz, May Maloba, Megan J. Huchko
• E-Jahr: 2016
• Jahr: September 13, 2016
• Umfang: 10 S.
• Teil: volume:6
• Teil: year:2016
• Teil: number:9
• Teil: elocationid:e012547
• Teil: pages:1-10
• Teil: extent:10
• Fussnoten: Gesehen am 10.09.2021 ; Der Ausdruck "INK4a" ist im Titel hochgestellt
• Titel Quelle: Enthalten in: BMJ open
• Ort Quelle: London : BMJ Publishing Group, 2011
• Jahr Quelle: 2016
• Band/Heft Quelle: 6(2016), 9, Artikel-ID e012547, Seite 1-10
• ISSN Quelle: 2044-6055
• DOI: doi:10.1136/bmjopen-2016-012547
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: cervical cancer screening
• Sach-SW: CIN2+
• Sach-SW: HIV
• Sach-SW: Kenya
• Sach-SW: p16INK4a ELISA
• K10plus-PPN: 1769998675

Abstract

Objective A biomarker with increased specificity for cervical dysplasia compared with human papillomavirus (HPV) testing would be an attractive option for cervical cancer screening among HIV-infected women in resource-limited settings. p16INK4a has been explored as a biomarker for screening in general populations. - Design A 2-year cross-sectional study. - Setting 2 large HIV primary care clinics in western Kenya. - Participants 1054 HIV-infected women in western Kenya undergoing cervical cancer screening as part of routine HIV care from October 2010 to November 2012. - Interventions Participants underwent p16INK4a specimen collection and colposcopy. Lesions with unsatisfactory colposcopy or suspicious for cervical intraepithelial neoplasia 2+ (CIN2+; including CIN2/3 or invasive cervical cancer) were biopsied. Following biopsy, disease status was determined by histopathological diagnosis. - Primary and secondary outcome measures We measured the sensitivity, specificity and predictive values of p16INK4a ELISA for CIN2+ detection among HIV-infected women and compared them to the test characteristics of current screening methods used in general as well as HIV-infected populations. - Results Average p16INK4a concentration in cervical samples was 37.4 U/mL. After colposcopically directed biopsy, 127 (12%) women were determined to have CIN2+. Receiver operating characteristic analysis showed an area under the curve of 0.664 for p16INK4a to detect biopsy-proven CIN2+. At a p16INK4a cut-off level of 9 U/mL, sensitivity, specificity, positive and negative predictive values were 89.0%, 22.9%, 13.6% and 93.8%, respectively. The overall p16INK4a positivity at a cut-off level of 9 U/mL was 828 (78.6%) women. There were 325 (30.8%) cases of correct p16INK4a prediction to detect or rule out CIN2+, and 729 (69.2%) cases of incorrect p16INK4a prediction. - Conclusions p16INK4a ELISA did not perform well as a screening test for CIN2+ detection among HIV-infected women due to low specificity. Our study contributes to the ongoing search for a more specific alternative to HPV testing for CIN2+ detection.