Journal article
Evaluation of p16/Ki-67 dual-stain cytology performed on self-collected vaginal and clinician-collected cervical specimens for the detection of cervical pre-cancer
PJ Toliman, S Phillips, S de Jong, T O'Neill, G Tan, JML Brotherton, M Saville, JM Kaldor, AJ Vallely, SN Tabrizi
Clinical Microbiology and Infection | ELSEVIER SCI LTD | Published : 2020
Abstract
Objectives: To compare the performance of dual immunostaining of p16INK4a and Ki-67 proteins performed on self-collected vaginal specimens and clinician-collected cervical specimens, and to evaluate the performance of this technique in predicting high-grade disease. Methods: Women aged 30–59 years (n = 1005) were recruited at two well-women clinics in Papua New Guinea. Each woman provided both cervical and vaginal specimens that were tested for high-risk human papillomavirus (hrHPV) DNA using the Xpert HPV Test (Cepheid) at point of care. A subset of paired cervical and vaginal specimens (n = 243) were selected to undergo CINTec® PLUS (Roche) p16/Ki-67 dual-stain cytology and liquid-based cy..
View full abstractGrants
Awarded by Roche
Funding Acknowledgements
The authors declare that this evaluation was conducted using CINTec (R) PLUS test kits donated by Roche Diagnostics and Xpert HPV Test cartridges donated by Cepheid. This work was funded by the Papua New Guinea Institute of Medical Research, Papua New Guinea (ICRAS 297/1) (A.J.V.), National Health and Medical Research Council, Australia; NHMRC 1071269 (J.M.K.), and NHMRC 1013209 (A.J.V.).