Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy

Objective To explore the utility of extended Human Papillomavirus (HPV) genotyping to detect cervical intraepithelial neoplasia grade 2 or more (CIN2+) in a ‘screen-and-treat’ strategy for HPV-positive women in low-resource settings.Design Prospective study of diagnostic accuracy.Setting The study t...

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Main Authors: Pierre Vassilakos, Evelyn Tincho, Bruno Kenfack, Patrick Petignat, Ania Wisniak, Celine Broquet, François Marcel Ndam Nsangou, Michel Noubom, Emilien Jeannot
Format: Article
Language:English
Published: BMJ Publishing Group 2022-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/12/e057234.full
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author Pierre Vassilakos
Evelyn Tincho
Bruno Kenfack
Patrick Petignat
Ania Wisniak
Celine Broquet
François Marcel Ndam Nsangou
Michel Noubom
Emilien Jeannot
author_facet Pierre Vassilakos
Evelyn Tincho
Bruno Kenfack
Patrick Petignat
Ania Wisniak
Celine Broquet
François Marcel Ndam Nsangou
Michel Noubom
Emilien Jeannot
author_sort Pierre Vassilakos
collection DOAJ
description Objective To explore the utility of extended Human Papillomavirus (HPV) genotyping to detect cervical intraepithelial neoplasia grade 2 or more (CIN2+) in a ‘screen-and-treat’ strategy for HPV-positive women in low-resource settings.Design Prospective study of diagnostic accuracy.Setting The study took place in West Cameroon between September 2018 and March 2020.Participants 2014 women were recruited. Asymptomatic, non-pregnant women aged 30–49 years without history of CIN treatment, anogenital cancer or hysterectomy were eligible.Interventions Participants performed self-sampling for HPV testing with GeneXpert followed by visual inspection with acetic acid and Lugol’s iodine (VIA) triage before treatment if required.Main outcome measures Liquid-based cytology, biopsies and endocervical brushing were performed in HPV-positive women as quality control. We assessed the detection rate of CIN2+ by HPV genotyping (two pools of genotypes obtained from the Xpert system, pool_1 (HPV 16, 18, 45) and pool_2 (HPV 16, 18, 45, 31, 33, 35, 52, 58)), VIA and cytology.Results 382 (18.2%) women were HPV-positive among which 11.5% (n=44) were CIN2+. Of those 44 participants, 41 were triaged positive by extended genotyping, versus 35 by VIA and 33 by cytology. Overall, triage positivity was of 68.4% for extended genotyping, 59.3% for VIA and 14.8% for cytology, with false positive rates of 83.4%, 84.1% and 37.7%, respectively. Extended genotyping had a higher sensitivity for CIN2+ detection (93.2%, CI: 81.3 to 98.6) than VIA (79.5%, CI: 64.7 to 90.2, p=0.034) and cytology (75.0%, CI: 59.7 to 86.8, p=0.005). No significant difference was observed in the overtreatment rate in triaged women by extended genotyping or VIA (9.9%, CI: 8.6 to 11.3, and 8.8%, CI: 7.7 to 10.1), with a ratio of 6.0 and 6.3 women treated per CIN2+ diagnosed.Conclusion Triage of HPV-positive women with extended HPV genotyping improves CIN2+ detection compared with VIA with a minor loss of specificity and could be used to optimize the management of HPV-positive women.Trial registration number NCT03757299.
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spelling doaj-art-754ce4c50e3546ebbe02b9e7b00ddc862025-08-20T02:14:54ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2021-057234Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracyPierre Vassilakos0Evelyn Tincho1Bruno Kenfack2Patrick Petignat3Ania Wisniak4Celine Broquet5François Marcel Ndam Nsangou6Michel Noubom7Emilien Jeannot8Geneva Foundation for Medical Education and Research, Geneva, SwitzerlandDepartment of Gynecology, Obstetrics and Maternal Health, University of Dschang, Dschang District Hospital, Dschang, CameroonDepartment of Gynecology, Obstetrics and Maternal Health, University of Dschang, Dschang District Hospital, Dschang, CameroonGeneva University Hospitals Department of Gynaecology and Obstetrics, Geneva, SwitzerlandGeneva University Hospitals Department of Gynaecology and Obstetrics, Geneva, SwitzerlandObstetrics and Gynecology, Geneva University Hospitals, Geneva, SwitzerlandDepartment of Gynecology, Obstetrics and Maternal Health, University of Dschang, Dschang District Hospital, Dschang, CameroonDepartment of Gynecology, Obstetrics and Maternal Health, University of Dschang, Dschang District Hospital, Dschang, CameroonInstitute of Global Health, Faculty of Medicine, University of Geneva, Geneva, SwitzerlandObjective To explore the utility of extended Human Papillomavirus (HPV) genotyping to detect cervical intraepithelial neoplasia grade 2 or more (CIN2+) in a ‘screen-and-treat’ strategy for HPV-positive women in low-resource settings.Design Prospective study of diagnostic accuracy.Setting The study took place in West Cameroon between September 2018 and March 2020.Participants 2014 women were recruited. Asymptomatic, non-pregnant women aged 30–49 years without history of CIN treatment, anogenital cancer or hysterectomy were eligible.Interventions Participants performed self-sampling for HPV testing with GeneXpert followed by visual inspection with acetic acid and Lugol’s iodine (VIA) triage before treatment if required.Main outcome measures Liquid-based cytology, biopsies and endocervical brushing were performed in HPV-positive women as quality control. We assessed the detection rate of CIN2+ by HPV genotyping (two pools of genotypes obtained from the Xpert system, pool_1 (HPV 16, 18, 45) and pool_2 (HPV 16, 18, 45, 31, 33, 35, 52, 58)), VIA and cytology.Results 382 (18.2%) women were HPV-positive among which 11.5% (n=44) were CIN2+. Of those 44 participants, 41 were triaged positive by extended genotyping, versus 35 by VIA and 33 by cytology. Overall, triage positivity was of 68.4% for extended genotyping, 59.3% for VIA and 14.8% for cytology, with false positive rates of 83.4%, 84.1% and 37.7%, respectively. Extended genotyping had a higher sensitivity for CIN2+ detection (93.2%, CI: 81.3 to 98.6) than VIA (79.5%, CI: 64.7 to 90.2, p=0.034) and cytology (75.0%, CI: 59.7 to 86.8, p=0.005). No significant difference was observed in the overtreatment rate in triaged women by extended genotyping or VIA (9.9%, CI: 8.6 to 11.3, and 8.8%, CI: 7.7 to 10.1), with a ratio of 6.0 and 6.3 women treated per CIN2+ diagnosed.Conclusion Triage of HPV-positive women with extended HPV genotyping improves CIN2+ detection compared with VIA with a minor loss of specificity and could be used to optimize the management of HPV-positive women.Trial registration number NCT03757299.https://bmjopen.bmj.com/content/12/12/e057234.full
spellingShingle Pierre Vassilakos
Evelyn Tincho
Bruno Kenfack
Patrick Petignat
Ania Wisniak
Celine Broquet
François Marcel Ndam Nsangou
Michel Noubom
Emilien Jeannot
Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy
BMJ Open
title Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy
title_full Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy
title_fullStr Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy
title_full_unstemmed Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy
title_short Utility of extended HPV genotyping for the triage of self-sampled HPV-positive women in a screen-and-treat strategy for cervical cancer prevention in Cameroon: a prospective study of diagnostic accuracy
title_sort utility of extended hpv genotyping for the triage of self sampled hpv positive women in a screen and treat strategy for cervical cancer prevention in cameroon a prospective study of diagnostic accuracy
url https://bmjopen.bmj.com/content/12/12/e057234.full
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