A multicountry evaluation of carehpv testing, visual inspection with acetic acid, and papanicolaou testing for the detection of cervical cancer
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Authors
Jeronimo, Jose
Bansil, Pooja
Lim, Jeanette
Peck, Roger
Paul, Proma
Amador, Juan Jose
Mirembe, Florence
Byamugisha, Josaphat
Poli, Usha Rani
Satyanarayana, Labani
Issue Date
2014-03-03
Type
Article
Language
en_US
Keywords
Cancer Prevention and Control , Early Detection , Cervical Cancer , Low-Resource Settings , HPV
Alternative Title
Abstract
Objective:
This study evaluates the feasibility and performance of careHPV, a novel human papillomavirus (HPV) DNA test, when used for screening women for cervical cancer in low-resource settings.
Methods and Materials:
Clinician-collected (cervical) and self-collected (vaginal) careHPV specimens, visual inspection with acetic acid (VIA), and Papanicolaou test were evaluated among 16,951 eligible women in India, Nicaragua, and Uganda. Women with positive screening results received colposcopy and histologic follow-up as indicated. The positivity of each screening method was calculated overall, by site, and age. In addition, the clinical performance of each screening test was determined for detection of cervical intraepithelial neoplasia (CIN) grade 2 (CIN2+) and CIN grade 3.
Results:
Moderate or severe dysplasia or cancer (taken together as CIN2+) was diagnosed in 286 women. The positivity rate ranged between 2.4% to 19.6% for vaginal careHPV, 2.9% to 20.2% for cervical careHPV, 5.5% to 34.4% for VIA, and 2.8% to 51.8% for Papanicolaou test. Cervical careHPV was the most sensitive for CIN2+ (81.5%; 95% confidence interval [CI], 76.5–85.8) and CIN grade 3 (85.3%; 95% CI, 78.6–90.6) at all sites, followed by vaginal careHPV (69.6% and 71.3%, respectively). The sensitivity of VIA ranged from 21.9% to 73.6% and Papanicolaou test from 40.7% to 73.7%. The pooled specificities of cervical careHPV, vaginal careHPV, VIA, and Papanicolaou test were 91.6%, 90.6%, 84.2%, and 87.7%, respectively.
Conclusions:
careHPV performed well in large multicountry demonstration studies conducted in resource-limited settings that have not previously been conducted this type of testing; its sensitivity using cervical samples or vaginal self-collected samples was better than VIA or Papanicolaou test. The feasibility of using careHPV in self-collected vaginal samples opens the possibility of increasing coverage and early detection in resource-constrained areas.
Description
Citation
Jeronimo, J., Bansil, P., Lim, J., Peck, R., Paul, P., Amador, J. J., Mirembe, F., Byamugisha, J., Poli, U. R., Satyanarayana, L., Asthana, S., & START-UP Study Group (2014). A multicountry evaluation of careHPV testing, visual inspection with acetic acid, and papanicolaou testing for the detection of cervical cancer. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 24(3), 576–585. https://doi.org/10.1097/IGC.0000000000000084
Publisher
International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society