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J Clin Microbiol. 2016 Jul;54(7):1734-1737. doi: 10.1128/JCM.00529-16. Epub 2016 Apr 13.

Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens.

Author information

1
Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
2
The Kirby Institute, UNSW Australia, Sydney, Australia.
3
Eastern Highlands Provincial Hospital, Goroka, Papua New Guinea.
4
Mt. Hagen General Hospital, Western Highlands Province, Mt. Hagen, Papua New Guinea.
5
The Burnet Institute, Melbourne, Australia.
6
School of Public Health and Community Medicine, UNSW Australia, Sydney, Australia.
7
Department of Obstetrics and Gynaecology, School of Medicine and Health Sciences, University of Papua New Guinea, National Capital District, Papua New Guinea.
8
Department of Microbiology, The Royal Women's Hospital, Parkville, Victoria, Australia.
9
Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australia.
10
Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea avallely@kirby.unsw.edu.au.

Abstract

The World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both specimen types were tested at the point of care by using the Xpert HPV test. Women were given their cervical test result the same day. Those with a positive hrHPV test and positive examination upon visual inspection of the cervix with acetic acid were offered same-day cervical cryotherapy. A total of 1,005 women were enrolled, with 124 (12.3%; 95% confidence interval [CI], 10.3%, 14.4%) being positive for any hrHPV infection. There was a 99.4% overall percent agreement (OPA) between vaginal and cervical tests for HPV-16 (95% CI, 98.9%, 99.9%), a 98.5% OPA for HPV-18/45 (95% CI, 97.7%, 99.3%), a 94.4% OPA for other hrHPV infections (95% CI, 92.9%, 95.9%), and a 93.4% OPA for all hrHPV types combined (95% CI, 91.8%, 95.0%). Self-collected vaginal specimens had excellent agreement with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. This approach provides for the first time an opportunity to incorporate point-of-care hrHPV testing into clinical cervical screening algorithms in high-burden, low-income settings.

PMID:
27076663
PMCID:
PMC4922075
DOI:
10.1128/JCM.00529-16
[Indexed for MEDLINE]
Free PMC Article

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