title: 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.
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.
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
authors.forename: P
authors.initials: P
authors.lastname: Toliman
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, Australia.
authors.forename: S G
authors.initials: SG
authors.lastname: Badman
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
authors.forename: J
authors.initials: J
authors.lastname: Gabuzzi
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
authors.forename: S
authors.initials: S
authors.lastname: Silim
authors.affiliation: Eastern Highlands Provincial Hospital, Goroka, Papua New Guinea.
authors.forename: L
authors.initials: L
authors.lastname: Forereme
authors.affiliation: Eastern Highlands Provincial Hospital, Goroka, Papua New Guinea.
authors.forename: A
authors.initials: A
authors.lastname: Kumbia
authors.affiliation: Mt. Hagen General Hospital, Western Highlands Province, Mt. Hagen, Papua New Guinea.
authors.forename: B
authors.initials: B
authors.lastname: Kombuk
authors.affiliation: Mt. Hagen General Hospital, Western Highlands Province, Mt. Hagen, Papua New Guinea.
authors.forename: Z
authors.initials: Z
authors.lastname: Kombati
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
authors.forename: J
authors.initials: J
authors.lastname: Allan
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
authors.forename: G
authors.initials: G
authors.lastname: Munnull
authors.affiliation: The Burnet Institute, Melbourne, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Ryan
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.|The Kirby Institute, UNSW Australia, Sydney, Australia.
authors.forename: L M
authors.initials: LM
authors.lastname: Vallely
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.|School of Public Health and Community Medicine, UNSW Australia, Sydney, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Kelly-Hanku
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, Australia.
authors.forename: H
authors.initials: H
authors.lastname: Wand
authors.affiliation: Department of Obstetrics and Gynaecology, School of Medicine and Health Sciences, University of Papua New Guinea, National Capital District, Papua New Guinea.
authors.forename: G D L
authors.initials: GDL
authors.lastname: Mola
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Guy
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
authors.forename: P
authors.initials: P
authors.lastname: Siba
authors.affiliation: The Kirby Institute, UNSW Australia, Sydney, Australia.
authors.forename: J M
authors.initials: JM
authors.lastname: Kaldor
authors.affiliation: Department of Microbiology, The Royal Women's Hospital, Parkville, Victoria, Australia.|Department of Obstetrics and Gynaecology, University of Melbourne, Victoria, Australia.
authors.forename: S N
authors.initials: SN
authors.lastname: Tabrizi
authors.affiliation: Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea avallely@kirby.unsw.edu.au.|The Kirby Institute, UNSW Australia, Sydney, Australia.
authors.forename: A J
authors.initials: AJ
authors.lastname: Vallely
mesh_terms: D000328:Adult; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D010219:Papua New Guinea; D019095:Point-of-Care Systems; D013048:Specimen Handling / Q000379:methods*