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P10.02 Field evaluation of the xpert hpv test for the detection of human papillomavirus infection in women using self-collected vaginal compared to clinician-collected cervical specimens
  1. A Vallely1,2,
  2. P Toliman2,
  3. S Tabrizi3,
  4. SG Badman1,
  5. Z Kombati4,
  6. J Gabuzzi2,
  7. J Allan2,
  8. G Munnull2,
  9. S Silim2,
  10. C Ryan5,
  11. LM Vallely2,
  12. A Kelly-Hanku2,6,
  13. H Wand1,
  14. GDL Mola7,
  15. P Siba2,
  16. R Guy1,
  17. JM Kaldor1
  1. 1The Kirby Institute, University of New South Wales, Sydney, Australia
  2. 2Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea
  3. 3Molecular Microbiology Laboratory, The Royal Women’s Hospital, Melbourne, Australia
  4. 4Pathology Department, Mt Hagen Hospital, Western Highlands Province, Papua New Guinea
  5. 5The Burnet Institute, Melbourne, Australia
  6. 6School of Public Health & Community Medicine, UNSW Australia
  7. 7Department of Obstetrics & Gynaecology, School of Medicine and Health Sciences, University of Papua New Guinea, National Capital District, Papua New Guinea

Abstract

Background The Cepheid Xpert® HPV Test has high sensitivity and specificity for the detection of HPV infection in women compared to the Roche cobas 4800 HPV assay using cervical specimens. In many high-burden, low-resource countries it will not be feasible to achieve high cervical screening coverage using HPV-DNA technologies that require clinician-collected samples. We are conducting the first evaluation of self-collected vaginal specimens compared to clinician-collected cervical specimens for the detection of HPV infection using the Xpert® HPV Test. This study is being conducted in Papua New Guinea, which has among the highest rates of cervical cancer globally, with an age-standardised incidence of 23.7/100,000 compared to 5.0/100,000 in Australia and New Zealand.

Methods Women aged 30–54 years attending two Well Woman Clinics are invited to participate and following informed consent procedures, complete a short interview, clinical examination, and provide self-collected and clinician-collected cytobrush specimens for clinic-based HPV testing. Women are given their cervical test result the same day. Those with a positive HPV test and a positive examination on visual inspection of the cervix with acetic acid are offered same-day cervical cryotherapy.

Results A total of 313 women were recruited to end-Feb 2015. There was 94.2% overall percentage agreement (OPA) between vaginal and cervical tests for all high-risk HPV (hrHPV) types; 100% OPA for HPV-16; and 99.7% OPA for HPV 18/45. Based on cervical test results, the prevalence of HPV-16 was 4.2% (13/313); HPV 18/45 was 1.6% (5/313); and other hrHPV, 11.8% (37/313). Overall, 15.7% (49/313) of participants had one or more hrHPV infection.

Conclusion Preliminary results suggest that self-collected vaginal specimens compare favourably to clinician-collected cervical specimens for the detection of HPV infection using the Xpert® HPV Test. If confirmed, this finding is likely to have significant implications for future HPV-based cervical screening programs in high-burden, low-resource settings worldwide.

Disclosure of interest statement Nothing to Disclose.

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