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. 2019 Sep;121(6):455-463.
doi: 10.1038/s41416-019-0547-x. Epub 2019 Aug 14.

16/18 genotyping in triage of persistent human papillomavirus infections with negative cytology in the English cervical screening pilot

Matejka Rebolj  1 , Adam R Brentnall  2 , Christopher Mathews  3 , Karin Denton  4 , Miles Holbrook  5 , Tanya Levine  6 , Alexandra Sargent  5 , John Smith  7 , John Tidy  8 , Xenia Tyler  9 , Henry Kitchener  10 ; HPV Pilot Steering Group
Affiliations

16/18 genotyping in triage of persistent human papillomavirus infections with negative cytology in the English cervical screening pilot

Matejka Rebolj et al. Br J Cancer. 2019 Sep.

Abstract

Background: In the English pilot of primary cervical screening with high-risk human papillomavirus (HR-HPV), we exploited natural viral clearance over 24 months to minimise unnecessary referral of HR-HPV+ women with negative cytology. Three laboratories were permitted to use 16/18 genotyping to select women for referral at 12-month recall. We estimated the clinical impact of this early genotyping referral.

Methods: The observed numbers of women referred to colposcopy and with detected high-grade cervical intraepithelial neoplasia (CIN2+), and of women who did not attend early recall in the three laboratories were compared with those estimated to represent a situation without an early genotyping referral. The 95% confidence intervals (CI) for the differences between the protocols were calculated by using a parametric bootstrap.

Results: Amongst 127,238 screened women, 16,097 (13%) had HR-HPV infections. The genotyping protocol required 5.9% (95% CI: 4.4-7.7) additional colposcopies and led to a detection of 1.2% additional CIN2+ (95% CI: 0.6-2.0), while 2.3% (95% CI: 2.1-2.5) fewer HR-HPV+/cytology- women did not attend the early recall compared with the non-genotyping protocol.

Conclusions: In a screening programme with high quality of triage cytology and high adherence to early recall,16/18 genotyping of persistent HPV infections does not substantially increase CIN2+ detection.

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Conflict of interest statement

M.R.: PHE provided financing for the epidemiological evaluation; attended meetings with various HPV assay manufacturers; fee for lecture from Hologic paid to employer. C.M.: Partly funded by PHE that provided financing for the epidemiological evaluation. K.D. has received speaker fees and travel expenses to attend meetings from Hologic. M.H., T.L., X.T.: PHE provided funding to support the NHS screening laboratory activity for the pilot. A.S.: Attended meetings with HPV assay manufacturers; speaker fees from Roche; travel and accommodation from Roche for training and from Abbott for user group meeting; Roche, Abbott, Hologic, Becton Dickinson and Cepheid provided kits for assay validation purposes; PHE provided funding to support the NHS screening laboratory activity for the pilot. J.S.: Personal speaker bureau fees from Beckton Dickinson; personal medical advisory board fees from Zilico. J.T.: Fees for lectures from Roche, Qiagen and Hologic; conference registration, accommodation and travel from Sanofi Pasteur; consultancy fees and shareholder in Zilico; patent for electrical impedance spectroscopy in detection of cervical intraepithelial neoplasia with Zilico. H.K.: Chair of the Advisory Committee for Cervical Screening (PHE), but the views expressed in this manuscript are those of the author and do not represent the view of PHE. A.R.B. declares no competing interests.

Figures

Fig. 1
Fig. 1
Screening outcomes including colposcopies and detection of CIN2+ outside of the recommended protocol. Screening was undertaken between May 2013 and December 2014, follow-up data were retrieved until May 2017. a Women with HPV 16/18 infections at baseline. b Women with HR-HPV infections other than HPV 16/18 at baseline. CIN cervical intraepithelial neoplasia, Colpo colposcopy, HPV human papillomavirus, R12 early recall at 12 months, R24 early recall at 24 months, Recomm. recommended
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