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. 2015 Mar 20;10(3):e0119755.
doi: 10.1371/journal.pone.0119755. eCollection 2015.

Primary screening for cervical cancer based on high-risk human papillomavirus (HPV) detection and HPV 16 and HPV 18 genotyping, in comparison to cytology

Theodoros Agorastos  1 , Kimon Chatzistamatiou  1 , Taxiarchis Katsamagkas  1 , George Koliopoulos  2 , Alexandros Daponte  3 , Theocharis Constantinidis  4 , Theodoros C Constantinidis  5 ; HERMES study group
Collaborators, Affiliations

Primary screening for cervical cancer based on high-risk human papillomavirus (HPV) detection and HPV 16 and HPV 18 genotyping, in comparison to cytology

Theodoros Agorastos et al. PLoS One. .

Abstract

Objectives: The objective of the present study is to assess the performance of a high-risk human papillomavirus (HR-HPV) DNA test with individual HPV-16/HPV-18 genotyping as a method for primary cervical cancer screening compared with liquid-based cytology (LBC) in a population of Greek women taking part in routine cervical cancer screening.

Methods: The study, conducted by the "HEllenic Real life Multicentric cErvical Screening" (HERMES) study group, involved the recruitment of 4,009 women, aged 25-55, who took part in routine cervical screening at nine Gynecology Departments in Greece. At first visit cervical specimens were collected for LBC and HPV testing using the Roche Cobas 4800 system. Women found positive for either cytology or HPV were referred for colposcopy, whereas women negative for both tests will be retested after three years. The study is ongoing and the results of the first screening round are reported herein.

Results: Valid results for cytology and HPV testing were obtained for 3,993 women. The overall prevalence of HR-HPV was 12.7%, of HPV-16 2.7% and of HPV-18 1.4%. Of those referred for colposcopy, cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was detected in 41 women (1.07%). At the threshold of CIN2+, cytology [atypical squamous cells of undetermined significance (ASC-US) or worse] and HPV testing showed a sensitivity of 53.7% and 100% respectively, without change between age groups. Cytology and HPV testing showed specificity of 96.8% and 90.3% respectively, which was increased in older women (≥30) in comparison to younger ones (25-29). Genotyping for HPV16/18 had similar accuracy to cytology for the detection of CIN2+ (sensitivity: 58.5%; specificity 97.5%) as well as for triage to colposcopy (sensitivity: 58.5% vs 53.7% for cytology).

Conclusion: HPV testing has much better sensitivity than cytology to identify high-grade cervical lesions with slightly lower specificity. HPV testing with individual HPV-16/HPV-18 genotyping could represent a more accurate methodology for primary cervical cancer screening in comparison to liquid-based cytology, especially in older women.

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Conflict of interest statement

Competing Interests: The authors have read the journal's policy and the authors of this manuscript have the following competing interests: KC and TK had their travel expenses and fees for two Congresses (EUROGIN 2012 and EUROGIN 2013) covered by Roche Diagnostics. GK, AD, TC and TCC have declared that no competing interests exist. TA has performed research trials partially supported by Vianex/Sanofi Pasteur MSD and has had travel expenses for conferences/meetings/symposia occasionally Cover Letter covered by either Vianex/Sanofi Pasteur MSD, GlaxoSmithKline and Roche Diagnostics. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials. All the authors declare no competing interests related to the commercial funder, Roche Diagnostics, concerning employment, consultancy, patents, products in development, marketed products etc.

Figures

Fig 1
Fig 1. Flowchart of the study design.
This article presents the results of the first screening round (cross-sectional phase) of a longitudinal screening test accuracy study.
Fig 2
Fig 2. Flowchart for the liquid-based cytology and HPV DNA test performed on the study population.
See this image and copyright information in PMC

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