HPV Testing by cobas HPV Test in a Population from Catalonia

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Abstract

Background

HPV testing in cervical cancer screening has been proposed as an alternative or complementary to cytology in women older than 30 years. However, adequate clinical sensitivity and specificity are crucial for a new test to be implemented. Hybrid Capture 2 (HC2) has proved good clinical performance in selecting women at risk for high-grade intraepithelial lesions with a high sensitivity and specificity. cobas HPV Test has been recently launched and its performance in different clinical settings needs to be determined.

Objectives

The aim of this study was to evaluate the cobas HPV Test for the detection of cervical HPV infection in a population of women in Catalonia (Spain) using HC2 as a reference.

Materials and Methods

Cervical liquid cytology samples from 958 women have been studied. Sensitivity was analyzed in 60 samples from patients with a high-grade intraepithelial lesion (≥CIN2) on histology and specificity was determined in 898 samples from women with no ≥CIN2. All cases had HC2 and cobas HPV Test performed. Statistical analyses of sensitivity, specificity and comparison between HC2 and cobas HPV Test by a non-inferiority test were applied.

Results

Sensitivity of HC2 and cobas HPV Test for detecting ≥CIN2 proved identical (98.3%) while specificity was 85.3% and 86.2% respectively. The non-inferiority test demonstrated that cobas HPV Test surpassed 90% sensitivity and 98% specificity of HC2.

Conclusion

The cobas HPV Test results fulfilled sensitivity and specificity requirements for HPV based cervical cancer screening and for the triage of minor cytological abnormalities, allowing its introduction in clinical settings.

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Most cited references 10

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Overview of the European and North American studies on HPV testing in primary cervical cancer screening.

Jack Cuzick, Christine Clavel, Karl-Ulrich Petry … (2006)

Several studies suggest that HPV testing is more sensitive than cytology in primary cervical screening. These studies had different designs and were reported in different ways. Individual patient data were collected for all European and North American studies in which cytology was routinely performed and HPV testing was included as an additional parallel test. More than 60,000 women were included. The sensitivity and specificity of HPV testing were compared with routine cytology, both overall and for ages <35, 35-49 and 50+. The age-specific prevalence of high risk HPV (hr-HPV) was also analysed. HPV testing was substantially more sensitive in detecting CIN2+ than cytology (96.1% vs. 53.0%) but less specific (90.7% vs. 96.3%). The sensitivity of HPV testing was similar in all studies carried out in different areas of Europe and North America, whereas the sensitivity of cytology was highly variable. HPV sensitivity was uniformly high at all ages, whereas the sensitivity of cytology was substantially better in women over the age of 50 than in younger women (79.3% vs. 59.6%). The specificity of both tests increased with age. Positivity rates for HPV testing in women without high-grade CIN were region dependent. These results support the use of HPV testing as the sole primary screening test, with cytology reserved for women who test HPV positive. Large demonstration projects are needed to fully evaluate this strategy. Copyright 2006 Wiley-Liss, Inc.

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Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer.

Marie-Hélène Mayrand, Eliane Duarte-Franco, Isabel Rodrigues … (2007)

To determine whether testing for DNA of oncogenic human papillomaviruses (HPV) is superior to the Papanicolaou (Pap) test for cervical-cancer screening, we conducted a randomized trial comparing the two methods. We compared HPV testing, using an assay approved by the Food and Drug Administration, with conventional Pap testing as a screening method to identify high-grade cervical intraepithelial neoplasia in women ages 30 to 69 years in Montreal and St. John's, Canada. Women with abnormal Pap test results or a positive HPV test (at least 1 pg of high-risk HPV DNA per milliliter) underwent colposcopy and biopsy, as did a random sample of women with negative tests. Sensitivity and specificity estimates were corrected for verification bias. A total of 10,154 women were randomly assigned to testing. Both tests were performed on all women in a randomly assigned sequence at the same session. The sensitivity of HPV testing for cervical intraepithelial neoplasia of grade 2 or 3 was 94.6% (95% confidence interval [CI], 84.2 to 100), whereas the sensitivity of Pap testing was 55.4% (95% CI, 33.6 to 77.2; P=0.01). The specificity was 94.1% (95% CI, 93.4 to 94.8) for HPV testing and 96.8% (95% CI, 96.3 to 97.3; P<0.001) for Pap testing. Performance was unaffected by the sequence of the tests. The sensitivity of both tests used together was 100%, and the specificity was 92.5%. Triage procedures for Pap or HPV testing resulted in fewer referrals for colposcopy than did either test alone but were less sensitive. No adverse events were reported. As compared with Pap testing, HPV testing has greater sensitivity for the detection of cervical intraepithelial neoplasia. (Current Controlled Trials number, ISRCTN57612064 [controlled-trials.com].). Copyright 2007 Massachusetts Medical Society.

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Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study

Joakim Dillner, Matejka Rebolj, Philippe Birembaut … (2008)

Objective To obtain large scale and generalisable data on the long term predictive value of cytology and human papillomavirus (HPV) testing for development of cervical intraepithelial neoplasia grade 3 or cancer (CIN3+). Design Multinational cohort study with joint database analysis. Setting Seven primary HPV screening studies in six European countries. Participants 24 295 women attending cervical screening enrolled into HPV screening trials who had at least one cervical cytology or histopathology examination during follow-up. Main outcome measure Long term cumulative incidence of CIN3+. Results The cumulative incidence rate of CIN3+ after six years was considerably lower among women negative for HPV at baseline (0.27%, 95% confidence interval 0.12% to 0.45%) than among women with negative results on cytology (0.97%, 0.53% to 1.34%)). By comparison, the cumulative incidence rate for women with negative cytology results at the most commonly recommended screening interval in Europe (three years) was 0.51% (0.23% to 0.77%). The cumulative incidence rate among women with negative cytology results who were positive for HPV increased continuously over time, reaching 10% at six years, whereas the rate among women with positive cytology results who were negative for HPV remained below 3%. Conclusions A consistently low six year cumulative incidence rate of CIN3+ among women negative for HPV suggests that cervical screening strategies in which women are screened for HPV every six years are safe and effective.

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Author and article information

Contributors

Michael Scheurer: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2013

Publication date (Electronic): 6 March 2013

Volume: 8

Issue: 3

Electronic Location Identifier: e58153

Affiliations

[1 ]Department of Pathology, Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain

[2 ]Consulting Service on Methodology for Biomedical Research, IMIM, Barcelona, Spain

[3 ]Clinical Unit of Infectious Diseases and Microbiology, Hospital de Valme, Sevilla, Spain

Baylor College of Medicine, United States of America

Author notes

* E-mail: blloveras@ 123456parcdesalutmar.cat

Competing Interests: Roche has paid travel expenses and meeting registration fees for Dr. B. Lloveras. Silvia Gomez is a Ph.D. student at Hospital del Mar and works for Roche Diagnostics s.l. in Application Customer Support. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

Conceived and designed the experiments: BL FA SG BB SS. Performed the experiments: SG BB MM MP JCP. Analyzed the data: SM. Wrote the paper: BL SG FA BB.

Article

Publisher ID: PONE-D-12-22458

DOI: 10.1371/journal.pone.0058153

PMC ID: 3590124

PubMed ID: 23483984

SO-VID: fb233cde-2d1e-46c7-963a-a7f8b44efd61

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 29 July 2012

Date accepted : 3 February 2013

Page count

Pages: 5

Funding

This work was supported by grants from Instituto de Salud Carlos III FEDER 23 (RD09/0076/00036) and the “Xarxa de Bancs de tumors sponsored by Pla 24 Director d’Oncologia de Catalunya (XBTC). Roche Diagnostics has provided reagents for this work. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. No current external funding sources for this study.

HPV Testing by cobas HPV Test in a Population from Catalonia

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Abstract

Background

Objectives

Materials and Methods

Results

Conclusion

Related collections

HIV Self-Testing

Most cited references 10

Overview of the European and North American studies on HPV testing in primary cervical cancer screening.

Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer.

Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study

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