The role of human papillomavirus genotyping in cervical cancer screening: A large-scale evaluation of the cobas HPV test

Mark Schiffman, Sean Boyle, Tina Raine-Bennett, Hormuzd A. Katki, Julia C. Gage, Nicolas Wentzensen, Janet R. Kornegay, Raymond Apple, Carrie Aldrich, Henry A. Erlich, Thanh Tam, Brian Befano, Robert D. Burk, Philip E. Castle

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Abstract

Background: The cobas HPV Test ("cobas"; Roche Molecular Systems) detects HPV16 and HPV18 individually, and a pool of 12 other high-risk (HR) HPV types. The test is approved for (i) atypical squamous cells of undetermined significance (ASC-US) triage to determine need for colposcopy, (ii) combined screening with cytology ("cotesting"), and (iii) primary HPV screening. Methods: To assess the possible value of HPV16/18 typing, >17,000 specimens from a longitudinal cohort study of initially HPV-positive women (HC2, Qiagen) were retested with cobas. To study accuracy, cobas genotyping results were compared with those of an established method, the Linear Array HPV Genotyping Test (LA, Roche Molecular Systems). Clinical value of the typing strategy was evaluated by linking the cobas results (supplemented by other available typing results) to 3-year cumulative risks of CIN3+. Results: Grouped hierarchically (HPV16, else HPV18, else other HR types, else negative), the κ statistic for agreement between cobas and LA was 0.86 [95% confidence interval (CI), 0.86-0.87]. In all three scenarios, HPV16-positive women were at much higher 3-year risk of CIN3+ than HPV16-negative women: women ages 21 and older with ASC-US (14.5%; 95% CI, 13.5%- 15.5% vs. 3.5%;95% CI, 3.3-3.6); women ages 30 years and older that were HPV-positive cytology-negative (10.3%; 95% CI, 9.6- 11.1 vs. 2.3%; 95% CI, 2.2-2.4); and all women 25 years and older that were HPV-positive (18.5%; 95% CI, 17.8-19.2 vs. 4.3%; 95% CI, 4.2-4.4). Conclusion: The cobas and LA results show excellent agreement. The data support HPV16 typing. Impact: HPV16 typing is useful in the management of HPVpositive/cytology-negative women in cotesting, of all HPV-positive women in primary HPV testing, and perhaps in the management of HPV-positivewomen withASC-US.

Original languageEnglish (US)
Pages (from-to)1304-1310
Number of pages7
JournalCancer Epidemiology Biomarkers and Prevention
Volume24
Issue number9
DOIs
StatePublished - Sep 1 2015

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Early Detection of Cancer
Uterine Cervical Neoplasms
Confidence Intervals
Cell Biology
Colposcopy
Triage
Longitudinal Studies
Cohort Studies

ASJC Scopus subject areas

  • Epidemiology
  • Oncology

Cite this

The role of human papillomavirus genotyping in cervical cancer screening : A large-scale evaluation of the cobas HPV test. / Schiffman, Mark; Boyle, Sean; Raine-Bennett, Tina; Katki, Hormuzd A.; Gage, Julia C.; Wentzensen, Nicolas; Kornegay, Janet R.; Apple, Raymond; Aldrich, Carrie; Erlich, Henry A.; Tam, Thanh; Befano, Brian; Burk, Robert D.; Castle, Philip E.

In: Cancer Epidemiology Biomarkers and Prevention, Vol. 24, No. 9, 01.09.2015, p. 1304-1310.

Research output: Contribution to journalArticle

Schiffman, M, Boyle, S, Raine-Bennett, T, Katki, HA, Gage, JC, Wentzensen, N, Kornegay, JR, Apple, R, Aldrich, C, Erlich, HA, Tam, T, Befano, B, Burk, RD & Castle, PE 2015, 'The role of human papillomavirus genotyping in cervical cancer screening: A large-scale evaluation of the cobas HPV test', Cancer Epidemiology Biomarkers and Prevention, vol. 24, no. 9, pp. 1304-1310. https://doi.org/10.1158/1055-9965.EPI-14-1353
Schiffman, Mark ; Boyle, Sean ; Raine-Bennett, Tina ; Katki, Hormuzd A. ; Gage, Julia C. ; Wentzensen, Nicolas ; Kornegay, Janet R. ; Apple, Raymond ; Aldrich, Carrie ; Erlich, Henry A. ; Tam, Thanh ; Befano, Brian ; Burk, Robert D. ; Castle, Philip E. / The role of human papillomavirus genotyping in cervical cancer screening : A large-scale evaluation of the cobas HPV test. In: Cancer Epidemiology Biomarkers and Prevention. 2015 ; Vol. 24, No. 9. pp. 1304-1310.
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abstract = "Background: The cobas HPV Test ({"}cobas{"}; Roche Molecular Systems) detects HPV16 and HPV18 individually, and a pool of 12 other high-risk (HR) HPV types. The test is approved for (i) atypical squamous cells of undetermined significance (ASC-US) triage to determine need for colposcopy, (ii) combined screening with cytology ({"}cotesting{"}), and (iii) primary HPV screening. Methods: To assess the possible value of HPV16/18 typing, >17,000 specimens from a longitudinal cohort study of initially HPV-positive women (HC2, Qiagen) were retested with cobas. To study accuracy, cobas genotyping results were compared with those of an established method, the Linear Array HPV Genotyping Test (LA, Roche Molecular Systems). Clinical value of the typing strategy was evaluated by linking the cobas results (supplemented by other available typing results) to 3-year cumulative risks of CIN3+. Results: Grouped hierarchically (HPV16, else HPV18, else other HR types, else negative), the κ statistic for agreement between cobas and LA was 0.86 [95{\%} confidence interval (CI), 0.86-0.87]. In all three scenarios, HPV16-positive women were at much higher 3-year risk of CIN3+ than HPV16-negative women: women ages 21 and older with ASC-US (14.5{\%}; 95{\%} CI, 13.5{\%}- 15.5{\%} vs. 3.5{\%};95{\%} CI, 3.3-3.6); women ages 30 years and older that were HPV-positive cytology-negative (10.3{\%}; 95{\%} CI, 9.6- 11.1 vs. 2.3{\%}; 95{\%} CI, 2.2-2.4); and all women 25 years and older that were HPV-positive (18.5{\%}; 95{\%} CI, 17.8-19.2 vs. 4.3{\%}; 95{\%} CI, 4.2-4.4). Conclusion: The cobas and LA results show excellent agreement. The data support HPV16 typing. Impact: HPV16 typing is useful in the management of HPVpositive/cytology-negative women in cotesting, of all HPV-positive women in primary HPV testing, and perhaps in the management of HPV-positivewomen withASC-US.",
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T1 - The role of human papillomavirus genotyping in cervical cancer screening

T2 - A large-scale evaluation of the cobas HPV test

AU - Schiffman, Mark

AU - Boyle, Sean

AU - Raine-Bennett, Tina

AU - Katki, Hormuzd A.

AU - Gage, Julia C.

AU - Wentzensen, Nicolas

AU - Kornegay, Janet R.

AU - Apple, Raymond

AU - Aldrich, Carrie

AU - Erlich, Henry A.

AU - Tam, Thanh

AU - Befano, Brian

AU - Burk, Robert D.

AU - Castle, Philip E.

PY - 2015/9/1

Y1 - 2015/9/1

N2 - Background: The cobas HPV Test ("cobas"; Roche Molecular Systems) detects HPV16 and HPV18 individually, and a pool of 12 other high-risk (HR) HPV types. The test is approved for (i) atypical squamous cells of undetermined significance (ASC-US) triage to determine need for colposcopy, (ii) combined screening with cytology ("cotesting"), and (iii) primary HPV screening. Methods: To assess the possible value of HPV16/18 typing, >17,000 specimens from a longitudinal cohort study of initially HPV-positive women (HC2, Qiagen) were retested with cobas. To study accuracy, cobas genotyping results were compared with those of an established method, the Linear Array HPV Genotyping Test (LA, Roche Molecular Systems). Clinical value of the typing strategy was evaluated by linking the cobas results (supplemented by other available typing results) to 3-year cumulative risks of CIN3+. Results: Grouped hierarchically (HPV16, else HPV18, else other HR types, else negative), the κ statistic for agreement between cobas and LA was 0.86 [95% confidence interval (CI), 0.86-0.87]. In all three scenarios, HPV16-positive women were at much higher 3-year risk of CIN3+ than HPV16-negative women: women ages 21 and older with ASC-US (14.5%; 95% CI, 13.5%- 15.5% vs. 3.5%;95% CI, 3.3-3.6); women ages 30 years and older that were HPV-positive cytology-negative (10.3%; 95% CI, 9.6- 11.1 vs. 2.3%; 95% CI, 2.2-2.4); and all women 25 years and older that were HPV-positive (18.5%; 95% CI, 17.8-19.2 vs. 4.3%; 95% CI, 4.2-4.4). Conclusion: The cobas and LA results show excellent agreement. The data support HPV16 typing. Impact: HPV16 typing is useful in the management of HPVpositive/cytology-negative women in cotesting, of all HPV-positive women in primary HPV testing, and perhaps in the management of HPV-positivewomen withASC-US.

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