Clinical validation of the Cervista® HPV HR and 16/18 genotyping tests for use in women with ASC-US cytology

Mark H. Einstein, Mark G. Martens, Francisco A.R. Garcia, Daron Gale Ferris, Amy L. Mitchell, Stephen P. Day, Marilyn C. Olson

Research output: Contribution to journalArticle

83 Citations (Scopus)

Abstract

Objective. High-risk (HR) human papillomavirus (HPV) testing is important in cervical cancer screening for triage to colposcopy. This study evaluated the clinical performance of the Cervista- HPV HR and 16/18 genotyping tests for detection of HPV in cervical cytology specimens. Methods. The tests were prospectively evaluated in a multicenter clinical study. DNA was extracted from approximately 4000 residual liquid-based cytology specimens collected during routine liquid-based Papanicolaou tests at standard of care visits and was assessed for the presence of HR HPV and/or HPV types 16 and 18. All women with cytology results of atypical squamous cells of undetermined significance (ASC-US) or greater underwent colposcopic examination and biopsies were collected. Test results were compared with local colposcopy and histology results from a central pathology review panel. Results. There were 1347 subjects with complete data sets of cytology, HR HPV, colposcopy, and histology included in the analysis of the HPV HR test. Sensitivity of the HPV HR test for detection of cervical intraepithelial neoplasia (CIN) 2+ among women with ASC-US cytology was 92.8% (95% confidence interval [CI]: 84.1-96.9) and the negative predictive value (NPV) was 99.1% (95% CI: 98.1-99.6). Sensitivity for detection of ≥CIN 3 in women with ASC-US was 100% (95% CI: 85.1-100) and the NPV was 100% (95% CI: 99.4-100). The specificity of the test for detection of ≥CIN 2 and ≥CIN 3 was 44.2% (95% CI: 41.5-46.9) and 43% (95% CI: 40.3-45.7), respectively. The HPV 16/18 genotyping test also performed as expected in women with ASC-US cytology who were positive for HR HPV. Conclusion. The Cervista® HPV HR test can be clinically used for detecting HR HPV types in conjunction with cervical cytology for use in triage of women with ASC-US cytology during routine cervical cancer screening.

Original languageEnglish (US)
Pages (from-to)116-122
Number of pages7
JournalGynecologic Oncology
Volume118
Issue number2
DOIs
StatePublished - Aug 1 2010

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Cell Biology
Cervical Intraepithelial Neoplasia
Confidence Intervals
Colposcopy
Human papillomavirus 18
Human papillomavirus 16
Triage
Early Detection of Cancer
Uterine Cervical Neoplasms
Histology
Atypical Squamous Cells of the Cervix
Papanicolaou Test
Standard of Care
Multicenter Studies
Pathology
Biopsy
DNA

Keywords

  • ASC-US
  • Colposcopy
  • Genotyping
  • High-risk HPV
  • Triage

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Cite this

Clinical validation of the Cervista® HPV HR and 16/18 genotyping tests for use in women with ASC-US cytology. / Einstein, Mark H.; Martens, Mark G.; Garcia, Francisco A.R.; Ferris, Daron Gale; Mitchell, Amy L.; Day, Stephen P.; Olson, Marilyn C.

In: Gynecologic Oncology, Vol. 118, No. 2, 01.08.2010, p. 116-122.

Research output: Contribution to journalArticle

Einstein, Mark H. ; Martens, Mark G. ; Garcia, Francisco A.R. ; Ferris, Daron Gale ; Mitchell, Amy L. ; Day, Stephen P. ; Olson, Marilyn C. / Clinical validation of the Cervista® HPV HR and 16/18 genotyping tests for use in women with ASC-US cytology. In: Gynecologic Oncology. 2010 ; Vol. 118, No. 2. pp. 116-122.
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abstract = "Objective. High-risk (HR) human papillomavirus (HPV) testing is important in cervical cancer screening for triage to colposcopy. This study evaluated the clinical performance of the Cervista- HPV HR and 16/18 genotyping tests for detection of HPV in cervical cytology specimens. Methods. The tests were prospectively evaluated in a multicenter clinical study. DNA was extracted from approximately 4000 residual liquid-based cytology specimens collected during routine liquid-based Papanicolaou tests at standard of care visits and was assessed for the presence of HR HPV and/or HPV types 16 and 18. All women with cytology results of atypical squamous cells of undetermined significance (ASC-US) or greater underwent colposcopic examination and biopsies were collected. Test results were compared with local colposcopy and histology results from a central pathology review panel. Results. There were 1347 subjects with complete data sets of cytology, HR HPV, colposcopy, and histology included in the analysis of the HPV HR test. Sensitivity of the HPV HR test for detection of cervical intraepithelial neoplasia (CIN) 2+ among women with ASC-US cytology was 92.8{\%} (95{\%} confidence interval [CI]: 84.1-96.9) and the negative predictive value (NPV) was 99.1{\%} (95{\%} CI: 98.1-99.6). Sensitivity for detection of ≥CIN 3 in women with ASC-US was 100{\%} (95{\%} CI: 85.1-100) and the NPV was 100{\%} (95{\%} CI: 99.4-100). The specificity of the test for detection of ≥CIN 2 and ≥CIN 3 was 44.2{\%} (95{\%} CI: 41.5-46.9) and 43{\%} (95{\%} CI: 40.3-45.7), respectively. The HPV 16/18 genotyping test also performed as expected in women with ASC-US cytology who were positive for HR HPV. Conclusion. The Cervista{\circledR} HPV HR test can be clinically used for detecting HR HPV types in conjunction with cervical cytology for use in triage of women with ASC-US cytology during routine cervical cancer screening.",
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AU - Ferris, Daron Gale

AU - Mitchell, Amy L.

AU - Day, Stephen P.

AU - Olson, Marilyn C.

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N2 - Objective. High-risk (HR) human papillomavirus (HPV) testing is important in cervical cancer screening for triage to colposcopy. This study evaluated the clinical performance of the Cervista- HPV HR and 16/18 genotyping tests for detection of HPV in cervical cytology specimens. Methods. The tests were prospectively evaluated in a multicenter clinical study. DNA was extracted from approximately 4000 residual liquid-based cytology specimens collected during routine liquid-based Papanicolaou tests at standard of care visits and was assessed for the presence of HR HPV and/or HPV types 16 and 18. All women with cytology results of atypical squamous cells of undetermined significance (ASC-US) or greater underwent colposcopic examination and biopsies were collected. Test results were compared with local colposcopy and histology results from a central pathology review panel. Results. There were 1347 subjects with complete data sets of cytology, HR HPV, colposcopy, and histology included in the analysis of the HPV HR test. Sensitivity of the HPV HR test for detection of cervical intraepithelial neoplasia (CIN) 2+ among women with ASC-US cytology was 92.8% (95% confidence interval [CI]: 84.1-96.9) and the negative predictive value (NPV) was 99.1% (95% CI: 98.1-99.6). Sensitivity for detection of ≥CIN 3 in women with ASC-US was 100% (95% CI: 85.1-100) and the NPV was 100% (95% CI: 99.4-100). The specificity of the test for detection of ≥CIN 2 and ≥CIN 3 was 44.2% (95% CI: 41.5-46.9) and 43% (95% CI: 40.3-45.7), respectively. The HPV 16/18 genotyping test also performed as expected in women with ASC-US cytology who were positive for HR HPV. Conclusion. The Cervista® HPV HR test can be clinically used for detecting HR HPV types in conjunction with cervical cytology for use in triage of women with ASC-US cytology during routine cervical cancer screening.

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