Age-stratified performance of the cervista HPV 16/18 genotyping test in women with ASC-US cytology

Mark H. Einstein, Francisco A R Garcia, Amy L. Mitchell, Stephen P. Day

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background: The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age. Methods: In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined. Results: The prevalence of cervical intraepithelial neoplasia (CIN) 2+ in subjects positive for HPV 16/18 was 6.6% and 4.1% for women <30 and ≥30 years of age, respectively. The sensitivity of the test was 70.0% (95% CI: 54.6-81.9) and 66.7% (95% CI: 46.7-82.0) in women <30 and ≥30 years, respectively. The NPV was 95.5% (95% CI: 93.4-97.6) in women <30 years and 96.6% (95% CI: 94.8-98.5) in women ≥30 years. Specificity was higher in women ≥30 years (79.9%; 95% CI: 74.9-84.2) than women <30 years (61.9%; 95% CI: 57.1-66.4). The PPV was 15.2% (95% CI: 12.7-19.1) in women <30 years and 21.9% (95% CI: 17.0-30.7) in women ≥30 years. Conclusions: The performance of the Cervista HPV 16/18 genotyping test for predicting ≥CIN 2 is what would be expected across the key ≥CIN 2 age strata. Impact: HPV 16/18 genotyping may help further stratify women with a greater potential to develop cervical cancer.

Original languageEnglish (US)
Pages (from-to)1185-1189
Number of pages5
JournalCancer Epidemiology Biomarkers and Prevention
Volume20
Issue number6
DOIs
StatePublished - Jun 2011

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Papillomaviridae
Cell Biology
Cervical Intraepithelial Neoplasia
Atypical Squamous Cells of the Cervix
Colposcopy

ASJC Scopus subject areas

  • Epidemiology
  • Oncology

Cite this

Age-stratified performance of the cervista HPV 16/18 genotyping test in women with ASC-US cytology. / Einstein, Mark H.; Garcia, Francisco A R; Mitchell, Amy L.; Day, Stephen P.

In: Cancer Epidemiology Biomarkers and Prevention, Vol. 20, No. 6, 06.2011, p. 1185-1189.

Research output: Contribution to journalArticle

Einstein, Mark H. ; Garcia, Francisco A R ; Mitchell, Amy L. ; Day, Stephen P. / Age-stratified performance of the cervista HPV 16/18 genotyping test in women with ASC-US cytology. In: Cancer Epidemiology Biomarkers and Prevention. 2011 ; Vol. 20, No. 6. pp. 1185-1189.
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abstract = "Background: The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age. Methods: In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined. Results: The prevalence of cervical intraepithelial neoplasia (CIN) 2+ in subjects positive for HPV 16/18 was 6.6{\%} and 4.1{\%} for women <30 and ≥30 years of age, respectively. The sensitivity of the test was 70.0{\%} (95{\%} CI: 54.6-81.9) and 66.7{\%} (95{\%} CI: 46.7-82.0) in women <30 and ≥30 years, respectively. The NPV was 95.5{\%} (95{\%} CI: 93.4-97.6) in women <30 years and 96.6{\%} (95{\%} CI: 94.8-98.5) in women ≥30 years. Specificity was higher in women ≥30 years (79.9{\%}; 95{\%} CI: 74.9-84.2) than women <30 years (61.9{\%}; 95{\%} CI: 57.1-66.4). The PPV was 15.2{\%} (95{\%} CI: 12.7-19.1) in women <30 years and 21.9{\%} (95{\%} CI: 17.0-30.7) in women ≥30 years. Conclusions: The performance of the Cervista HPV 16/18 genotyping test for predicting ≥CIN 2 is what would be expected across the key ≥CIN 2 age strata. Impact: HPV 16/18 genotyping may help further stratify women with a greater potential to develop cervical cancer.",
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N2 - Background: The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age. Methods: In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined. Results: The prevalence of cervical intraepithelial neoplasia (CIN) 2+ in subjects positive for HPV 16/18 was 6.6% and 4.1% for women <30 and ≥30 years of age, respectively. The sensitivity of the test was 70.0% (95% CI: 54.6-81.9) and 66.7% (95% CI: 46.7-82.0) in women <30 and ≥30 years, respectively. The NPV was 95.5% (95% CI: 93.4-97.6) in women <30 years and 96.6% (95% CI: 94.8-98.5) in women ≥30 years. Specificity was higher in women ≥30 years (79.9%; 95% CI: 74.9-84.2) than women <30 years (61.9%; 95% CI: 57.1-66.4). The PPV was 15.2% (95% CI: 12.7-19.1) in women <30 years and 21.9% (95% CI: 17.0-30.7) in women ≥30 years. Conclusions: The performance of the Cervista HPV 16/18 genotyping test for predicting ≥CIN 2 is what would be expected across the key ≥CIN 2 age strata. Impact: HPV 16/18 genotyping may help further stratify women with a greater potential to develop cervical cancer.

AB - Background: The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age. Methods: In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined. Results: The prevalence of cervical intraepithelial neoplasia (CIN) 2+ in subjects positive for HPV 16/18 was 6.6% and 4.1% for women <30 and ≥30 years of age, respectively. The sensitivity of the test was 70.0% (95% CI: 54.6-81.9) and 66.7% (95% CI: 46.7-82.0) in women <30 and ≥30 years, respectively. The NPV was 95.5% (95% CI: 93.4-97.6) in women <30 years and 96.6% (95% CI: 94.8-98.5) in women ≥30 years. Specificity was higher in women ≥30 years (79.9%; 95% CI: 74.9-84.2) than women <30 years (61.9%; 95% CI: 57.1-66.4). The PPV was 15.2% (95% CI: 12.7-19.1) in women <30 years and 21.9% (95% CI: 17.0-30.7) in women ≥30 years. Conclusions: The performance of the Cervista HPV 16/18 genotyping test for predicting ≥CIN 2 is what would be expected across the key ≥CIN 2 age strata. Impact: HPV 16/18 genotyping may help further stratify women with a greater potential to develop cervical cancer.

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