Reflex human papillomavirus DNA testing on residual liquid-based (TPPT™) cervical samples

Focus on age-stratified clinical performance

Venetia Rumnong Sarode, Claudia Werner, Rita Gander, Barbara Foster, Amy Fulmer, M. Hossein Saboorian, Raheela Ashfaq

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

BACKGROUND. Liquid-based ThinPrep technology has made reflex human papillomavirus (HPV) DNA testing possible. In the current study, the clinical performance of reflex HPV testing as an adjunct to routine ThinPrep testing (TPPT) and the impact of age on various test parameters in a predominantly high-risk, minority population were evaluated retrospectively. METHODS. Reflex HPV testing was performed in 2114 women with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) cytology, using probes for low-risk (LR) and high-risk (HR) HPV types. Six hundred thirty women underwent subsequent biopsies with which HPV testing results were correlated. RESULTS. Approximately 86% of the patients were Hispanic and African-American and 12% were white. Of the younger women (ages 14-29 years), 81% were positive for HR types versus 50% in the older women (ages 30-77 years) (P < 0.0001). In women with ASCUS, 47% were found to be positive for HR types versus 78% of women with LSIL. The percentage of histologic high-grade lesions was 24% in younger patients versus 17% in older patients. Overall, 91% of high-grade lesions were positive for HPV DNA (HR-positive = 89% and LR-positive = 2%), and 9% were negative for both types. The sensitivities and specificities in "younger" versus "older" women were 92% (95% confidence interval [95% CI], 89-95%) and 22%% (95% CI, 17-26%), respectively, versus 84% (95% CI, 77-90%) and 59% (95% CI, 53-65%), respectively. CONCLUSIONS. The results of the current study demonstrate that reflex HPV testing performed in a routine clinical practice helps to identify the majority of women with high-grade disease. However, testing may be more beneficial in older women (age ≥ 30 years) with ASCUS. Strategy using out-of-vial reflex testing is more cost-effective and sensitive than referring all women for colposcopies.

Original languageEnglish (US)
Pages (from-to)149-155
Number of pages7
JournalCancer
Volume99
Issue number3
DOIs
StatePublished - Jun 25 2003

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Reflex
DNA
Confidence Intervals
Colposcopy
Hispanic Americans
African Americans
Cell Biology
Technology
Biopsy
Costs and Cost Analysis
Sensitivity and Specificity
Population

Keywords

  • Age and race
  • Atypical squamous cells of undetermined significance (ASCUS)
  • Human papillomavirus (HPV)
  • Hybrid capture (HC II)
  • Liquid-based
  • Routine ThinPrep testing (TPPT)
  • Triage

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Reflex human papillomavirus DNA testing on residual liquid-based (TPPT™) cervical samples : Focus on age-stratified clinical performance. / Sarode, Venetia Rumnong; Werner, Claudia; Gander, Rita; Foster, Barbara; Fulmer, Amy; Saboorian, M. Hossein; Ashfaq, Raheela.

In: Cancer, Vol. 99, No. 3, 25.06.2003, p. 149-155.

Research output: Contribution to journalArticle

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title = "Reflex human papillomavirus DNA testing on residual liquid-based (TPPT™) cervical samples: Focus on age-stratified clinical performance",
abstract = "BACKGROUND. Liquid-based ThinPrep technology has made reflex human papillomavirus (HPV) DNA testing possible. In the current study, the clinical performance of reflex HPV testing as an adjunct to routine ThinPrep testing (TPPT) and the impact of age on various test parameters in a predominantly high-risk, minority population were evaluated retrospectively. METHODS. Reflex HPV testing was performed in 2114 women with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) cytology, using probes for low-risk (LR) and high-risk (HR) HPV types. Six hundred thirty women underwent subsequent biopsies with which HPV testing results were correlated. RESULTS. Approximately 86{\%} of the patients were Hispanic and African-American and 12{\%} were white. Of the younger women (ages 14-29 years), 81{\%} were positive for HR types versus 50{\%} in the older women (ages 30-77 years) (P < 0.0001). In women with ASCUS, 47{\%} were found to be positive for HR types versus 78{\%} of women with LSIL. The percentage of histologic high-grade lesions was 24{\%} in younger patients versus 17{\%} in older patients. Overall, 91{\%} of high-grade lesions were positive for HPV DNA (HR-positive = 89{\%} and LR-positive = 2{\%}), and 9{\%} were negative for both types. The sensitivities and specificities in {"}younger{"} versus {"}older{"} women were 92{\%} (95{\%} confidence interval [95{\%} CI], 89-95{\%}) and 22{\%}{\%} (95{\%} CI, 17-26{\%}), respectively, versus 84{\%} (95{\%} CI, 77-90{\%}) and 59{\%} (95{\%} CI, 53-65{\%}), respectively. CONCLUSIONS. The results of the current study demonstrate that reflex HPV testing performed in a routine clinical practice helps to identify the majority of women with high-grade disease. However, testing may be more beneficial in older women (age ≥ 30 years) with ASCUS. Strategy using out-of-vial reflex testing is more cost-effective and sensitive than referring all women for colposcopies.",
keywords = "Age and race, Atypical squamous cells of undetermined significance (ASCUS), Human papillomavirus (HPV), Hybrid capture (HC II), Liquid-based, Routine ThinPrep testing (TPPT), Triage",
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T1 - Reflex human papillomavirus DNA testing on residual liquid-based (TPPT™) cervical samples

T2 - Focus on age-stratified clinical performance

AU - Sarode, Venetia Rumnong

AU - Werner, Claudia

AU - Gander, Rita

AU - Foster, Barbara

AU - Fulmer, Amy

AU - Saboorian, M. Hossein

AU - Ashfaq, Raheela

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N2 - BACKGROUND. Liquid-based ThinPrep technology has made reflex human papillomavirus (HPV) DNA testing possible. In the current study, the clinical performance of reflex HPV testing as an adjunct to routine ThinPrep testing (TPPT) and the impact of age on various test parameters in a predominantly high-risk, minority population were evaluated retrospectively. METHODS. Reflex HPV testing was performed in 2114 women with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) cytology, using probes for low-risk (LR) and high-risk (HR) HPV types. Six hundred thirty women underwent subsequent biopsies with which HPV testing results were correlated. RESULTS. Approximately 86% of the patients were Hispanic and African-American and 12% were white. Of the younger women (ages 14-29 years), 81% were positive for HR types versus 50% in the older women (ages 30-77 years) (P < 0.0001). In women with ASCUS, 47% were found to be positive for HR types versus 78% of women with LSIL. The percentage of histologic high-grade lesions was 24% in younger patients versus 17% in older patients. Overall, 91% of high-grade lesions were positive for HPV DNA (HR-positive = 89% and LR-positive = 2%), and 9% were negative for both types. The sensitivities and specificities in "younger" versus "older" women were 92% (95% confidence interval [95% CI], 89-95%) and 22%% (95% CI, 17-26%), respectively, versus 84% (95% CI, 77-90%) and 59% (95% CI, 53-65%), respectively. CONCLUSIONS. The results of the current study demonstrate that reflex HPV testing performed in a routine clinical practice helps to identify the majority of women with high-grade disease. However, testing may be more beneficial in older women (age ≥ 30 years) with ASCUS. Strategy using out-of-vial reflex testing is more cost-effective and sensitive than referring all women for colposcopies.

AB - BACKGROUND. Liquid-based ThinPrep technology has made reflex human papillomavirus (HPV) DNA testing possible. In the current study, the clinical performance of reflex HPV testing as an adjunct to routine ThinPrep testing (TPPT) and the impact of age on various test parameters in a predominantly high-risk, minority population were evaluated retrospectively. METHODS. Reflex HPV testing was performed in 2114 women with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesion (LSIL) cytology, using probes for low-risk (LR) and high-risk (HR) HPV types. Six hundred thirty women underwent subsequent biopsies with which HPV testing results were correlated. RESULTS. Approximately 86% of the patients were Hispanic and African-American and 12% were white. Of the younger women (ages 14-29 years), 81% were positive for HR types versus 50% in the older women (ages 30-77 years) (P < 0.0001). In women with ASCUS, 47% were found to be positive for HR types versus 78% of women with LSIL. The percentage of histologic high-grade lesions was 24% in younger patients versus 17% in older patients. Overall, 91% of high-grade lesions were positive for HPV DNA (HR-positive = 89% and LR-positive = 2%), and 9% were negative for both types. The sensitivities and specificities in "younger" versus "older" women were 92% (95% confidence interval [95% CI], 89-95%) and 22%% (95% CI, 17-26%), respectively, versus 84% (95% CI, 77-90%) and 59% (95% CI, 53-65%), respectively. CONCLUSIONS. The results of the current study demonstrate that reflex HPV testing performed in a routine clinical practice helps to identify the majority of women with high-grade disease. However, testing may be more beneficial in older women (age ≥ 30 years) with ASCUS. Strategy using out-of-vial reflex testing is more cost-effective and sensitive than referring all women for colposcopies.

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KW - Triage

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