TY - JOUR
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
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2003/6/25
Y1 - 2003/6/25
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.
KW - Age and race
KW - Atypical squamous cells of undetermined significance (ASCUS)
KW - Human papillomavirus (HPV)
KW - Hybrid capture (HC II)
KW - Liquid-based
KW - Routine ThinPrep testing (TPPT)
KW - Triage
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U2 - 10.1002/cncr.11190
DO - 10.1002/cncr.11190
M3 - Article
C2 - 12811855
AN - SCOPUS:0038458967
SN - 0008-543X
VL - 99
SP - 149
EP - 155
JO - Cancer
JF - Cancer
IS - 3
ER -