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

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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. Cancer (Cancer Cytopathol) 2003;99:149–55. © 2003 American Cancer Society.