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Comparative Study
. 2007 Sep-Oct;51(5):749-54.
doi: 10.1159/000325838.

A human papillomavirus testing system in women with abnormal Pap results: a comparison study with follow-up biopsies

Ming Guo  1 , Shobha J Patel, Marilyn Chovanec, Yee Jee Jan, Emily Tarco, Therese B Bevers, Keith Anderson, Nour Sneige
Affiliations
Comparative Study

A human papillomavirus testing system in women with abnormal Pap results: a comparison study with follow-up biopsies

Ming Guo et al. Acta Cytol. 2007 Sep-Oct.

Abstract

Objective: To evaluate the efficacy of INFORM HPV using the SurePath collection method in women whose Pap tests indicated abnormal results.

Study design: Ninety-two women from the gynecology clinics at The University of Texas M.D. Anderson Cancer Center who had Pap tests and underwent follow-up biopsies were selected for the study. This included 51 women with atypical squamous cells of undetermined significance (ASCUS), 23 women with low-grade squamous intraepithelial lesion (LSIL), 15 women with high-grade squamous intraepithelial lesion (HSIL) and 3 women with negative Pap results. The INFORM HPV, an in situ hybridization assay, testing for oncogenic types of HPV was performed, and the results were compared with follow-up biopsies.

Results: The positive rate of the INFORM HPV increased with higher grades of cytology diagnoses. The sensitivity of the INFORM HPV testing for predicting high-grade cervical intraepithelial neoplasia (CIN 2/3) also increased with higher grades of cytology diagnoses. A negative predictive value (NPV) of 94.9% and a specificity of 80.4% for predicting CIN 2/3 were observed in the ASCUS group.

Conclusion: Using SurePath Pap specimens, the INFORM HPV lacks sufficient sensitivity and NPV for predicting CIN 2/3 in women with ASCUS. Therefore, use of the test as a triage tool is limited.

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