Clinical Performance of a Human Papillomavirus Messenger RNA Test (Aptima HPV Assay) on Residual Material From Archived 3-Year-Old PreservCyt Samples With Low-Grade Squamous Intraepithelial Lesion

Abstract

Context.—Human papillomavirus (HPV) testing is widely used in the triage of women with a borderline smear result but the efficiency of testing women with low-grade squamous intraepithelial lesion (LSIL) is less clear, mainly because of lack of specificity. New HPV tests are emerging, which detect E6/E7messenger RNA (mRNA), and preliminary data suggest that they might have a higher specificity. However, mRNA is less stable than DNA, thus posing a challenge to the preservation abilities of the cell-collecting medium. Objective.—To evaluate the clinical performance of an HPV mRNA assay on 3-year-old archived liquid-based samples, all with a diagnosis of LSIL. Design.—The residual material from old archived PreservCyt samples from 442 women were tested with the Aptima HPV Assay, which detects E6/E7 mRNA from 14 high-risk HPV types. The samples had been stored at room temperature without any further handling. Results.—Follow-up was available for 405 women, 67 of whom had histologic confirmed cervical intraepithelial neoplasia (CIN) 2+ and 31 with CIN 3+. The sensitivity and specificity for the mRNA assay was 92.5% and 38.2%, respectively, for detecting CIN 2+, and 93.9% and 35.5%, respectively, for detecting CIN 3+. When evaluating separately the performance of the test for women younger than 30 years and for women 30 years or older, the sensitivity was found to be similar in the 2 groups, but the specificity was significantly lower for the younger women. Conclusion.—Messenger RNA is well preserved in old archived PreservCyt samples. Triaging women with LSIL, using the Aptima HPV Assay, seems to be effective with a good sensitivity and a good specificity, especially for women 30 years or older.