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.