Clinical sensitivity of HPV assays for the detection of high grade cervical disease in cervical samples treated with glacial acetic acid

Abstract

Background: Lysis of bloody liquid based cytology (LBC) specimens with glacial acetic acid (GAA) is performed to aid cytological interpretation. However, the influence of GAA treatment on HPV detection is not fully understood and in studies designed to assess this, few cases of high-grade disease have been included.

Objectives: To assess the sensitivity of HPV molecular tests for the detection of high grade cervical disease in GAA treated samples

Study design: A total of 207 specimens associated with high grade dyskaryosis and treated with GAA were collated prospectively. Overall 140 specimens had underlying CIN2+, including 88 CIN3. All specimens were tested with the Abbott RealTime High Risk HPV test (rtHPV) and the Qiagen Hybrid Capture 2High Risk HPV DNA test (HC2). Specimens associated with a CIN2+ that were negative by either assay were genotyped.

Results: The sensitivity of rtHPV for CIN2+ and CIN3+ was 92.8% (87.2, 96.5) and 94.3% (87.2, 98.1) respectively. Sensitivity of the HC2 for CIN2+ and CIN3+ was 97.2% (92.8, 99.2) and 96.6% (90.3, 99.2) respectively. The sensitivity of both assays in GAA treated specimens was thus consistent with the level required for clinical application. HPV negative, CIN2+ specimens were generally attributable to HPV types outside the explicit analytical range of the assays.

Conclusions: The data indicate that GAA treatment has little impact on the detection of CIN2+ by HPV testing in LBC specimens.

Keywords: Cervical; Glacial acetic acid; HPV; Molecular detection.