In situ hybridization for high-risk HPV RNA identified the presence of high-risk HPV mRNA in cervical biopsies from women with prior high-risk HPV negative ASC-H or HSIL paps.

Summary: The Aptima HPV assay is a nucleic acid amplification test for qualitative detection of E6/E7 mRNA from 14 high-risk HPV (hrHPV) types in cervical specimens collected in ThinPrep vials. In women 30 years of age and older hrHPV testing is used in conjunction with Pap testing. Aptima hrHPV test has a sensitivity of 61.5%, specificity of 95.2%, and negative predictive value of 99.9% for detection of CIN3 in this age group with negative Pap result. This test has been FDA approved for PreserveCyt solution. Studies have shown no changes in the test performance on samples collected in SurePath medium, except difference in signal strength and slightly lower positivity rates. Up to 90% of HSIL Paps are hrHPV positive and CIN2 is identified in up to 70% of subsequent biopsies. Ancillary testing such as p16 and in situ hybridization for hrHPV RNA (hrHPV-RISH), which detects E6/E7 mRNA from 18 hrHPV subtypes are used in surgical pathology to confirm HSIL diagnosis. This study focused on Pap and biopsy findings in women initially diagnosed with hrHPV negative, ASC-H or HSIL Paps.