Evaluation of the hologic gen-probe aptima HPV assay with the panther system

Abstract

The Royal Prince Alfred Hospital (RPAH) receives gynecological samples from previously clinically screened high risk patients. In February 2012 the Microbiology Department at RPAH evaluated the APTIMA HPV (AHPV) assay on the fully automated PANTHER system. This assay is a target amplification nucleic acid probe test that utilises target capture for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk HPV types. The E6 and E7 genes from high-risk genotypes are known oncogenes. 201 ThinPrep specimens were tested in parallel using the Digene Hybrid Capture 2 (HC2) HPV DNA assay and AHPV assay. The results from each assay were directly compared to each other. Cytological and/or histological findings were used to aid resolution of discordant results. The overall agreement between the assays was 92.4%. The sensitivity specificity, positive predictive value and negative predictive value were as follows: for the AHPV assay, 97.1%, 96.9%, 94.3% and 98.4%; and for the HC2 assay, 91.2%, 97.7%, 95.4% and 95.5%. In this small sample size study of tertiary referral samples, the AHPV assay demonstrated good clinical performance. The PANTHER, which is a random access instrument capable of performing up to four different assays at one time, has very significant workflow advantages in comparison with the HC2 assay.