Comparison of the Third Wave Invader HPV Assay and the Digene HPV Hybrid Capture 2 Assay for the Detection of High-Risk Human Papillomavirus DNA

North Shore – Long Island Jewish Health System Laboratories, Department of Molecular Diagnostics, Lake Success, NY

^* To whom correspondence should be addressed. Email: cginocch{at}nshs.edu.

	Abstract

This study compared the clinical performance of the Digene Hybrid Capture 2 (HC2) assay to a prototype Third Wave Invader HPV (IHPV) analyte specific reagent based assay for the detection of HR HPV DNA using liquid based cytology specimens. In total, 821 ThinPrep vials were tested using both assays. In accordance with the type specific probes contained within each test, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the IHPV assay were 95.9%, 97.6%, 97.5% and 96.1%, respectively and for the HC2 assay were 98.1%, 86.2%, 87.1% and 97.9%. Overall, the sensitivity and NPV were comparable between the assays, but the IHPV assay demonstrated a better specificity and PPV since the IHPV assay had less false positive HR HPV results. The incorporation of an internal control to evaluate the cellularity of the test material is an important feature of the IHPV assay and should reduce the risk of false negative results due to insufficient sample collection rather than the lack of HR HPV DNA. An additional benefit of the IHPV assay was the smaller sample volume required (1 mL) versus 4 ml for the HC2 assay.