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Journal of Clinical Microbiology, May 2008, p. 1641-1646, Vol. 46, No. 5
0095-1137/08/$08.00+0     doi:10.1128/JCM.01824-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

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

C. C. Ginocchio,* D. Barth, and F. Zhang

North Shore-Long Island Jewish Health System Laboratories, Department of Molecular Diagnostics, Lake Success, New York

Received 13 September 2007/ Returned for modification 14 February 2008/ Accepted 12 March 2008

This study compared the clinical performance of the Digene Hybrid Capture 2 (HC2) assay to that of a prototype Third Wave Invader human papillomavirus (HPV) (IHPV) analyte-specific reagent-based assay for the detection of oncogenic or "high-risk" (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 those 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 fewer 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).

* Corresponding author. Mailing address: North Shore-Long Island Jewish Health System Laboratories, 10 Nevada Drive, Lake Success, NY 11042. Phone: (516) 719-1079. Fax: (516) 719-1254. E-mail: cginocch{at}nshs.edu

{triangledown} Published ahead of print on 26 March 2008.

Journal of Clinical Microbiology, May 2008, p. 1641-1646, Vol. 46, No. 5
0095-1137/08/$08.00+0     doi:10.1128/JCM.01824-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.





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