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P5.073 Comparison of Cobas® 4800 HPV Assay to Digene Hybrid Capture 2, Roche Linear Array, and Amplicor in the Detection of High-Risk Human Papillomavirus Genotypes in Women with Previous Abnormal Pap Smears
  1. S N Tabrizi1,2,3,
  2. S Phillips1,
  3. S M Garland1,2,3
  1. 1Regional HPV Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women’s Hospital, Parkville, Australia
  2. 2Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Australia
  3. 3Murdoch Childrens Research Institute, Parkville, Australia

Abstract

Introduction Cobas® 4800 HPV assay has been evaluated as a screening and triage application recently. The aim of this study was to evaluate the performance of the Cobas® 4800 HPV assay for the detection and identification of high-risk (HR) HPV genotypes after treatment of high grade lesion by comparison with the Hybrid Capture 2® (HC2), Amplicor (Amp), and Linear Array (LA) HPV tests.

Methods Four hundred and six PreservCyt® specimens from women undergoing management for a high-grade Pap abnormality were evaluated and results compared with the HC2, Amp, and LA HPV test results, in addition to histological diagnosis of a contemporaneously collected biopsy.

Results The sensitivity in detection of underlying high-grade histological diagnosis by Cobas® 4800 HPV was 90.6%, for HC2 86.1%, whilst for Amp and LA 92.9% and 91.8% respectively. Restricting detection of Cobas® 4800 HPV to only types 16 and 18 resulted in sensitivity of 60.0%. Detection of HR genotypes by Cobas® 4800 HPV showed a concordance of 86.9%, 96.1%, and 96.3% when compared to HC2, Amp and LA respectively. Detection of HPV 16 and 18 by Cobas® 4800 HPV showed a concordance of 97.3% and 99% respectively when compared to LA.

Conclusion The performance of Cobas® 4800 HPV was equivalent to the Amp and LA HPV tests for HR HPV detection. Cobas® 4800 HPV identified more underlying histologically-confirmed high-grade lesions than the HC2 HPV test, with the added advantage of identifying HPV 16 and 18 genotypes present.

  • detection
  • Human papillomavirus

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