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.
- Human papillomavirus