[Evaluation of a prototype real-time PCR assay for the separate detection of human papilloma virus genotypes 16 and 18 and other high risk human papillomavirus in cervical cancer screening]

Abstract

Background: It has recently been confirmed that detection of DNA of human papilloma virus (HPV) is more useful than cytology in the screening for cervical cancer, especially if genotypes 16 and 18 are identified. Cobas 4800 is an automated system that detects 14 high risk HPV genotypes: genotypes 16 and 18 separately and 12 other high-risk genotypes pooled.

Objectives: The aim of this study is to compare the performance of the cobas 4800 HPV test against the hybrid capture 2 (HC2) and particularly in women in whom>CIN2 lesions are detected.

Patients and methods: Aliquots from 412 cervical specimens have been studied with three different assays, real time PCR (cobas 4800), Linear Array HPV test, and HC2. Cytological and histological results were also available.

Results: There was good agreement between the cobas 4800 and HC2 results in 376 of the 412 women (kappa 0.85). Where there was not good agreement, low-risk HPV genotypes were detected by linear array in the majority of samples positive by HC2 and negative by the cobas 4800. Sensitivity and specificity for detecting>CIN2 lesions were 92.5 and 44%, respectively, by cobas 4800, and 88 and 51% by hybrid capture.

Conclusions: In this evaluation the cobas 4800 HPV test was shown to have a similar performance to the HC2 test. However HC2 was less specific due to cross reactivity with low risk genotypes, mainly genotype 53. Cobas 4800 is very reliable in the detection of high-risk genotypes, with the advantage of simultaneously providing information regarding genotype16 and 18 infections.