Performance of the digene LQ, RH and PS HPVs genotyping systems on clinical samples and comparison with HC2 and PCR-based Linear Array

Jose M Godínez,Silvia De Sanjosé,Marylène Lejeune,Sara Tous,María Alejo,Judith Moreno-Crespi,Nuria Baixeras,F Xavier Bosch,Ignacio G Bravo

doi:10.1186/1750-9378-6-23

Abstract

BackgroundCertain Human Papillomaviruses (HPVs) are the infectious agents involved in cervical cancer development. Detection of HPVs DNA is part of the cervical cancer screening protocols and HPVs genotyping has been proposed for its inclusion in these preventive programs. The aim of this study was to evaluate three novel genotyping tests, namely Qiagen LQ, RH and PS, in clinical samples with and without abnormalities. For this, 305 cervical samples were processed and the results of the evaluated techniques were compared with those obtained in the HPVs diagnostic process in our lab, by using HC2 and Linear Array (LA) technologies.ResultsThe concordances and kappa statistics (k) for each technique compared with HC2 were 98.69% (k = 0.94) for LQ, 98.03% (k = 0.91) for RH and 91.80% (k = 0.82) for PS. There was a very good agreement in HPVs type-specific concordance for the most prevalent types HPV16 (kappa range = 0.83-0.90), HPV18 (k.r.= 0.74-0.80) and HPV45 (k.r.= 0.82-0.90).ConclusionsThe three tests showed an overall good concordance for HPVs detection when compared with HR-HC2 system. LQ and RH rendered lower detection rate for multiple infections than LA genotyping. However, our understanding of the clinical significance of multiple HPVs infections is still incomplete and therefore the relevance of the lower ability to detect multiple infections needs to be evaluated.

Highlights

Certain Human Papillomaviruses (HPVs) are the infectious agents involved in cervical cancer development
Human Papillomaviruses (HPVs) are among the most common viruses identified in sexually active women all around the world, and persistence of the HPVs infection is a necessary step for the development of cervical cancer [1]
For the comparison of the results, only HPVs genotypes shared by the different assays were considered, i.e. when probes for the detection of the genotype in the samples are included in Hybrid Capture 2 test (HC2)/Linear Array (LA) but not in other of the analyzed tests, the sample is consider as HPVs negative for the test

Summary

Introduction

Certain Human Papillomaviruses (HPVs) are the infectious agents involved in cervical cancer development. Human Papillomaviruses (HPVs) are among the most common viruses identified in sexually active women all around the world, and persistence of the HPVs infection is a necessary step for the development of cervical cancer [1]. On the basis of epidemiological studies of prevalence in cervical lesions, HPVs with genital tropism were classified either as Low Risk (LR-HPVs) or High Risk (HR-HPVs) [7]. Oncogenic types such as HPV16, 18, 31 and 45 are responsible for the vast majority of all cervical cancers worldwide [8], and are present in other genital lesions (penile or vulvar carcinomas). LR-HPVs, such as HPV6 or HPV11, are usually described as non-oncogenic and are associated to benign lesions such as genital warts, condylomas or low grade genital carcinomas [9]

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