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

The 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).The 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.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]. Cervical cancer is the second most common cancer in women, with a yearly incidence of 15.8 per 100,000 (crude rate), causing more than 270,000 deaths in 2008 [2]. Other diseases with clinical relevance are also related to HPVs infection, such as genital warts or intraepithelial lesions and cancer of the vulva, penis, vagina and anus [3-5].More than 150 different PVs infecting humans have been described [6]. Initially, and 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 also present in other genital lesions (penile or vulvar carcinomas). On the other hand, 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].Because of the clinical and economical rel