Development and evaluation of a new biochip Nucleic Acid Test (NAT) multi-target for cervical cancer screening

Cervical cancer is the fourth most common cancer in women and the cytological screening represents the most diffuse method of prevention. Human papillomavirus (HPV) is an established essential etiological factor for this cancer. Persistence of HPV infection, particularly by those belonging to the high-risk types (HR-HPV), is associated with an increased risk for cervical cancer development. Low-risk HPV (LR-HPV) types are more often associated with benign warts. Most invasive carcinomas are caused by two HR-HPV types: HPV16 and 18. Recently, HPV tests are used as an adjunct test to decrease the falsenegative rate of cytological screening with Papanicolaou test (PAP Test), especially HR-HPV DNA detection tests are useful for primary screening of cervical cancer and for triage of patients with equivocal cytological findings. However, the roles and contributions of other uncommon and rare genotypes remain uncertain, especially in specific geographic areas or populations. Recently, microarray biochip technology has been introduced into the clinical laboratory for HPV detection. One such test is the ProDect® CHIP HPV TYPING KIT (bcs Biotech Srl, Italy), which has the ability to identify 19 HPV types (all HR-HPV and most common LR-HPV types) and detect the generic presence of E6/E7 HR-HPV sequences. The aim of this pilot study was design a new biochip (CHIP PLUS) for the cervical cancer screening able to detect a large number of HPV anogenital types (HR- and LR-HPV) using two regions of the viral genome (L1 and E6/E7 sequences) as targets. This report also presents the results of a preliminary validation study in preparation for an extended clinical validation of the medical diagnostic ProDect® CHIP HPV TYPING PLUS employing the above CHIP PLUS designed both for the simultaneous detection of 31 HPV types (both common and uncommon HPV types) and for the characterization of three E6/E7 consensus sequences belonging to the principal groups of HR-HPV. The preliminary results of the ProDect® CHIP HPV TYPING PLUS KIT validation had higher concordance and/or greater compatibility with those of the reference tests, underlining the importance of searching for uncommon HPV types, enabling good prevention of cervical cancer using HPV DNA as test screening.