Development and validation of in vitro diagnostic devices for HPV and HIV-1

Sexually transmitted viral infections represent a global health problem. More than one million of these infections are estimated to be acquired everyday globally. HPV and HIV-1 infections are two of the most studied because of their large diffusion and their link with important diseases. The HPV prevalence and the mortality linked to cervical cancer have decreased thanks to vaccination and to screening programs. In this study, the performance of an assay detecting 14 high risk HPV genotypes, based on the Real time PCR methodic, has been tested, in order to verify if the device is suitable for the use in cervical cancer screening according to Meijer’s guideline. The validation tests were performed in order to define the parameters of clinical specificity, sensitivity, intra- and inter-reproducibilities of this assay. These tests proved it performed well and it is suitable for the use in primary cervical cancer screening. Moreover, the evaluation of analytical and diagnostic performance suggests that this HPV detection device fits the requirements of the Directive 98/79/CE regarding the in vitro diagnostic medical devices, therefore it is suitable for commercialization. Regarding HIV-1 infections, the quantification of viral DNA is a fundamental parameter for the therapeutic management of positive patients, however its application in the diagnostic routine is delayed by the lack of standardized systems available in commercial formulations. Particularly, the evaluation of HIV DNA levels before and during antiretroviral therapy can be useful to evaluate a therapy change or suspension and to assess its effectiveness. On this basis, the development and validation of a Real time PCR device for the identification and the quantification of the HIV-1 DNA able to satisfy the performance requirements for its use on the diagnostic field, were carried out. The assay’s validation, which allowed evaluating its analytical and diagnostic performance, indicates that it is suitable for the use in the research field. Indeed, it has already been commercialized as a Research Use Only (RUO) device.