Collaborative study Brazil-Portugal - alidation of HPV lyophilized samples for the control of molecular tests

摘要

There are about 120 types of Human Papilloma Virus (HPV). The major importance about it is the oncogenic potential of some types. They are referred asa high and low risk for oncogenic potential. Given the importance of the disease it causes, and the use of different laboratorial techniques, mainly techniques of molecularbiology, it is mandatory to have an External Quality Assurance (EQA) program base on harmonized standards that rely on consistent controls. The participation in EQA’sprograms is mandatory in laboratorieswith an ISO 15189/17025 accreditation implemented.The control of Molecular Biology techniques is absolutely necessary for the quality assurance of the results, the tracking and monitorization of the performance of the reagents.However, one of its limitations is the stability, homogeneity of the material, (ISO/IEC 17043:2010 requisite) as well as the availability of control samples adequate for theparameter to be analyzed. The PNCQ, in order to fill this gap, lyophilised the HPV samples control. In order to do the validation and to test the reproducibility of theselyophilized samples, PNCQ sent to IBIOTECNO , INSA-PNAEQ -DDI and the IPOLFG-SPCLV to be analysed by different methods and reagents in two different countries anddifferent laboratories.