Valutazione di controlli di qualità per sistemi di amplificazione molecolare qualitativi e quantitativi nella ricerca di HBV-DNA, HCV-RNA, CMV-DNA, e HIV-DNA

Abstract

NAT (Nucleic Acid Amplification Technology) assays are now widely used in diagnostic microbiology. The implementation of NAT assays requires the use and the availability of control reagents, with various aims, such as to verify the efficiency of the procedures and the comparability of the results obtained among different laboratories. At this purpose, the Committee for the Study of Biotechnologies (CoSBio) of AMCLI performed a study to evaluate a group of synthetic quality controls for the detection of HBV-DNA, HCV-RNA, HIV-DNA e CMV-DNA, commercially distributed by AlfaWassermann. Here we report the results of the first part of the study performed to assess the main characteristics of these reagents and their applicability to different diagnostic systems. In the second part, the same controls will be evaluated in a national multicentre study.

Keywords

• Quality control, amplification assay, molecular diagnosis, standardization