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The use of molecular assays in the management of viral hepatitis |
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| Authors: | A Mangia F Antonucci M Brunetto M Capobianchi S Fagiuoli M Guido P Farci P Lampertico A Marzano G Niro G Pisani D Prati M Puoti G Raimondo T Santantonio A Smedile F Lauria for the Italian Association for the Study of the Liver |
| Institution: | aLiver Unit, IRCCS, Ospedale “Casa Sollievo della Sofferenza” San Giovanni Rotondo, Italy bDivision of Infectious Diseases, INMI, IRCCS “L.Spallanzani”, Roma, Italy cDivision of Gastroenterology and Hepatology, AOU Pisana, Italy dDivision of Virology, INMI, IRCCS “L.Spallanzani”, Roma, Italy eDivision of Gastroenterology, Ospedali Riuniti, Bergamo, Italy fInstitute of Pathology, University of Padova, Italy gInstitute of Internal Medicine, University of Cagliari, Italy hDivision of Gastroenterology, IRCCS Maggiore Hospital, Milano, Italy iDivision of Gastroenterology and Hepatology, AO San Giovanni Battista, Torino, Italy jDivision of Gastroenterology, IRCCS, San Giovanni Rotondo, Italy kNational Health Institute, Rome, Italy lBlood Center Ospedale, Lecco, Italy mInstitute of Infectious and Tropical Disease, Univerisity of Brescia, Italy nDepartment of Internal Medicine, University of Messina, Italy oInstitute of Infectious Disease, University of Bari, Italy pPulmonary Disease Division, INMI, IRCCS “L.Spallanzani”, Roma, Italy |
| Abstract: | Molecular assays are instrumental in the clinical management of viral hepatitis. During the past years, a wide variety of molecular assays have been developed and implemented. This considerably improved the understanding of the natural history and pathogenesis of Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Hepatitis delta virus (HDV) hepatitis, but also caused uncertainties in the selection of the most appropriate assays for clinical requirements. Indeed, a rational choice and application of these assays requires adequate knowledge of the performance of the single test. Moreover, the choice of the most accurate assay for patients’ needs and physicians’ objectives, needs to be oriented to specific contexts, such as diagnosis, management or treatment. In the past, a hurdle in the routine use of assays for hepatitis viruses nucleic acid quantification was represented by the availability of only “home brew” methods which lacked standardization. Major improvement in addressing the use of molecular assays for viral hepatitis has been derived from recent standardization procedures that allowed a comparison between different tests after results were given as International Units. In addition, it should be reminded that, before getting into the market, molecular assays should be approved by European regulation authorities and validated using internationally recognized standards. A subsequent clinical validation should address the diagnostic accuracy of the assay. These proceedings have the aim of identifying which molecular tests, among those currently available, meet clinical requirements for each specific application. |
| Keywords: | Genotypes HDV RNA Qualitative HCV RNA Quantitative HBV DNA Quantitative HCV RNA Viral hepatitis |
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