National Reference Laboratory for Viral Hepatitis
6. March 2012
The NRL is accredited to ČSN EN ISO/IEC 17025 as a test laboratory and to ČSN EN ISO 15189 as a public health laboratory by the Czech Accreditation Institute.
- NRL performs serological and molecular diagnostic of viral hepatitis (VH) A-E. NRL performs confirmatory testing for the subjects who were reactive when tested for HBV and HCV screening markers by Blood Transfusion Service (mandatory) or field diagnostic laboratories upon request). The aim of the confirmatory testing is to verify the specificity of results using a set of EIA tests, specific confirmatory assays and DNA/RNA tests, when needed.
- NRL performs specialized testing by molecular biological methods to detect clinically important mutations, genotyping by sequence analysis, and diagnosis of non-endemic hepatitis cases.
- NRL provides reference activities such as expert opinions, reports, position statements, and guidelines for the needs of the Ministry of Health of the Czech Republic and other institutions. Moreover, NRL performs analyses requiring a professional interpretation background or the arbitrary status of the reference laboratory.
- NRL prepares test samples for the National External Quality Assessment Scheme (EHK) and analyzes the EHK results achieved by more than 190 participating blood transfusion and diagnostic laboratories in the Czech Republic. Proficiency testing series for the serological markers HAV, HBV, and HCV and HBV DNA and HCV RNA are produced.
- NRL participates in research projects focused on the molecular epidemiology of hepatitis viruses, phylogenetic characterization of the agents, and sequence analysis feasible in practice, including the maintenance of the database of HBV and HCV nucleotide sequences.
- NRL provides pregraduate and postgraduate training and education
- The NRL participates in the international external quality assessment and proficiency testing schemes of the Institute for Standardization and Documentation in Medical Laboratories INSTAND e.V., (Germany), and of the European Directorate for the Quality of Medicines & HealthCare (EDQM PTS).