17. Specific terms of reference for the NRC for hepatitis B, C, D, E viruses
AIMS:
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Each National Reference Centre (NRC) must meet both the general and the specific terms
of reference.
In the specific terms of reference, the NRC tasks dedicated to each selected pathogen or
group of pathogens are described.
It aims to guarantee the knowledge, the know-how and the epidemiological surveillance
expertise of each NRC.
The tasks list is not exhaustive and can be modified in function of the requirements and
the evolution of knowledge and techniques.
In the event a NRC is unable to perform a specific task, this can be subcontracted to
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preserve the knowledge in the NRC. If this is the case, quality of the subcontracted task
has to be proven and assured.
Each list of specific terms of reference is divided into three parts: 1) a reminder of the
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specific missions, 2) a description of the tasks that the NRC must be able to do including
the competencies and 3) a list of the tasks that will be asked in a particular context.
The type of analysis indicated for each specific pathogen in each particular situation
(diagnosis or confirmation, typing, sensitivity to antimicrobial substances, virulence…) is
defined.
The collaboration with existing surveillance systems (e.g. ECDC) and with other reference
centres (food safety reference centres, veterinary reference centres) are also a priority.
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17. Specific terms of reference for the NRC for hepatitis B, C, D, E viruses
Specific missions:
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3)
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5)
6)
To perform the diagnosis for HDV and HEV.
To actively participate in surveillance of antiviral resistance of circulating strains.
To actively participate in the assessment of vaccine impact for HBV.
To actively participate in national surveillance of hepatitis virus infections.
To actively collaborate with existing networks.
To transfer microbiological data (through e-health reporting) and scientifically report
the analysed data for public health concerns.
The NRC must be able to (level of competences):
For hepatitis B:
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To detect the presence of specific antibodies and antigens.
To develop, validate and perform a fast diagnostic test for non-invasive samples
(salivary tests…)
To detect and quantitate the presence of viral genome.
To genotype the isolates.
To perform HBV genome sequencing to detect recombinant HBV strains and to detect
mutant variants.
To perform resistance genotyping (to detect mutations that convey resistance to HBV
antivirals).
To have access to whole genome sequencing.
For hepatitis C:
1)
2)
3)
4)
5)
6)
To detect and quantitate HCV RNA in blood.
To detect anti-HCV antibodies.
To develop, validate and perform a fast diagnostic test for non-invasive samples
(salivary tests…)
To genotype the isolates.
To further characterise HCV strains as the need evolves (i.e. detection of drugresistance mutations in protease, NS5A and NS5B-polymerase genes).
To have access to whole genome sequencing.
For hepatitis D:
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2)
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4)
To detect anti-delta antibodies.
To detect and quantitate HDV RNA in blood.
To genotype the isolates
To have access to whole genome sequencing.
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For hepatitis E:
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2)
3)
4)
To detect anti-HEV antibodies.
To detect HEV RNA in blood.
To actively collaborate with other centres to characterize HEV.
To have access to whole genome sequencing.
Tasks that will be asked in a particular context:
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2)
3)
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7)
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To perform the HDV and HEV diagnosis in clinically and laboratory suspected cases.
To characterize HBV (mutant variants, drug resistance).
To characterize HCV (mutant variants, drug resistance).
To have access to the detection of host genetic factors (IL28B,…) with an impact on
disease progression or clinical decision making.
To set up a surveillance network for HBV and HCV based on a representative subset of
routine laboratory results and data centralization.
To request epidemiological data on the vaccination status, date of doses, profession…
To actively collaborate with blood safety control laboratories, i.e. Red Cross, Biological
Standardisation of the IPH.
To participate to seroprevalence studies when requested.
To perform nosocomial HBV or HCV outbreak analysis using genome sequencing and
phylogenic analysis.
To improve the surveillance representativeness by enlarging the action radius
(geographical coverage and/or by collaborative work with other networks).
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