09. Specific terms of reference for the NRC for congenital infections including: Toxoplasma, rubella, cytomegalovirus and parvovirus B19 0B AIMS: 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 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 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. Version 2014 1 09. Specific terms of reference for the NRC for congenital diseases including: Toxoplasma, rubella, cytomegalovirus and parvovirus B19 1B General missions: 6B 1) 2) 3) 4) 5) 6) 7) To confirm the diagnosis and to give scientific and technical support for result interpretation. To monitor circulating strains by performing microbial typing. To maintain an up to date knowledge on the different aspects of congenital infections and on each pathogen. To actively participate in national surveillance. To actively collaborate with existing relevant networks. To request epidemiological information on confirmed cases of congenitally infected children. To transfer microbiological data (through e-health reporting) and scientifically report the analysed data for public health concerns 1. Toxoplasma 2B The NRC must be able to (level of competences): 7B 1) 2) 3) 4) To confirm the serological diagnosis by detection of specific IgG and IgM, and avidity methods. To detect T. gondii by molecular techniques. To perform genotyping To provide reference material (Strains, DNA, spiked samples…) Tasks that will be asked in a particular context: 8B 1) 2) 3) 4) 5) 6) To confirm the diagnosis on request. To contribute to the development of new diagnostic techniques. To request epidemiological data related to pregnancy, clinical diagnosis, outcome … To collaborate with international working groups. To collaborate with animal health reference labs. To improve the surveillance representativeness by enlarging the action radius (geographical coverage). 2. Rubella 3B The NRC must be able to (level of competences): 9B 1) 2) 3) To confirm the serological diagnosis by detection of specific antibodies (IgM and IgG). To detect viral RNA by RT-PCR. To have access to whole genome sequencing. Version 2014 2 Tasks that will be asked in a particular context: 10B 1) 2) 3) 4) 5) To confirm congenital infections on request. To request data related to the vaccinal status (date of doses) and to the pregnancy on confirmed cases. To recommend vaccination to seronegative pregnant women in postnatal period. To collaborate with the committee for rubella eradication. To improve the surveillance representativeness by enlarging the action radius (geographical coverage). 3. Cytomegalovirus (CMV) 4B The NRC must be able to (level of competences): 11B 1) 2) 3) 4) To confirm the serological diagnosis by detection of specific IgG and IgM, and avidity methods. To perform CMV culture and CMV PCR. To perform genotyping To have access to whole genome sequencing. Tasks that will be asked in a particular context: 12B 1) 2) 3) 4) 5) 6) To confirm the diagnosis of congenital infection in the child in pre- and postnatal period. To request epidemiological data related to the pregnancy status, the CMV infection status of the mother if the newborn is infected. To participate to the seroprevalence monitoring in population groups. To provide technical advice for prevention recommendations. To establish contacts with paediatricians and obstetricians. To improve the surveillance representativeness by enlarging the action radius (geographical coverage). 4. Parvovirus B19 5B The NRC must be able to (level of competences): 13B 1) 2) 3) To confirm the serological diagnosis by detection of specific IgG and IgM. To detect the viral DNA by molecular techniques. To have access to whole genome sequencing. Tasks that will be asked in a particular context: 14B 1) To confirm congenital infections. Version 2014 3 2) To improve the surveillance representativeness by enlarging the action radius (geographical coverage). Version 2014 4