National Reference Laboratory for Brucellosis

1. NRL experts

• NRL coordinator

  Dr. Rădulescu Ruxandra Alina, PhD in medical sciences, veterinary medicine speciality
  tel. 0374322032
  e–mail: ruxandra.radulescu@idah.ro

• NRL deputy coordinator

  Dr. Guţu Emanuela, PhD candidate

• Team working

  Dr. Răgălie Adriana, PhD candidate
  Bg. Petriceanu Gela
  Dr. Ionescu Maria, PhD candidate Dr. Iordache Lucia, PhD in medical sciences, veterinary medicine speciality
  Bg. Vanghele Luminiţa, PhD candidate
  Dr. Pricop Lavinia, PhD candidate
  Dr. Bărbuceanu Florica, PhD in medical sciences, veterinary medicine specialty
  Dr. Dragoş Daniela, post-university studies in veterinary laboratory diagnosis
  Dr. Tudoran Cristina
  Dr. Visarion Magdalena
  Dr. Pavel Nerone

2. Correspondent Community Reference Laboratory

• Community Reference Laboratory for Brucellosis, French Food Safety Agency (AFSSA), F–94700, Maisons–Alfort, Cedex, France.

3. Specific atributions

• The specialists working in this NRL have the responsibility for drawing up the following handbooks: „Manual for Bovine Brucellosis Diagnosis”, „Manual for Swine Brucellosis Diagnosis”, „Manual for Small Ruminant Brucellosis Diagnosis” and „Manual for Carnivorous and Other Animal Brucellosis Diagnosis”.
• They also perform the changes and/or supplements for „Manual for Bovine Brucellosis Diagnosis”, „Manual for Swine Brucellosis Diagnosis”, „Manual for Small Ruminant Brucellosis Diagnosis” and „Manual for Carnivorous and Other Animals Brucellosis Diagnosis” in accordance with new provisions of Community law and new recommendations of the World Animal Health Organization, established in „Manual of Diagnostic Tests and Vaccines for Terrestrial Animals” and „Terrestrial Animal Health Code”.
• NRL experts approve the results of validity studies proving the reliability of methods/assays used in Romania for diagnosis and surveillance of animal brucelloses.
• The experts coordinate pre–taking and drawing up the standards and diagnostic methods of animal brucelloses in Romania.
• They carry out researches activities, assimilate and draw up the new analytical methods for laboratory diagnosis and surveillance of animal brucelloses.
• They participate together with the others national reference laboratories for brucellosis from Member States, to the international inter–comparison and proficiency tests organized by Community Reference Laboratory for Brucellosis.
• They participate to the quality assurance activities and method standardization for diagnosis, surveillance and screening of animal brucelloses, organized by Community Reference Laboratory for Brucellosis.
• The NRL specialists collaborate with Community Reference Laboratory for Brucellosis and benefit from training organized by this and supplying diagnostic standards, methods, reagents or diagnosis standards for brucellosis.
• The NRL experts collaborate with national reference laboratories for brucellosis from the others Member States, international reference laboratories of World Animal Health Organization (OIE) and other international accredited organizations in the field, in order to improve the surveillance and diagnostic capacity of animal brucelloses.
• In accordance with provisions of diagnosis manuals, they carry out the laboratory tests/assays for diagnosis and surveillance of animal brucelloses.
• The NRL experts supply the diagnosis expertise for animal brucelloses in case of positive, suspect and inconclusive results obtained by the sanitary veterinary and food safety county laboratories, and of Bucharest, respectively.
• The NRL experts supply the diagnosis expertise for animal brucelloses in case of dispute settlement.
• The NRL experts check and certify the diagnosis value of all diagnosis reagent batches and diagnosis sets or kits for animal brucelloses and designate their use by state sanitary veterinary laboratories from Romania.
• In preparation for yielding certain diagnosis reagents for animal brucelloses, supplying them for all authorised sanitary veterinary and food safety laboratories.
• They coordinate the drawing up of diagnosis standards and methods for animal brucelloses used by all authorized sanitary veterinary and food safety laboratories.
• The NRL experts perform the annual inter-laboratory comparative tests for checking the diagnostic capability for animal brucelloses, for all authorized sanitary veterinary and food safety county laboratories from county sanitary veterinary and food safety directorates.
• NRL also organize training and continuous training activities, in order to teach the specialists working in the authorized sanitary veterinary and food safety laboratories, on carrying out laboratory surveillance for animal brucelloses.
• The NRL experts proceed specific activities in order to identify and characterize the ethological agents of animal brucelloses, their origin, type, subtype and variant.
• NRL has the responsibility to characterize the animal brucelloses etiological agent strains, their genetic typing and designing the epidemiological genetic charts.
• They preserve the animal brucelloses etiological agent strains under maximum safety conditions.
• The experts from NRL participate to the authorization of sanitary veterinary and food safety laboratories; they write down the checking files and assessment report and verify the achievement of quality insurance system conditions.
• Periodically, they communicate to the European Commission the list of authorized and accredited institutions or sanitary veterinary and food safety laboratories, having specific competences for animal brucelloses and also to notify any changes of the list.
• The NRL experts communicate, with the agreement of National Sanitary Veterinary and Food Safety Authority, the information requested by European Commission, Community Reference Laboratory for Brucellosis, World Animal Health Organization, national reference laboratories for brucellosis from other Member States and other international accredited organizations and institutions in the field.
• The NRL experts provide, to National Sanitary Veterinary and Food Safety Authority and to sanitary veterinary and food safety county directorates, and of Bucharest, respectively, the official information on animal brucelloses with the aim of establishing the national strategies and policies on animal brucelloses.
• As a second or third part, they carry out advising activities, they grant technical advice and also they perform audit activities for institutions and organizations in animal husbandry or for those enterprises of which activities involve products or by–products derived from animals.
• Sometimes, the experts from NRL participate to inspection and control actions directed to animal brucelloses, organized by National Sanitary Veterinary and Food Safety Authority.
• In accordance with legislation in force, NRL promotes and implements the Good Laboratory Practice principles (GLP), to be used for applied research studies.
• They also participate to the drawing up, coordination, monitoring and carrying out some actions stipulated by “Programme for surveillance, prevention and control of animal diseases, those transmitted from animals to humans, animal and environmental protection”, yearly approved by National Sanitary Veterinary and Food Safety Authority President’s order.
• They participate to the establishing of maximum number of samples which are to be sampled for laboratory exams, regarding animal brucelloses, the maximum number of samples for laboratory exams done on pool samples and to calibration of national reference secondary sera against international primary standard sera.
• They participate to the elaboration of law drafts for animal brucelloses.
• •They also participate to design the technical programs, the national and international projects regarding animal brucelloses diagnosis and surveillance.
• The NRL experts participate or manage the research activities of national or international research programmes.

4. Activity in relation with correspondent Community Reference Laboratory

• Attendance to workshops
  • 2007 – „First meeting with Brucellosis NRL EU network”
  • 2008 – „False positive reactions in Brucellosis serology”
  • 2009 – „Sheep and goats Brucellosis”
• Attendance to trainings
  • –
• Participation to the international inter–comparison and proficiency tests
  • 2007 – 1–st Brucellosis serum EU Proficiency Ring – Trial 2007 – 2008, organized by Community Reference Laboratory for Brucellosis, AFSSA, F–94700, Maisons – Alfort, Cedex, France
  • 2008 – 1–st EU Brucellosis Milk iELISA Proficiency Ring – Trial organized by Community Reference Laboratory for Brucellosis, AFSSA, F–94700, Maisons – Alfort, Cedex, France
  • 2009 – iELISA Brucellosis Serology, organized by Community Reference Laboratory for Brucellosis, AFSSA, F-94700, Maisons - Alfort, Cedex, France

5. Activity in relation with correspondent national reference laboratories from Member States

• Attendance to workshops
  • –
• Attendance to trainings
  • 2001 – „Serology assays for Brucellosis – micro SAT” organized by National Reference Laboratory for Brucellosis, Berlin, Germany
• Participation to the international inter–comparison and proficiency tests
  • –

6. Activity in relation with correspondent international reference laboratory

• Attendance to workshops
  • –
• Attendance to trainings
  • 2002 – „Serological techniques applied in Brucellosis – CFT in microplate – OIE method and iELISA”, organized by International Reference Laboratory for Brucellosis, Weybridge, United Kingdom
  • 2006 – „Brucellosis serology”, organized by International Reference Laboratory for Brucellosis, Teramo, Italy
  • 2006 – Laboratory diagnosis methods used for Brucella spp. isolation and characterization, organized by International Reference Laboratory for Brucellosis, Teramo, Italy
• Participation to the international inter–comparison and proficiency tests
  • 2002 – Bovine Brucellosis Serology Ring Trial organized by International Reference Laboratory for Brucellosis, Veterinary Laboratory Agency, Weybridge, United Kingdom
  • 2005 – Bovine Brucellosis Serology Ring Trial, organized by International Reference Laboratory for Brucellosis, Veterinary Laboratory Agency, Weybridge, United Kingdom

7. Activity in relation with other international accredited institutions in the field

• Attendance to workshops
  • –
• Attendance to trainings
  • 1999 – “Animal Brucellosis – laboratory diagnosis” – SN Pasteur Institute SA, Romania
• Participation to the international inter–comparison and proficiency tests
  • 2007 – Brucellosis Serology – 12 participations on: RBT, SAT, CFT and iELISA organized by Veterinary Laboratory Agency, Sutton Bonington, United Kingdom
  • 2008 – Brucellosis Serology – 12 participations on: RBT, SAT, CFT and iELISA, organized by Veterinary Laboratory Agency, Sutton Bonington, United Kingdom
  • 2009 – 10 participations to the proficiency tests on “Brucellosis Serology - RBT, SAT, RFC and iELISA”, organized by Veterinary Laboratory Agency, Sutton Bonington, United Kingdom

8. Activity in relation with counties SVFSLs

• Workshop organization
  • –
• Training organization
  • 2006 – Serological techniques applied in surveillance of Brucellosis
  • 2006 – Homologated methods and methodologies for isolation and identification the Brucella genus etiological agents
  • 2007 – Introduction in validation of serological assays applied in diagnosis of bacterial diseases
  • 2007 – Complement fixation test – OIE microplate standard method, applied in serodiagnosis of Brucellosis
  • 2007 – Homologated methods and methodologies for isolation and identification the Brucella genus etiological agents
  • 2008 – Serological techniques applied in Brucellosis surveillance
  • 2008 – Complement fixation test – OIE microplate standard method, applied in serodiagnosis of Brucellosis
  • 2008 – Isolation and identification methods for Brucella genus etiological agents
  • 2009 – Isolation and identification methods for Brucella genus etiological agents
  • 2009 – 3 training activities on „Complement fixation test (OIE technique) used for diagnosis and surveillance of ovine epididymitis (Brucella ovis)”
• Performing inter–comparison and proficiency tests
  • 2005 – Serum Brucellosis serology by RBT, SAT and CFT
  • 2007 – Serum Brucellosis serology by RBT, SAT and CFT
  • 2008 – Serum Brucellosis serology by RBT, SAT and CFT
  • 2009 – Brucella spp. morpho-staining identification
  • 2009 – Testing for serological diagnosis capacity for ovine epididymitis (Brucella ovis)

9. Activity in relation with other institutions than SVFSLs or legal and private person

• Workshop organization
  • –
• Training organization
  • –
• Performing inter–comparison and proficiency tests
  • –