National Reference Laboratory for Leptospirosis

1. NRL experts

• NRL coordinator

  Dr. Guţu Emanuela, PhD candidate
  tel. 0374.322.032
  e–mail: emanuela.gutu@idah.ro

• NRL deputy coordinator

  Dr. Rădulescu Ruxandra Alina, PhD in medical sciences, veterinary medicine speciality

• Team working

  Dr. Răgălie Adriana, PhD candidate
  Bg. Petriceanu Gela
  Bg. Vanghele Luminiţa, PhD candidate
  Dr. Priocop Lavinia, PhD candidate
  Dr. Dragoş Daniela, post-university studies in veterinary laboratory diagnosis
  Dr. Adameşteanu Mihai
  Dr. Bădulescu Raluca
  Dr. Visarion Magdalena
  Dr. Pavel Nerone

2. Correspondent Community Reference Laboratory

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3. Specific atributions

• The specialists working in this NRL have the responsibility for drawing up the handbook „Manual for Animal Leptospirosis Diagnosis”.
• They also perform the changes and/or supplements for „Manual for Animal Leptospirosis 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 leptospirosis.
• The experts coordinate pre-taking and drawing up the standards and diagnostic methods of animal leptospirosis in Romania.
• They carry out researches activities, assimilate and draw up the new analytical methods for laboratory diagnosis and surveillance of animal leptospirosis.
• They participate together with the others national reference laboratories for animal leptospirosis from Member States, to the international inter-comparison and proficiency tests organized by international reference laboratories for animal leptospirosis and other international accredited institutions in the field.
• They participate to the quality assurance activities and method standardization for diagnosis, surveillance and screening of animal leptospirosis, organized by international reference laboratories for animal leptospirosis.
• The NRL specialists collaborate with international reference laboratories for animal leptospirosis and benefit from training organized by these and supplying diagnostic standards, methods, reagents or diagnosis standards for animal leptospirosis.
• The NRL experts collaborate with national reference laboratories for animal leptospirosis 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 leptospirosis.
• In accordance with provisions of diagnosis manuals, they carry out the laboratory tests/assays for diagnosis and surveillance of animal leptospirosis.
• The NRL experts supply the diagnosis expertise for animal leptospirosis 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 leptospirosis 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 leptospirosis and designate their use by state sanitary veterinary laboratories from Romania.
• In preparation for yielding certain diagnosis reagents for animal leptospirosis, supplying them for all authorised sanitary veterinary and food safety laboratories.
• They coordinate the drawing up of diagnosis standards and methods for animal leptospirosis 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 leptospirosis, 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 leptospirosis.
• The NRL experts proceed specific activities in order to identify and characterize the etiological agents of contagious bovine pleuropneumonia, their origin, type and subtype.
• NRL has the responsibility to characterize the animal leptospirosis etiological agent strains, their genetic typing and designing the epidemiological genetic charts.
• They preserve the animal leptospirosis 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 leptospirosis 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, international reference laboratories for animal leptospirosis, World Animal Health Organization, national reference laboratories for animal leptospirosis 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 animal leptospirosis with the aim of establishing the national strategies and policies animal leptospirosis.
• 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 leptospirosis, 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 leptospirosis and to calibration of national reference secondary sera against international primary standard sera.
• They participate to the elaboration of law drafts for animal leptospirosis.
• They also participate to design the technical programs, the national and international projects regarding animal leptospirosis 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
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• Attendance to trainings
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• Participation to the international inter–comparison and proficiency tests
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5. Activity in relation with correspondent national reference laboratories from Member States

• Attendance to workshops
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• Attendance to trainings
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• Participation to the international inter–comparison and proficiency tests
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6. Activity in relation with correspondent international reference laboratory

• Attendance to workshops
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• Attendance to trainings
  • 1995 - Laboratory methods for animal leptospirosis diagnosis – ROYAL TROPICAL INSTITUTE, Amsterdam, the Netherlands
  • 2004 - Laboratory methods for animal leptospirosis diagnosis – ROYAL TROPICAL INSTITUTE, Amsterdam, the Netherlands
  • 2006 - Laboratory methods for animal leptospirosis diagnosis - AFBI, LEPTOSPIRA UNIT VETERINARY SCIENCES DIVISION, BELFAST, IRLANDA DE NORD
• Participation to the international inter–comparison and proficiency tests
  • 2004 – International Proficiency Testing Scheme for leptospirosis MAT, ROYAL TROPICAL INSTITUTE, Amsterdam, the Netherlands
  • 2005 – International Proficiency Testing Scheme for leptospirosis MAT, ROYAL TROPICAL INSTITUTE, Amsterdam, the Netherlands
  • 2006 – International Proficiency Testing Scheme for leptospirosis MAT, ROYAL TROPICAL INSTITUTE, Amsterdam, the Netherlands
  • 2007 – International Proficiency Testing Scheme for leptospirosis MAT, ROYAL TROPICAL INSTITUTE, Amsterdam, the Netherlands
  • 2008 – International Proficiency Testing Scheme for leptospirosis MAT, ROYAL TROPICAL INSTITUTE, Amsterdam, the Netherlands

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

• Attendance to workshops
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• Attendance to trainings
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• Participation to the international inter–comparison and proficiency tests
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8. Activity in relation with counties SVFSLs

• Workshop organization
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• Training organization
  • 2006- Serological tests for animal leptospirosis diagnosis by MAT
  • 2007- Serological tests for animal leptospirosis diagnosis by MAT
  • 2008- Serological tests for animal leptospirosis diagnosis by MAT
  • 2009- Serological tests for animal leptospirosis diagnosis by MAT
• Performing inter–comparison and proficiency tests
  • 2004 - Proficiency Testing Scheme by inter-laboratory comparison for leptospirosis MAT
  • 2008 - Proficiency Testing Scheme by inter-laboratory comparison for leptospirosis MAT

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

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