for NRL FMD laboratories of Balkan countries Prof. Dr. Georgi Georgiev,DVSci BULGARIA

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EVALUATION REPORT for NRL FMD laboratories of Balkan countries Prof. Dr. Georgi Georgiev,DVSci BULGARIA

The aim: To summarize the progress of FMD NRLs of the Balkanic countries in their diagnostic capacity (scope and range of analytical diagnostic methods, needs for diagnostic tools, training, knowledge and experience, accreditation level and participation in ring tests)

The goals is : 1. To evaluate the diagnostic capacity and identify the needs for training and other forms of support 2. To find the gaps and weaknesses of different countries/nrls and submit the proposal to the EC for improving the situation with FMD surveillance in these countries through the EU FMD Commission mechanism

The surveyed countries 2010 were: Albania UN/FAO, EU FMD Serbia UN/FAO, EU FMD, negotiated with EU Montenegro UN/FAO Macedonia UN/FAO Bosnia & Herzegovina UN/FAO Croatia - UN/FAO, negotiated with EU Bulgaria UN/FAO, EU FMD, member of EU Romania UN/FAO, EU FMD member of EU Kosovo special status UN Moldova UN/FAO Slovenia - UN/FAO, EU FMD, member of EU

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

Session of Exc. Commity of EU FMD Comission, Vienna, 2010

First set of questions: Methods for FMD antigen and antibody detection used routinely in your NRL Development of Standard Operating Procedures (SOPs) and using standard (reference) materials Organization/participation of proficiency tests (PT) Developing accreditation strategy regarding the ISO 17025 standard, level of accreditation and EQ&A

Second set of questions: Organization of workshops/training courses/ simulating exercises Ad hoc (real time) trainings delivered by the WRL/EU-RL or other institutions (i.e. trainings provided to your NRL/ONL in addition to / or organized in connection with the annual workshops) Other activities carried out by the FMD WRL/EU-RL (not mentioned in this questionnaire) able to assist FMD NRL over the last 5 years Sharing the information and communication of NRLs with FMD WRL/EU-RL or other institutions

Conclusions: 1. 10/11 of 11 FMD diagnostic laboratories are determined as FMD NRLs of countries in the region 2. 9 of 11 FMD NRLs declare that WRL in Pirbright UK is their Reference laboratory 3. Only 4 of 11 can perform routinely FMD Ag ELISA 4. Only 4 of 11 can perform routinely FMD LPBL Ag ELISA

Conclusions (cont.): 5. Only 4 of 11 can perform routinely FMD SPCE Ab ELISA 6. 10 of 11 can perform routinely FMD NSP ELISA tests 7. Only 5 of 11 can perform routinely RT-PCR (real or conventional) 8. 1 of 11 can perform routinely FMD VI (but unfortunately up to 2010) 9. No one can perform routinely VNT

Conclusions (cont.): 10. Most of the NRLs are used developed and validated Standard Operating Procedures (SOPs) for methods routinely performed at the lab., but few of them used standard (reference) materials distributed by WRL,UK

Conclusions (cont.): 11.There are remarkable improvement for attempt to participate in a different levels of PT organized by WRL/EU FMD RL, UK 11.1. Five countries (Alb, Kos, Mol, B&H and Mon) are not participated in PT organized by WRL/EU FMD RL, Pirbright, UK 11.2. Other 6 countries (Cro, Ser, Mac, Rom, Slov, BG) in last 5 years try to cover different panel 1-4 levels of PT with inactivated or live virus materials

Accreditation strategy (ISO 17025 standard) and EQ&A: 12. Some of institutions that FMD NRLs belongs has accreditation of methods under ISO 17025, but for FMDV not! The reason is small number of samples received for testing 13. Only few FMD NRLs (BG, Rom, Ser) declared accreditation of methods for FMDV Ag and Ab detection covering the ISO-17025 standard

Recommendations: All labs in the region should be able to investigate clinical suspicions of FMD with a quick, reliable and sensitive test methods FMDV yes or no may be sufficient on a country level (Real-time) RT-PCR diagnostics and/or LFD tests should be implemented Harmonisation of test protocols is very important!

Recommendations: Type-specific diagnosis and further characterisation of strains through WRL and dedicated labs in the region should be agreed upon.

Recommendations: Because 12 of 13 countries in the region are accepted non vaccination policy for FMD control NS ELISA tests should be used for serology survey investigations Further characterisation of some positives will be confirmed through WRL or dedicated labs in the region should be agreed upon.

Recommendations: The tripartite mechansm under OIE, FAO, and EC for evaluation the control of FMD and other Exotic diseases (BT, S&G Pox, PPR, CSF) for Bulgaria, Greece and Turkey should be extended and finnaced under the GF TADS for Europe for other 9 countries in the Region (Alb, Mont, Ser, Cro, B&H, FYROM, Ro. Mol and Kos)

Recommendations: Training of laboratory staff and enhancing capacity of relevant experts from the veterinary authorities of the countries from the region should be a priority of EU FMD commisiion involving in this responsibility one or more of its country member states

Recommendations: Reenforcement of the competent authorities to implement continuous surveillance system for confirming the negative status of each Balkannic country is esential! Enlarging the number of investigated samples will support the accreditation policy of the conrties for covering the ISO 17025 standard methods.

National Veterinary Service BULGARIA Thank you for your attention! 39-th General Session of EU FMD Commission, 27-27 April, 2011, Roma, Italy