App 24 item 9 Evaluation Report for NRL FMD laboratories ... · 39-th General Session of EU FMD Commission, 27-27 April, 2011, Roma, Italy RT-PCR (real or conventional) 8. 1 of 11

EVALUATION REPORTEVALUATION REPORT

for NRL FMD laboratories of Balkan countries

39-th General Session of EU FMD Commission, 27-27 April, 2011, Roma, Italy

Balkan countries

Prof. Dr. Georgi Georgiev,DVSci

BULGARIA

The aim:

To summarize the progress of FMDNRLs of the Balkanic countries in theirdiagnostic capacity

(scope and range of analytical


(scope and range of analyticaldiagnostic methods, needs fordiagnostic tools, training, knowledgeand experience, accreditation level andparticipation 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


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


• 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











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


(reference) materials

• Organization/participation of proficiency tests (PT)

• Developing accreditation strategyregarding 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)


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


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 FMDLPBL 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


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


10. Most of the NRLs are used developed and validated Standard Operating Procedures (SOPs) for methods routinely performed at the


methods routinely performed at the lab., but few of them used standard (reference) materials distributed by WRL,UK


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


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 NRLsbelongs has accreditation of methodsunder ISO 17025, but for FMDV – not!

The reason is small number of


The reason is small number ofsamples received for testing

13. Only few FMD NRLs (BG, Rom, Ser)declared accreditation of methods forFMDV Ag and Ab detection covering theISO-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


• 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.


agreed upon.

Recommendations:

Because 12 of 13 countries in the regionare accepted non vaccination policy for

FMD control NS ELISA tests should be

used for serology survey investigations


used for serology survey investigations

Further characterisation of some positiveswill be confirmed through WRL ordedicated labs in the region should beagreed 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


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 andenhancing capacity of relevant expertsfrom the veterinary authorities of thecountries from the region should be a


countries from the region should be apriority of EU FMD commisiion

involving in this responsibility oneor more of its country memberstates

Recommendations:

• Reenforcement of the competentauthorities to implement continuoussurveillance system for confirming thenegative status of each Balkannic


negative status of each Balkanniccountry is esential!

• Enlarging the number of investigatedsamples will support the accreditationpolicy of the conrties for covering theISO 17025 standard methods.

National Veterinary ServiceNational Veterinary Service

BULGARIABULGARIA

Thank you for your

39-th General Session of EU FMD Commission, 27-27 April, 2011,

Roma, Italy

Thank you for your attention!

Documents

App 24 item 9 Evaluation Report for NRL FMD laboratories ... · 39-th General Session of EU FMD Commission, 27-27 April, 2011, Roma, Italy RT-PCR (real or conventional) 8. 1 of 11