OIE Reference Laboratory Reports Activities in 2012 Name of disease (or topic) for which you are a designated OIE Reference Laboratory: Bovine Tuberculosis Address of laboratory AHVLA, New Haw, Addlestone, Surrey, UK KT15 3NB Tel.: 01932 341111 Fax: 01932 357260 e-mail address: Glyn.Hewinson@ahvla.gsi.gov.uk website: www.defra.gsi.gov.uk/ahvla Name (including Title) of Head of Laboratory (Responsible Official): Chris Hadkiss Name (including Title and Position) of OIE Reference Expert: Prof Glyn Hewinson, Chief Scientist Date of submission to the OIE 25/01/13 Instructions This form should be used by an OIE Reference Laboratory to report activities that took place from January through December of the past year (2012), unless otherwise stated, and must be submitted by the end of January every year. Only those activities that concern the disease (or topic) for which the laboratory is recognised by the OIE should be mentioned. The questionnaire structure follows the Terms of Reference (ToRs) for OIE Reference Laboratories, available at: http://www.oie.int/en/our-scientific-expertise/reference-laboratories/introduction/ Each ToR (blue italicised text) has been placed as a heading covering the group of questions related to it. Please note the red italicised text is given as guidance and should be deleted from your report and substitute with your data. Examples are based on past Annual Reports or have been invented. The questionnaire represents a means of gathering information on activities carried out by OIE Reference Laboratories and making it available to OIE Member Countries and to the OIE Reference Laboratory network. This annual report will remain available for consultation on the OIE web site: (http://www.oie.int/en/our-scientific-expertise/reference-laboratories/annual-reports/): Annual reports of OIE Reference Centres, 2012 1 OIE RL for « Bovine Tuberculosis » – « Prof Glyn Hewinson » – « United Kingdom » ToR: To use, promote and disseminate diagnostic methods validated according to OIE Standards Test recommended by the OIE Total number of test performed last year Indirect diagnostic tests Nationally Internationally Lateral flow serology test - camelid 361 5 Lateral flow serology test - badger 511 0 Gamma interferon micro (2Ag) assay (cattle) 45,313 0 Gamma interferon extended micro (3Ag) assay (cattle) 238 0 Direct diagnostic tests Nationally Internationally Culture (bovine) 13477 0 Culture (non bovine) 808 0 HAIN & Multiplex PCRs 15 0 DNA testing of cattle to confirm identity tallies with ear tag 224 0 Spoligotyping 3984 0 VNTR 3984 0 ToR: To develop reference material in accordance with OIE requirements, and implement and promote the application of OIE Standards. To store and distribute to national laboratories biological reference products and any other reagents used in the diagnosis and control of the designated pathogens or disease. 2. Did your laboratory produce or store imported standard reference reagents officially recognised by the OIE or other international bodies? Yes 3. Did your laboratory supply standard reference reagents to OIE Member Countries? Yes 4. No No Did your laboratory produce diagnostic reagents other than the OIE-approved standard reference reagents? Yes No DIVA antigens (synthetic peptide and recombinant proteins for skin testing and Gamma-Interferon assay: NZ (3 mg) Spain (75 mg) Denmark (6 mg) 5. Did your laboratory produce vaccines? Yes 2 No Annual reports of OIE Reference Centres, 2012 OIE RL for « Bovine Tuberculosis » – « Prof Glyn Hewinson » – « United Kingdom » 6. Did your laboratory supply vaccines to OIE Member Countries? Yes No Vaccine name Amount supplied nationally (ml, mg) (including for own use) Amount supplied to other countries (ml, mg) Name of recipient OIE Member Countries Badger BCG 3060 doses N/A Great Britain ToR: To develop, standardise and validate, according to OIE Standards, new procedures for diagnosis and control of the designated pathogens or diseases 7. Did your laboratory develop new diagnostic methods validated according to OIE Standards for the designated pathogen or disease? Yes 8. No Did your laboratory develop new vaccines according to OIE Standards for the designated pathogen or disease? Yes No Name of the new test or diagnostic method or vaccine developed TB DIVA blood test Description and References (Publication, website, etc.) A dossier detailing the DIVA blood test was circulated to the OIE experts on TB, and their comments have been received and documented ToR: To provide diagnostic testing facilities, and, where appropriate, scientific and technical advice on disease control measures to OIE Member Countries 9. Did your laboratory carry out diagnostic testing for other OIE Member Countries? Yes No Name of OIE Member Country seeking assistance Date (dd/mm) No. samples received for provision of diagnostic support (i.e. from surveillance campaign) No. samples received for provision of confirmatory diagnoses Sweden 06/06 0 5 (alpaca sera for TB StatPak testing) 10. Did your laboratory provide expert advice in technical consultancies on the request of an OIE Member Country? Yes No Name of the OIE Member Country receiving a technical consultancy Purpose Ireland Delivery of oral vaccine to badgers Preparation of vaccine doses and local training EURL (Madrid) Diagnosis of TB in camelids Training in camelid IFNgamma assay Annual reports of OIE Reference Laboratories, 2012 How the advice was provided 3 OIE RL for « Bovine Tuberculosis » – « Prof Glyn Hewinson » – « United Kingdom » ToR: To carry out and/or coordinate scientific and technical studies in collaboration with other laboratories, centres or organisations 11. Did your laboratory participate in international scientific studies in collaboration with OIE Member Countries other than the own? Yes No OIE Member Countries involved other than your country Title of the study Duration Purpose of the study Partners (Institutions) European 2 – a clonal complex of Mycobacterium bovis dominant in the Iberian Peninsula. 1 year To determine the population structure of M. bovis in the Iberian Peninsula European Union Reference Laboratory (EURL) Spain The effect of repeat BCG vaccination on the specificity of a blood based DIVA test 6 months To determine if repeat BCG vaccination effects the specificity of a blood based DIVA test European Union Reference Laboratory (EURL) Spain To assess the suitability of the IFNgamma test as a stand-alone test for gaining, maintaining, suspending, withdrawing or regaining official BTB-free status AHVLA (UK), CVI Lelystad, UCD, Ag. Academy, Lublin, Fed. Res. Inst. For An. Health, Madrid TB Ref. Lab, Fed. Vet. Office, National TB Ref. Lab. , IZSLER, Vet. Agro. Research Centre. EFSA: Scientific Opinion on the use of the IFNgamma test for the diagnosis of BTB ~ 4 months Netherlands, Ireland, Poland, Germany, Spain, Switzerland, France, Italy, Belgium Evaluation of oral vaccine efficacy in badgers Ongoing To evaluate vaccine efficacy in a low dose challenge model UCD Ireland Field evaluation of BCG vaccination in cattle ongoing See study title Armauer Hansen Research Institute and Addis Ababa University Ethiopia Evaluation of DIVA skin test reagents in cattle Ongoing To evaluate the performance of DIVA skin test reagents in cattle AgResearch New Zealand 4 Annual reports of OIE Reference Centres, 2012 OIE RL for « Bovine Tuberculosis » – « Prof Glyn Hewinson » – « United Kingdom » ToR: To collect, process, analyse, publish and disseminate epizootiological data relevant to the designated pathogens or diseases 12. Did your Laboratory collect epizootiological data relevant to international disease control? Yes 13. No Did your laboratory disseminate epizootiological data that had been processed and analysed? Yes No Descriptive bTB epidemiological data for GB that are collated and presented every year in the form of annual bTB surveillance reports for GB and Wales. Links are given below to the 2010 reports. (The 2011 reports are in preparation.) http://www.defra.gov.uk/animal-diseases/files/Surveillance-annual-report-2010.pdf http://www.defra.gov.uk/animal-diseases/files/Surveillance-mid-year-report-Jul-10-Jun-11.pdf http://new.wales.gov.uk/topics/environmentcountryside/ahw/disease/bovinetuberculosis/researchand evidence/bovinetbannualsurvreport10/;jsessionid=B8CA2FBDA7E4B3475F9865CD8DBC6310?lang=en 14. What method of dissemination of information is most often used by your laboratory? (Indicate in the appropriate box the number by category) a) Articles published in peer-reviewed journals: ................. 34 b) International conferences: .............................................. 4 c) National conferences: ...................................................... 5 d) Other: ............................................................................... 1 1. Ameni G, Cockle P, Lyashchenko K, Vordermeier M. T-cell and antibody responses to mycobacterial antigens in tuberculin skin-test-positive Bos indicus and Bos taurus cattle in Ethiopia. Veterinary Medicine International 2012; 2012: 457872. 2. Aranday-Cortes E, Hogarth PJ, Kaveh DA, et al. Transcriptional profiling of disease-induced host responses in bovine tuberculosis and the identification of potential diagnostic biomarkers. PLoS One 2012; 7(2): e30626. 3. Bhuju S, Aranday-Cortes E, Villarreal-Ramos B, Xing Z, Singh M, Vordermeier HM. Global gene transcriptome analysis in vaccinated cattle revealed a dominant role of IL-22 for protection against bovine tuberculosis. PLoS Pathog 2012; 8(12): 3077. 4. Carter SP, Chambers MA, Rushton SP, et al. BCG vaccination reduces risk of tuberculosis infection in vaccinated badgers and unvaccinated badger cubs. PLoS One 2012; 7(12): e49833. 5. Casal C, Bezos J, Diez-Guerrier A, et al. Evaluation of two cocktails containing ESAT-6, CFP-10 and Rv-3615c in the intradermal test and the interferon-gamma assay for diagnosis of bovine tuberculosis. Prev Vet Med 2012; 105(1-2): 149-54. 6. Conlan AJK, McKinley TJ, Karolemeas K, et al. Estimating the hidden burden of bovine tuberculosis in Great Britain. PLoS Comput Biol 2012; 8(10): e1002730. 7. Corner LAL, O'Meara D, Costello E, Lesellier S, Gormley E. The distribution of Mycobacterium bovis infection in naturally infected badgers. Vet J 2012; 194(2): 166-72. 8. Firdessa R, Tschopp R, Wubete A, et al. High prevalence of bovine tuberculosis in dairy cattle in central Ethiopia: implications for the dairy industry and public health. PLoS One 2012; 7(12): e52851. 9. Flores-Villalva S, Suarez-Guemes F, Espitia C, Whelan AO, Vordermeier M, Gutierrez-Pabello JA. Specificity Annual reports of OIE Reference Laboratories, 2012 5 OIE RL for « Bovine Tuberculosis » – « Prof Glyn Hewinson » – « United Kingdom » of the tuberculin skin test is modified by use of a protein cocktail containing ESAT-6 and CFP-10 in cattle naturally infected with Mycobacterium bovis. Clin Vaccine Immunol 2012; 19(5): 797-803. 10. Gavier-Widen D, Chambers M, Gortazar C, Delahay R, Cromie R, Linden A. Mycobacteria infections. In: Gavier-Widen D, Duff JP, Meredith A, eds. Infectious diseases of wild mammals and birds in Europe. Chichester: Wiley-Blackwell; 2012: 265-92. 11. Gideon HP, Wilkinson KA, Rustad TR, et al. Bioinformatic and empirical analysis of novel hypoxia-inducible targets of the human antituberculosis T cell response. J Immunol 2012; 189(12): 5867-76. 12. Goodchild AV, Watkins GH, Sayers AR, Jones JR, Clifton-Hadley RS. Geographical association between the genotype of bovine tuberculosis in found dead badgers and in cattle herds. Vet Rec 2012; 170(10): 257. 13. Gumi B, Schelling E, Berg S, et al. Zoonotic transmission of tuberculosis between pastoralists and their livestock in South-East Ethiopia. EcoHealth 2012; 9(2): 139-49. 14. Hogan L, Bhuju S, Jones DC, et al. Characterisation of bovine leukocyte Ig-like receptors. PLoS One 2012; 7(4): e34291. 15. Jones GJ, Whelan A, Clifford D, Coad M, Vordermeier HM. Improved skin test for differential diagnosis of bovine tuberculosis by the addition of Rv3020c-derived peptides. Clin Vaccine Immunol 2012; 19(4): 6202. 16. Karolemeas K, de la Rua-Domenech R, Cooper R, et al. Estimation of the relative sensitivity of the comparative tuberculin skin test in tuberculous cattle herds subjected to depopulation. PLoS One 2012; 7(8): e43217. 17. Kaveh DA, Whelan AO, Hogarth PJ. The duration of antigen-stimulation significantly alters the diversity of multifunctional CD4 T cells measured by intracellular cytokine staining. PLoS One 2012; 7(6): e38926. 18. Khatri BL, Coad M, Clifford DJ, Hewinson RG, Whelan AO, Vordermeier HM. A natural-transmission model of bovine tuberculosis provides novel disease insights. Vet Rec 2012; 171(18): 448. 19. Palgrave CJ, Benato L, Eatwell K, Laurenson IF, Smith NH. Mycobacterium microti infection in two meerkats (Suricata suricatta). J Comp Pathol 2012; 146(2-3): 278-82. 20. Pérez de Val B, Nofrarias M, Lopez-Soria S, et al. Effects of vaccination against paratuberculosis on tuberculosis in goats: diagnostic interferences and cross-protection. BMC Vet Res 2012; 8: 191. 21. Pérez de Val B, Villarreal-Ramos B, Nofrarias M, et al. Goats primed with Mycobacterium bovis BCG and boosted with a recombinant adenovirus expressing Ag85A show enhanced protection against tuberculosis. Clin Vaccine Immunol 2012; 19(9): 1339-47. 22. Pirson C, Jones GJ, Steinbach S, Besra GS, Vordermeier HM. Differential effects of Mycobacterium bovis derived polar and apolar lipid fractions on bovine innate immune cells. Vet Res 2012; 43: 54. 23. Rhodes S, Holder T, Clifford D, et al. Evaluation of gamma interferon and antibody tuberculosis tests in alpacas. Clin Vaccine Immunol 2012; 19(10): 1677-83. 24. Thom ML, McAulay M, Vordermeier HM, et al. Duration of immunity against Mycobacterium bovis following neonatal vaccination with bacillus Calmette-Guerin Danish: significant protection against infection at 12, but not 24, months. Clin Vaccine Immunol 2012; 19(8): 1254-60. 25. Tomlinson A, Chambers M, Delahay R. Mycobacterium bovis infection in badger cubs: re-assessing the evidence for maternally derived immunological protection from advanced disease. Vet Immunol Immunopathol 2012; 148(3-4): 326-30. 26. Tree JA, Smith S, Baker N, et al. Method for assessing IFN-gamma responses in guinea pigs during TB vaccine trials. Lett Appl Microbiol 2012; 55(4): 295-300. 27. Turner C, Knobloch H, Richards J, et al. Development of a device for sampling cattle breath. Biosyst Eng 2012; 112(2): 75-81. 28. Twomey DF, Collins R, Cranwell MP, et al. Controlling tuberculosis in a llama (Lama glama) herd using clinical signs, tuberculin skin testing and serology. Vet J 2012; 192(2): 246-8. 29. Vordermeier HM, Hewinson RG, Wilkinson RJ, et al. Conserved immune recognition hierarchy of 6 Annual reports of OIE Reference Centres, 2012 OIE RL for « Bovine Tuberculosis » – « Prof Glyn Hewinson » – « United Kingdom » mycobacterial PE/PPE proteins during infection in natural hosts. PLoS One 2012; 7(8): e40890. 30. Vordermeier M, Ameni G, Berg S, et al. The influence of cattle breed on susceptibility to bovine tuberculosis in Ethiopia. Comp Immunol Microbiol Infect Dis 2012; 35(3): 227-32. 31. Vordermeier M, Ameni G, Glass EJ. Cytokine responses of Holstein and Sahiwal zebu derived monocytes after mycobacterial infection. Trop Anim Health Prod 2012; 44(3): 651-5. 32. Vordermeier M, Whelan AO. ELISPOT assays to enumerate bovine IFN-gamma-secreting cells for the development of novel vaccines against bovine tuberculosis. Methods in Molecular Biology 2012; 792: 21927. 33. Waters WR, Palmer MV, Buddle BM, Vordermeier HM. Bovine tuberculosis vaccine research: historical perspectives and recent advances. Vaccine 2012; 30(16): 2611-22. 34. Waters WR, Thacker TC, Nonnecke BJ, et al. Evaluation of gamma interferon (IFN-gamma)-induced protein 10 responses for detection of cattle infected with Mycobacterium bovis: comparisons to IFN-gamma responses. Clin Vaccine Immunol 2012; 19(3): 346-51. 35. Whelan A, Court P, Xing Z, et al. Immunogenicity comparison of the intradermal or endobronchial boosting of BCG vaccinates with Ad5-85A. Vaccine 2012; 30(44): 6294-300. ToR: To provide scientific and technical training for personnel from OIE Member Countries To recommend the prescribed and alternative tests or vaccines as OIE Standards 15. Did your laboratory provide scientific and technical training to laboratory personnel from other OIE Member Countries? Yes No a) Technical visits: ................................................................ 7 b) Seminars: ......................................................................... 1 c) Hands-on training courses: .............................................. 1 d) Internships (>1 month): ................................................... Type of technical training provided (a, b, c or d) Country of origin of the expert(s) provided with training No. participants from the corresponding country a Afghanistan 1 a Korea 3 a Sweden 1 a,b,c Ethiopia 1, 24, 24 a Spain 1 ToR: To maintain a system of quality assurance, biosafety and biosecurity relevant for the pathogen and the disease concerned 16. Does your laboratory have a Quality Management System certified according to an International Standard? Yes Annual reports of OIE Reference Laboratories, 2012 No 7 OIE RL for « Bovine Tuberculosis » – « Prof Glyn Hewinson » – « United Kingdom » Quality management system adopted ISO 17025 – accreditation standard ISO 9001 – certification standard Good Distribution Practice (GDP) 94/C63/03 Good Laboratory Practice (GLP) 17. Is your laboratory accredited by an international accreditation body? Yes No Test for which your laboratory is accredited Accreditation body Culture (bovine & non bovine) UKAS Gamma Interferon Elisa UKAS Culture (bovine & non bovine) GLP Spoligotyping UKAS 18. Does your laboratory maintain a “biorisk management system” for the pathogen and the disease concerned? (See Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2012, Chapter 1.1.3 or Manual of Diagnostic Tests for Aquatic Animals 2012, Chapter 1.1.1) Yes No ToR: To organise and participate in scientific meetings on behalf of the OIE 19. Did your laboratory organise scientific meetings on behalf of the OIE? Yes 20. No Did your laboratory participate in scientific meetings on behalf of the OIE? Yes No ToR: To establish and maintain a network with other OIE Reference Laboratories designated for the same pathogen or disease and organise regular inter-laboratory proficiency testing to ensure comparability of results 21. Did your laboratory exchange information with other OIE Reference Laboratories designated for the same pathogen or disease? Yes 22. No Was your laboratory involved in maintaining a network with OIE Reference Laboratories designated for the same pathogen or disease by organising or participating in proficiency tests? Yes No Purpose of the proficiency tests: (validation of a diagnostic protocol: specify the test; quality control of vaccines: specify the vaccine type, etc.) Role of your Reference Laboratory (organiser/ participant) No. participants A dossier detailing the DIVA blood test that could be used in the face of BCG vaccination in cattle was circulated to the OIE experts on TB, and their comments have been received and documented organiser 2 8 Participating OIE Ref. Labs/ organising OIE Ref. Lab. Gerencia de Laboratorios (GELAB) del Servicio Nacional de Sanidad y Calidad, ARGENTINA Annual reports of OIE Reference Centres, 2012 OIE RL for « Bovine Tuberculosis » – « Prof Glyn Hewinson » – « United Kingdom » Agence Nationale de Sécurité Sanitaire de l'Alimentation, de l'Environnement et du Travail (Anses) FRANCE 23. Did your laboratory collaborate with other OIE Reference Laboratories for the same disease on scientific research projects for the diagnosis or control of the pathogen of interest? Yes No ToR: To organise inter-laboratory proficiency testing with laboratories other than OIE Reference Laboratories for the same pathogens and diseases to ensure equivalence of results. 24. Did your laboratory organise or participate in inter-laboratory proficiency tests with laboratories other than OIE Reference Laboratories for the same disease? Yes No No. participating laboratories Participating OIE Member Countries N/A N/A – only a participant MIRU-VNTR comparative test – July 2012 N/A N/A – only a participant 2011 Ring trial DNA extraction and culture – submitted March 2012 N/A N/A – only a participant Evaluation of the DIVA skin test 2 New Zealand, USA Inter-laboratory reproducibility of the DIVA blood test 2 Spain (EURL) The effect of repeat BCG vaccination on the specificity of the DIVA blood test 2 Spain (EURL) Inter-laboratory reproducibility of the DIVA blood test 2 Spain (EURL) Purpose for inter-laboratory test comparisons1 Comparative test INTERFERON GAMMA – 2012 Dec ToR: To place expert consultants at the disposal of the OIE 25. Did your laboratory place expert consultants at the disposal of the OIE? Yes 1 No Kind of consultancy Location Subject (facultative ) Member of Biological Standards Commission Paris and AHVLA Responding to requests for consultancy on test validation Attendance at BSC meetings, comments on papers etc AHVLA Test validatio See Interlaboratory test comparisons in: Laboratory Proficiency Testing at: www.oie.int/en/our-scientific-expertise/reference-laboratories/proficiency-testing see point 1.3 Annual reports of OIE Reference Laboratories, 2012 9