Report on Activities of Biological Standards Commission2015‒2016

Beverly Schmitt

President

Members Beverly Schmitt (USA) – President Franck Berthe (Italy) – Vice-President Hualan Chen (China) – Vice-President Tony Fooks (UK) – Member Mehdi El Harrak (Morocco) – Member Peter Daniels – (Australia) Member

Biological Standards Commission (BSC)

Biological Standards Commission

Formal meetings:1‒3 September 2015

2‒5 February 2016

Email communications

Activities in brief

OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

OIE Reference Centres (for terrestrial animals)

Ad hoc Groups International Standardisation /

HarmonisationStandardisation programmeOIE Register of diagnostic kits

Liaison with other Commissions

1. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual)

Activities

About the Terrestrial Manual update

Member Country comments are compiled by the OIE Secretariat

The Consultant Editor reviews them and brings issues to the BSC

The BSC approves changes or refers for further editing or input from subject matter experts

22 chapters are being proposed for adoption

The Commission reviewed extensively the structure and content of the Terrestrial Manual and agreed to disband the Enlarged Bureau Group

Chapters proposed for adoption

1.1.10 Vaccine banks

1.1.11 Standards for high throughput sequencing, bioinformatics and computational genomics

2.1.4. Brucellosis (Brucella abortus, B. melitensis and B. suis)

2.1.7 Japanese encephalitis

2.1.14 Rift Valley fever

2.2.15 Rinderpest

2.1.18 Tularemia

2.2.2 American foulbrood of honey bees

2.2.3 European foulbrood of honey bees

Chapters proposed for adoption

2.3.10 Fowlpox 2.3.12 Infectious bursal disease 2.4.6 Bovine spongiform encephalopathy 2.4.14 Lumpy skin disease 2.5.7 Equine influenza 2.6.2 Rabbit haemorrhagic disease 2.7.13 Scrapie 2.9.4 Cryptococcosis 2.9.9 Salmonellosis

Chapters proposed for adoption

3.6.8. Validation recommendation: Comparability of assays after minor changes in a validated test method

3.7. Recommendations for the manufacture of vaccines

3.7.1. Minimum requirements for the organisation and management of a vaccine manufacturing facility

3.7.2. Minimum requirements for the production and quality control of vaccines

3.7.3. Minimum requirements for aseptic production in vaccine manufacture

Corrections to chapters proposed for adoption

Brucellosis (Brucella Brucella abortus, B. melitensis and B. suis): After sent to Member Countries as the version to be proposed for adoption, Reference Laboratories noticed that the chapter states a vaccine strain can be purchased from the European Directorate for the Quality of Medicines. This is no longer the case; it can be purchased from one of the OIE Reference Laboratories for Brucellosis. The footnote has been amended

Corrections to chapters proposed for adoption

Rinderpest: Section C.2.2.2 Requirements for substrates and media, lines 489‒490 change: “and originate from countries free from bovine spongiform encephalopathy” to “and originate from countries with negligible risk of bovine spongiform encephalopathy”

American foulbrood and European foulbrood: Table 1. and footnote: reference to reverse transcription polymerase chain reaction (RT-PCR) amended to PCR (no need for reverse transcription for a bacterial pathogen)

Disease names used in the Terrestrial Animal Health Code texts follow the format “Infection with pathogen name”

BSC will keep existing chapter titles and add Code title in parentheses e.g. Chapter 2.2.2 American foulbrood (Infection of honey bees with Paenibacillus larvae)

names used in the Terrestrial Manual do not follow this format, for the fact that the Terrestrial Manual covers diseases rather than infections

Discrepancy between the Terrestrial Code and the Terrestrial Manual

2. Reference Laboratories and Collaborating Centres

Activities

Reference Laboratories

Collaborating Centres Total

Number 252 49 301

Countries 39 26 45*Diseases/

Topics 118 46 ˗

Experts 188 ˗ ˗

OIE Reference Laboratories and Collaborating Centres in 2015

*Countries hosting both Referece Laboratories and Collaboratiing Centres are not counted twice.

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

1. Tests in use

2a. Production of OIE recognised standard reference reagents

2b. Supply of standard reference reagents

3. Production/supply of diagnostic reagents other than OIE-approved

4. Production of vaccines

5. Supply of vaccines

6. Development of new diagnostic methods

7. Development of new vaccines

8. Provision of diagnostic testing

9. Provision of expert advice in technical consultancy

10. Participation in international scientific collaborative studies

11. Collection of epizootiological data

12. Dissemination of epizootiological data

13. Method of dissemination of information

14. Provision of scientific and technical training

15. Maintenance of quality management system according to int'l standards

16. Accreditation by an international accreditation body

17. Maintenance of biosafety and biosecurity

18. Organisation of international scientific meetings

19. Participation of international scientific meetings

20. Exchange information with other OIE labs

21. Proficiency testing with other OIE labs

22. Collaboration with other OIE laboratories for same disease

23. Proficiency testing labs other than OIE labs

24. Provision of consultant expertise

97%

47%

11%

67%

5%

3%

20%

3%

57%

67%

63%

72%

71%

94%

58%

81%

67%

95%

15%

67%

81%

43%

34%

60%

45%

2015 OIE Reference Laboratory Activities

0% 20% 40% 60% 80% 100%

1. Activities within the sphere of competence

2. International harmonisation of regulations

3. Maintenance of a network in same specialty

4. Maintenance of a network in other disciplines

5. Provision of consultant expertise

6. Provision of scientific and technical training

7. Organisation of international scientific meetings

8. Coordination of scientific and technical studies

100%

86%

86%

66%

91%

91%

39%

93%

Activities of Collaborating Centres in 2015

OIE Reference Laboratories

19

Applications should be submitted 45 days before the date scheduled for the meetings of the relevant Commission (Biological Standards Commission or Aquatic Animal Health Standards Commission)

Applications comprise the information requested in all 17 points in the guidelines for applicants

Applications must be no longer than 15–20 pages in A4 format in one of the official languages of the OIE (English, French or Spanish)

All information available on-line at: http://www.oie.int/en/our-scientific-expertise/reference-laboratories/guidelines-for-applicants/

New guidelines for applicants (May 2016)

No9,41%

ISO 1702573,76%

In preparation to achieve ISO 

1702513,86%

System equivalent to ISO 170252,97%

No10,45%

ISO 1702565,17%

In preparation to achieve ISO 

1702520,40%

System equivalent to ISO 170253,98%

Maintenance of quality management system certified according to Int’l Standards

2014* Based on reports submitted as of 12 May 2016

(202 out of 209 have submitted)

Terrestrial Animals

2015* Total of 199 out of 206 have submitted

De-listing of Reference Centres

February 2016: Biological Standards CommissionCritical points for initial evaluation of

performance i) lack of submission of an annual report ii) no progress or explanation provided on achievement of accreditation to

the ISO 17025 or equivalent quality management system in their diagnostic laboratories.

An OIE Reference Laboratory scoring negatively against these points could be deemed to be failing to fulfil the Terms of Reference and could progress down the pathway towards potential de-listing

Commission will continue discussions and develop a standard operating procedure

21

Reference Laboratories and Collaborating Centres: update

Three Reference Laboratories and one Collaborating Centre requested to be removed from list:

Echinococosis/hydatidosis (Japan) Paratuberculosis (Australia) Theileriosis (Belgium)

Research and Training in Population Animal Health Diagnosis and Surveillance Systems (Denmark)

New OIE Reference Laboratories recommended for adoption

Disease Institution Expert

Avian chlamydiosis and Enzootic abortion of ewes (ovianchlamydiosis)

Animal Health Laboratory, Bacterial Zoonoses Unit, ANSES, Maisons-Alfort, France

Dr KarineLaroucau

Foot and mouth disease

Animal and Plant Quarantine Agency, Ministry of Agriculture, Food and Rural Affairs, Gyeongsangbuk-do, Korea (Rep. of)

Dr Jong-HyeonPark

Q fever National Veterinary Research Institute, Dept of Cattle and Sheep Diseases, Pulawy, Poland

Dr Krzysztof Niemczuk

Bovine spongiformencephalopathyand scrapie

Istituto Zooprofilattico Sperimentale del Piemonte Liguria e Valle d’Aosta(IZSPLVA), Torino, ITALY

Dr Cristina Casalone

New OIE Reference Laboratories recommended for adoption

Disease Institution Expert

Brucellosis (B.abortus and B. melitensis)

National institute of Animal Health, Bangkok, Thailand

Dr MonayaEkgatat

Porcine reproductive and respiratory syndrome

Veterinary Diagnostic Laboratory, China Animal Disease Control Center, Beijing, China

Dr Kegong Tian

Rinderpest National Reference Laboratory for Rinderpest, Exotic Disease Research Division, NIAH, Tokyo, Japan

Dr Kazuo Yoshida

Highly pathogenic avian influenza and Newcastle disease

National Agricultural Laboratory, Campinas, Brazil

Dr DilmaraReischak

Replacement experts at OIE Reference Labs

Disease Country Former expert Replaced by

Bluetongue Australia Dr Peter Daniels Dr Debbie Eagles

Bovine Brucellosis Korea Dr Suk-chan Jung Dr Moon Her

Chronic wasting disease and scrapie

Canada Dr Aru Balachandran

Dr Gordon Mitchell

Foot and mouth disease

Argentina Dr Eduardo Maradei

Dr Andrea Pedemonte

Heartwater France Dr Dominique Martinez

Dr Nathalie Vachiéry

Replacement experts at OIE Reference Labs

Disease Country Former expert Replaced by

Hendra and Nipah virus disease

Australia Dr Peter Daniels Dr Kim Halpin

Lumpy skin disease, sheep & goat pox

UK Dr EevaTuppurainen

Dr Pip Beard

Marek’s disease USA Dr Aly Fadly Dr John Dunn

Rift Valley and Crimean-Congo haemorrhagicfever

France Dr Michele Bouloy Dr Noel Tordo

Replacement of expert of OIE Reference Labs

Disease Country Former expert Replaced by

Echinococcosis/hydatidosis

Morocco Prof. AllalDakkak

Dr Hamid Sahibi

Contagious bovine pleuropneumonia

Italy Dr Attilo Pini Dr Massimo Scacchia

Leptospirosis Netherlands Dr Marga Goris

Avian chlamydiosis and Enzootic abortion (ovine chlamydiosis)

Germany Dr Konrad Sachse

Dr Christiane Schnee

Laboratory Twinning programme is functioning well

Contribute to improve the global disease control capacity

Countries in all five OIE regions are benefiting

Demand and interest remains high

As monitoring and evaluation process, four randomly selected twinning projects audited in 2015‒2016

Status May 2016

32 projects completed32 projects underway11 projects pending (“in the pipeline”)

Most popular topicsAvian influenza and Newcastle disease Brucellosis Rabies Foot and mouth disease

Contribution of twinning to OIE Reference Centre network

Adopted (May 2012) RABIES ‒ Changchun Veterinary Research Institute, China (People’s Rep. of) AVIAN MYCOPLASMOSIS ‒ National Centre for Animal and Plant Health, Cuba CONTAGIOUS BOVINE PLEUROPNEUMONIA (CBPP) ‒ National Veterinary Laboratory,

Botswana

Adopted (May 2014) Infectious salmon anaemia ‒ Aquaculture Pathology Laboratory, Chile OIE Collaborating Centre for Veterinary Epidemiology and Public Health ‒ China

Animal Health and Epidemiology Centre (CAHEC), China (People’s Rep. of)

Proposed for adoption (May 2016) BRUCELLOSIS ‒ National Institute of Animal Health, Thailand AVIAN INFLUENZA ‒ Laboratório Nacional Agropecuário em Campinas – Lanagro-SP,

Brazil NEWCASTLE DISEASE ‒ Laboratório Nacional Agropecuário em Campinas – Lanagro-

SP, Brazil

3. Ad hoc Groups (AHG)

Activities

Vaccine Banks

Revised Terrestrial Manual chapter to make more universally applicable. Disease-specific examples removed; requirements defined in OIE Standard chapters replaced by references to those standards

Terms defined in OIE Terrestrial Code were used to replace wording describing same concepts

Revised introduction, clarified definition of a vaccine bank to include antigens

Clarified aspects such as types of banks and selection of vaccines for a bank

Considered criteria for determining quantities of vaccine in a bank

Discussed acquisition and storage of vaccines or antigens

Considered deployment planning and management by international organisations

Replacement of International Standard Bovine Tuberculin

Existing stocks of international standard bovine tuberculin (BIS) are 30 years old and getting low

AHG recommended new BIS should be evaluated and calibrated then endorsed by BSC

Current BIS should be used sparingly as primary reference preparation

AHG members should oversee implementation of study

AHG may convene again to monitor progress

High Throughput Sequencing, Bioinformatics and Computational Genomics (HTS-BCG)

AHG to assess OIE pathogen genomics platform project and detail steps needed for implementation

Goals:

Assessment of an OIE Platform for the collection and management of genomic sequences in animal health

Define standards for uploaded sequence information

Practical recommendations on how to integrate Platform into the next version of WAHIS (World Animal Health Information System)

High Throughput Sequencing, Bioinformatics and Computational Genomics (HTS-BCG)

Recommendations:

Appointment of full-time Project Manager

AHG to provide guidance and support to Project Manager

Once technical specifications of the project completed, put to tender within the WAHIS project

AHG also reviewed and proposed amendments to the draft Terrestrial Manual chapter on HTS-BCG for consideration by the BSC. Chapter is among the group proposed for adoption

4. International standardisation/ harmonisation

Activities

International Standardisation/Harmonisation

Guidelines for the preparation of antigen standards is progressing. A Ref. Lab. expert will be asked to develop guidelines on preparation and validation of reagents for molecular assays

An OIE Ref. Lab. questionnaire on biobanks indicated many did not have computerised system. The Commission asked that an ad hoc Group on a virtual OIE biobank be convened and proposed Terms of Reference

OIE Register of diagnostic kits –New proposed diagnostic kit for inclusion

Name of the diagnostic kit

Pourquier IIF Taylorellaequigenitalis

Manufacturer IDEXX

Fitness for purpose of the Kit

Fit for the detection of Taylorella equigenitalis bacterial bodies from the swabs of the reproductive tract of stallions and mares for the following purposes:

1. Certify freedom from infection or agent in individual animals or products for trade/movement purposes;

2. Estimate prevalence of infection to facilitate risk analysis (surveys/herd health schemes/disease control);

3. Control of infection in stallions and mares at the start of the breeding season.

OIE Register of diagnostic kits –New proposed diagnostic kit for inclusion

Name of the diagnostic kit BIONOTE Rapid MERS-CoV

Manufacturer BioNote, Inc.

Fitness for purpose of the Kit

Fit for the qualitative detection of MERS-CoV antigens from nasal swab in dromedary camels for the following purposes:

1. Detection of MERS CoV infected herds (herd test) with acutely infected animals with high virus loads;

2. When used as a supplemental test, to estimate prevalence of infection to facilitate risk analysis, e.g. surveys, herd health schemes and disease control programmes.

OIE Register of diagnostic kits –Renewal

Name of the diagnostic kit Check&Trace Salmonella

Manufacturer Check-Points B.V.

Fitness for purpose of the Kit

Fit for rapid (molecular) confirmation and serotyping of presumptive Salmonella spp. of the following 22 serotypes:

Agona, Anatum, Bredeney, Derby, Dublin, Enteritidis, Hadar, Heidelberg, Indiana, Infantis, Kottbus, Mbandaka, Montevideo, Newport, Paratyphi B, Paratyphi B v Java, Saintpaul, Senftenberg, Tennessee, Typhimurium (and its monophasic variant 4,12:i:), Virchow

Summary: Draft Resolutions

No. 13: Amendments to the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

No. 14: Designation of OIE Reference Laboratories for terrestrial animal diseases

No. 15: Register of diagnostic kits validated and certified by the OIE

Acknowledgements Dr Bernard Vallat

Dr Monique Eloit

Dr Elisabeth Erlacher-Vindel

Ms Sara Linnane

Dr François Diaz

Dr Gounalan Pavade

Dr Min Kyung Park

Prof. Steve Edwards

Thank you for yourattention!