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Original: English

September 2021

REPORT OF THE MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Virtual meeting, 6–10 September 2021

_______

A virtual meeting of the OIE Biological Standards Commission was held from 6 to 10 September 2021. 

1. Welcome and Commission Induction

Dr Stone, Deputy Director General (International Standards and Science) together with Dr Gillian Mylrea, Head 

Standards Department, conducted an induction session at the start of the meeting. This was the final session of 

the Specialist Commission induction programme that had been implemented as part of the Performance 

Management System. In previous months induction sessions had been conducted for new Commission members, 

Presidents and all Commission members and secretariats, to meet each other and share information relevant to 

this new term.

During this induction session, Dr Stone presented for the consideration of members a discussion on managing 

the workload, roles and responsibilities, process innovation, and the performance management system. 

Dr Stone recalled that the February 2021 Commission reports had been produced in two parts, A (texts for 

adoption) and B (texts for comments and information) to ensure early publication of texts that were to be 

proposed for adoption ahead of the virtual General Session. He noted that the OIE will continue with this 

approach in 2022. Dr Stone also recalled that Pre-General Session webinars hosted by Commission members to 

explain the standards being proposed for adoption were well received and will be repeated in the future. Dr Stone 

also encouraged Commission members to conduct webinars in their respective regions for Delegates and relevant 

Focal Points after the September meeting to explain decisions made. He acknowledged that these webinars 

would also provide a good way for members to build their constituency.

Dr Stone emphasised some key points on: managing a heavy workload through collaborative and prioritised 

work programming and the roles and responsibilities of Specialist Commission Bureaus, experts and 

Secretariats; emphasis was placed on the importance of the partnership between the Specialist Commissions and 

the OIE Headquarters Secretariat. Dr Stone recognised the contribution of the three main activities that were 

specific to this Commission namely the update of international standards in the OIE Terrestrial Manual, the 

management of the OIE Reference Centres and the international standardisation of reagents for use in diagnostic 

tests.

Dr Mylrea facilitated a short session on agreed ways of working in which members discussed expectations 

around behaviour and how they would like to work as a group in the coming 3 years. The President also shared 

with the members his expectations for the new term. 

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2 Biological Standards Commission/September 2021

2. Adoption of Agenda

The proposed agenda was presented and adopted. 

The Agenda and List of Participants are given at Annexes 1 and 2, respectively.

3. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

For this Agenda Item, the Commission was joined by Dr Steven Edwards, Consultant Editor of the OIE Manual 

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

3.1. Review of draft chapters received and their endorsement for circulation for first-round Member 

comment

Given that the lists of OIE Reference Laboratories1and Collaborating Centres2are available online, 

where they are kept up to date, the Commission agreed to remove the lists in Part 4 of the Terrestrial 

Manual; these lists rapidly become out of date following publication of each new edition when new 

Reference Centres are adopted or change of experts are approved.

The Commission reviewed 19 draft chapters and approved 17 for circulation, some subject to clarification 

of certain points by the experts, for first-round Member comment and eventual proposal for adoption by 

the Assembly in May 2022. The 17 chapters and a brief summary of the main amendments are:

1.1.8. Principles of veterinary vaccine production: minor amendments to take account of VICH3

guidelines on harmonisation of criteria to waive laboratory animal batch safety testing or 

vaccines for veterinary use.

2.3.4. Minimum requirements for the production and quality control of vaccines: minor 

amendments to take account of VICH guidelines on harmonisation of criteria to waive 

laboratory animal batch safety testing or vaccines for veterinary use.

3.1.4. Brucellosis (infection Brucella abortus, B. melitensis, B. suis): updated technical aspects of 

some of the diagnostic tests; included some information on the disease in camels and wildlife 

species; removed commercial names from test methods.

3.1.6. Echinococcosis (infection with Echinococcus granulosus and with E. multilocularis): had 

been sent for Member comment in September 2020 and was put on hold while the vaccine 

section was expanded. Also made minor editorial amendments to the introduction and the 

diagnostic test sections in response to comments, including information on diagnosis of 

alveolar echinococcosis in dogs.

3.1.x. Mammalian tuberculosis (infection with Mycobacterium tuberculosis complex): thoroughly 

updated by an ad hoc Group. The revision is so extensive that the changes have not been 

marked in the interest of clarity. Broadened the scope from bovine to mammalian 

tuberculosis, including specific information on cattle, goats and camelids. Updated and 

expanded the diagnostic tests section including nucleic acid recognition methods such as 

PCR4and the delayed hypersensitivity test and interpretation of its results in different 

species; added some information on vaccines and updated the section on production of 

tuberculin.

Reviewed a separate Section on production of molecularly-defined antigen for use in skin 

tests. Molecularly-defined antigens are likely to play an important role in the future, for 

example as reagents in laboratory tests such as the interferon-gamma release assay, and 

eventually as skin test antigens to replace tuberculin PPD5, with the possibility of use in a 

1 List available on the OIE website at: https://www.oie.int/en/what-we-offer/expertise-network/reference-laboratories/#ui-id-3

2 List available on the OIE website at: https://www.oie.int/en/what-we-offer/expertise-network/collaborating-centres/#ui-id-3

3 VICH: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products

4 PCR: polymerase chain reaction

5 PPD: purified protein derivative

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Biological Standards Commission/September 2021 3

DIVA6strategy. The Commission agreed that this is an important advance in the diagnosis 

and control of tuberculosis, but felt it is too soon to include in the Terrestrial Manual. The 

Commission would reconsider inclusion of this text once the technology has been fully 

validated (see also agenda item 10.4).

3.1.14. Nipah and Hendra virus diseases: added statements on the zoonotic potential of these viruses 

and the subsequent need to undertake a biological risk assessment, which may lead to a 

decision to avoid serological tests using live virus; updated the tests included in Table 1 Test 

methods available for the diagnosis of henipaviruses and their purpose and their scores;

clarified that molecular methods for agent detection are preferable as front-line tests as they 

carry less risk to the laboratory worker than virus isolation; updated the information on the 

real-time RT-PCR, including primer sequences; added protocol for an indirect ELISA and

blocking ELISA using antigen derived from the Hendra G protein; added a sentence stating 

that a HeV DIVA assay is currently undergoing validation by the OIE Reference Laboratory; 

removed names of commercial reagents, test kits and equipment; updated information on 

candidate experimental vaccines for Nipah virus as well as on the soluble G henipavirus 

vaccine.

3.1.22. Tularemia: minor updates to clarify the text; in Table 1 Test methods available for the 

diagnosis of tularemia and their purpose, changed the score of bacterial isolation for the 

purpose “confirmation of clinical cases” from “+++” to “++” because the organism is highly 

fastidious and will only grow on certain media; also in Table 1 added a new row for the 

conventional PCR as described by Barns et al. (2005)7and indicated that the real-time PCR 

is that of Versage et al. (2003)8; updated the references.

3.2.1. Acarapisosis of honey bees (infestation of honey bees with Acarapis woodi): thorough 

update as the chapter was last adopted in 2008: added new diagrams and Table 1 Test 

methods available and their purpose; fully updated the diagnostic tests section including the 

addition of a new section on PCR, both conventional and real-time, and deleted the section 

on the ELISA9.

3.3.9. Fowl cholera: updated the diagnostic tests section, in particular by adding molecular 

methods, deleting somatic typing and clarifying that animal inoculation is no longer 

recommended; in the vaccine section clarified that it is now known that a killed vaccine 

provides protection only against isolates with the identical or near to identical LPS10

structure; updated the references.

3.3.15. Turkey rhinotracheitis (avian metapneumovirus): updated virus taxonomy, strain 

classification and host range; clarified that avian metapneumovirus (aMPV) does not cause 

infection in humans; added Table 1 Test methods available and their purpose; thoroughly 

updated and reformatted Section C on requirements for vaccines. 

3.8.11. Scrapie: clarified the information on classical and atypical scrapie throughout the chapter;

expanded the information on the influence of PrP genotype on disease susceptibility in goats; 

stressed that the medulla oblongata is appropriate for detection of classical scrapie but for 

detection of atypical scrapie the cerebellum should also be sampled; clarified that

histological examination should not be used as a primary screening or confirmatory test, but 

that it is a valuable research tool; pointed out that some ELISA-based rapid tests have limited 

sensitivity when applied to goat samples and have not been validated for this species and that 

PrP polymorphisms may also affect the performance of immunoassays; updated the links to 

the protocols available from the OIE Reference Laboratories.

6 DIVA: Detection of infection in vaccinated animals

7 BARNS S.M., GROW C.C., OKINAKA R.T., KEIM P. & KUSKE C.R. (2005). Detection of diverse new Francisella-like bacteria 

in environmental samples. Appl. Environ. Microbiol., 71, 5494–5500.

8 VERSAGE J.L., SEVERIN D.D.M., CHU M.C. & PETERSEN J.M. (2003). Development of a multitarget real-time TaqMan PCR 

assay for enhanced detection of Francisella tularensis in complex specimens. J. Clin. Microbiol., 41, 5492-5499.

9 ELISA: enzyme-linked immunosorbent assay

10 LPS: lipopolysaccharide

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4 Biological Standards Commission/September 2021

3.8.13. Theileriosis in sheep and goats (infection with Theileria lestoquardi, T. luwenshuni and 

T. uilenbergi): This is a new chapter in anticipation of the listing of these agents by the OIE.

The Commission agreed to amend the title of chapter 3.4.15. to Theileriosis in cattle

(infection with Theileria annulata and T. parva).

3.9.3. Classical swine fever (infection with classical swine fever virus) (diagnostic section only): 

added text to the summary and introduction on the existence of and difficulties caused by 

persistent infections; included technical updates to the virus isolation test procedure and the 

reverse-transcription PCR; further emphasised the existence of other ruminant pestiviruses 

and the need for reliable differentiation of classical swine fever virus from other pestiviruses; 

updated the section on the ELISA; updated the references.

3.10.1. Bunyaviral diseases of animals (excluding Rift Valley fever and Crimean–Congo 

haemorrhagic fever): updated the taxonomy of this viruses; updated the information in the 

introduction to Schmallenberg virus (SBV) and Nairobi sheep disease virus (NSDV); 

included more recent references to the diagnostic section on Cache Valley virus (CCV), 

Akabane virus (AKAV), SBV and NSDV; updated the vaccine section on SBV.

3.10.4. Cryptosporidiosis: updated the information on differences among species within the genus

Cryptosporidium; revised the description and impact of the disease and its human health risk 

and zoonotic potential; updated the information on transmission, biosafety and biosecurity 

requirements; updated the references.

3.10.6. Mange: minor updates, including addition of preliminary information on molecular methods 

and serology.

3.10.7. Salmonellosis: revised the Sections on the nature and classification of the pathogen, the 

description and impact of the disease, and its zoonotic potential and biosafety and biosecurity 

requirements; in the Section on detection of the agent – culture – updated the information on 

pre-enrichment, selective enrichment and selective plating media; revised the example test 

procedures for isolation of Salmonella from food, feedstuffs, faecal and environmental 

samples and on immunological and nucleic acid recognition methods; stressed that 

attenuation of live vaccines is essential to limit intestinal replication and persistence in the 

animals and environment, but such attenuation is unlikely to have no impact on the vaccinal 

response; updated the references.

The batch of draft chapters will also include three other chapters: contagious equine metritis (see agenda 

item 3.5), glanders and melioidosis (see agenda item 3.6), and foot and mouth disease (see agenda item 

9.2.1) and the glossary (see agenda items 3.2 and 9.1.1i). 

The chapters can be downloaded from the following address: 

http://web.oie.int/downld/Terr_Manual/MAILING_OCT_2021.zip

Members are reminded that they should submit the rationale for all their proposed changes to the texts, 

and include references where relevant for the Commission to consult. Comments should be submitted to 

the Commission’s Secretariat: bsc.secretariat@oie.int The deadline for comments is 15 December 2021.

3.2. Follow-up from pre-General Session webinars 

In preparation for the 88th General Session in May 2021, the Commission had organised three webinars 

to present to interested parties the Terrestrial Manual chapters that would be presented for adoption. 

During one of the webinars, a Member noted that the draft chapter on avian influenza mentioned SPF 

(specific pathogen free) eggs, defined in the glossary, and SAN (specific antibody negative) eggs, not 

defined. To address this omission, the Commission proposes that the following definition of SAN be 

added to the glossary:

• Specific antibody negative (SAN) eggs

Used in relation to animals that have been shown by the use of appropriate tests to be free from antibodies 

to specific avian pathogenic microorganisms, and also eggs derived from these birds. 

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Biological Standards Commission/September 2021 5

3.3. Follow-up from the General Session

3.3.1. Chapter 3.5.8 Equine piroplasmosis

At the General Session in May 2021, Chapter 3.5.8. Equine piroplasmosis had been adopted 

with one abstention from a Member that did not agree with the change in the scoring of the 

IFAT11 and the C-ELISA12 given in column 4 (confirmation of clinical cases) of Table 1 Test 

methods available for the diagnosis of equine piroplasmosis and their purpose from 

“recommended” to “not appropriate for this purpose”.

The Member did not believe that concerns raised about inconsistencies in the text of this chapter 

and Table 1 had been addressed. The Member noted that in Table 1 microscopic examination 

and PCR are recommended for confirmation of clinical cases of equine piroplasmosis, while 

both serological tests (IFAT and C-ELISA) are not appropriate. The reliability of PCR and 

microscopic examination as diagnostic tests depends on the level of parasitaemia. That level is 

highly dynamic and variable, and can even be low in clinical cases when sampling is performed. 

The Member emphasised that a number of studies have highlighted a disparity in results between 

C-ELISA, microscopy and PCR for detection of equine piroplasmosis in both subclinical and

acutely infected horses. The Member maintained that, due to the epidemiology of equine

piroplasmosis, a combination of PCR and serological testing is essential to most accurately

determine an animal’s piroplasmosis status, even in clinical cases. The Member therefore did

not support that serological tests for equine piroplasmosis are listed as “not appropriate” for

confirmation of clinical cases.

The Commission reviewed the comments and the references provided and found that they did 

not substantiate the Member’s arguments. The Commission reiterated that serological assays, 

which are recommended for detecting carrier animals, are not suitable for confirming clinical 

disease as they cannot differentiate between an active infection and a past infection A 

combination of PCR and serological tests is essential to determine whether an animal is free 

from infection.

The Commission is not proposing any further changes to the chapter but invites the Member to 

submit more references to support their position. The Commission would review any new 

information provided.

3.3.2. Chapter 3.4.12 Lumpy skin disease

Also at the General Session, concerns had been raised about the DIVA PCR methods used to 

distinguish vaccine strains from field strains of LSDV13, and the challenges encountered in 

recent years with correctly identifying new recombinant field strains that have emerged in 

certain parts of the world. Correct identification of LSDV strains has wide implications for 

disease notification, country status and international trade. 

The Commission reconfirmed its commitment to addressing as a priority the issue of emerging 

recombinant LSDV strains, their correct diagnosis and notification. To this end, the advice of 

the OIE Reference Laboratories would be sought on how best to address the issue. The 

Biological Standards Commission would also collaborate with the Scientific and Code 

Commissions to best resolve this important problem. 

3.4. Conclusions and recommendations from the OIE Scientific and Technical Review issue on 

diagnostic test validation science

The Commission reviewed the conclusions and recommendations from the recently published volume of 

the OIE Scientific and Technical Review on diagnostic test validation science. Those recommendations 

that concern the OIE Procedure for the Registration of Diagnostic Kits are discussed below (see agenda 

item 6.1.2).

11 IFAT: indirect fluorescent antibody test

12 C-ELISA: competitive enzyme-linked immunosorbent assay

13 LSDV: lumpy skin disease virus

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6 Biological Standards Commission/September 2021

For those concerning the Terrestrial Manual, the Commission agreed:

i) To review and update all the OIE validation chapters and glossary of terms, including Chapter 1.1.6

Principles and methods of validation of diagnostic assays for infectious diseases (see agenda item

3.9).

ii) That a list of OIE validated tests should be published on the OIE Website for end-users similar to

the list of Currently available OIE-approved International Standard Reagents14. To advance this

project, members of the Commission were identified who would develop a template for the

validation data that would be requested of applicants wishing to add their test to the list. It would

need to be agreed how far a test needs to advance in the OIE validation pathway to be considered

as validated to the OIE standard. The Commission would review the template at its next meeting in

February 2022.

iii) That a new section would be added to all disease chapters as they are revised to describe the rationale

behind the selection of tests for different purposes given in Table 1 Test methods available and their

purpose. Eventually, links could be provided to the validation reports for those tests validated to the

OIE standard mentioned in point ii above. Members of the Commission were identified who would

develop a template for this new section. The Commission would review the template at its next

meeting in February 2022.

3.5. Review of a validation dossier for a real-time PCR method for detection of Taylorella equigenitalis

directly from swabs, and proposed text for Chapter 3.6.2 Contagious equine metritis

In September 2017, a validation dossier had been submitted for a real-time PCR method for detection of 

Taylorella equigenitalis directly from swabs. The Commission requested the OIE Reference Laboratories 

for contagious equine metritis to evaluate the dossier. While reviewing the dossier, the experts agreed 

that before approving a PCR as a recommended test, its reproducibility in laboratories other than the one 

of origin must be assured. They decided to investigate the reproducibility of the submitted test along with 

another real-time PCR that was already in the Terrestrial Manual (Wakeley et al., 200615), and to 

compare both PCRs with culture techniques.

For this meeting, the experts submitted a metanalysis of the published data directly comparing culture 

and PCR in field samples, and a summary of PCR and culture ring trial results in a number of laboratories, 

including specifically designed ring trial studies on the use of the two named real-time PCRs in a number 

of laboratories using a panel of DNA extracts derived from swabs of field cases of contagious equine 

metritis and a panel of swabs prepared in the laboratory to mimic field swabs. 

The Commission reviewed the documents and agreed with the experts recommendation to include the 

two real-time PCR methods in the Terrestrial Manual chapter. The revised chapter is included in the 

batch of chapters that have been approved to be circulated for first-round Member comment (see agenda 

item 3.1).

3.6. Request to update Chapter 3.6.11 Glanders and melioidosis to include a new recombinant double 

antigen-based ELISA 

The OIE Reference Laboratory in Germany had submitted a request to include a recombinant double 

antigen-based ELISA for the detection of antibodies specific for Burkholderia mallei in the Terrestrial 

Manual chapter on glanders and melioidosis. The request included a published reference to the validation 

study for this assay (Elschner et al., 202116). The experts believe that considering the comparable 

sensitivities of CFT17 (96.5%) and this ELISA (98.1%), the ELISA is a suitable confirmatory test and a 

realistic alternative for serological testing of horses for trade or movement. 

14 https://www.oie.int/en/what-we-offer/veterinary-products/#ui-id-4

15 WAKELEY P.R., ERRINGTON J., HANNON S., ROEST H.I.J., CARSON T. HUNT B. & HEATH P. (2006). Development of a real 

time PCR for the detection of Taylorella equigenitalis directly for the genital swabs and discrimination from Taylorella 

asinigenitialis. Vet. Microbiol., 118, 247–254.

16 ELSCHNER M.C., MELZER F., SINGHA H., MUHAMMAD S., GARDNER I. & NEUBAUER H. (2021). Validation of a Commercial 

Glanders ELISA as an Alternative to the CFT in International Trade of Equidae. Front. Vet. Sci., 8, 628389. 

doi:10.3389/fvets.2021.628389

17 CFT: complement fixation test

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Biological Standards Commission/September 2021 7

The Commission reviewed the reference and accepted the experts’ request. It is proposed to add the assay 

to Table 1 Test methods available for the diagnosis of glanders and their purpose, and to section B.3.2 

Enzyme-linked immunosorbent assays of the chapter. The revised chapter is included in the batch of 

chapters that have been approved to be circulated for first-round Member comment (see agenda item 3.1).

3.7. Request to update Chapter 3.1.1 Anthrax to include a new easier to produce Bacillus anthracis

capsule stain

The Commission had received a request to include a new capsule stain in the Terrestrial Manual chapter 

on anthrax as it is quicker to make and thus more readily available and convenient. The request and 

supporting references would be submitted to the OIE Reference Laboratories for their opinion. Should 

the method be validated it could be included in the next revision of the chapter.

3.8. Including OIE Terrestrial Manual chapters in national regulations: requirement to mention the 

most recently adopted version of the OIE Standard

The OIE had received a request from a vaccine manufacturer for the 2012 edition of the Terrestrial 

Manual chapter on biosafety and biosecurity. The reason given was that the 2012 edition is specifically 

mentioned in national adopted GMP18 regulations. The OIE and the Commission would like to reiterate 

that only the most recently adopted version of an OIE standard is the version in vigour. When referencing 

OIE Standards in national regulations, rather than giving a specific year, the regulations should refer to 

“the most recently adopted version of the OIE standard”. This is all the more important for the chapter 

on biosafety and biosecurity as the OIE recommendations have moved on from defining risk groups 

(2012 edition) to a risk analysis approach (current edition).

3.9. Review of Terrestrial Manual status: selection of chapters for update in 2022/2023 review cycle

The Commission examined the status of chapters that had previously been identified for update in the 

2021/2022 review cycle but had not been received. The Commission decided to add to the list chapters 

that had last been updated in 2017. The following chapters have been identified for update in 2022/2023:

1.1.2. Collection, submission and storage of diagnostic specimens (last adopted May 2013)

1.1.4. Biosafety and biosecurity: Standard for managing biological risk in the veterinary 

laboratory and animal facilities (last adopted May 2015)

1.1.5. Quality management in veterinary testing laboratories (last adopted May 2017)

1.1.6. Principles and methods of validation of diagnostic assays for infectious diseases (last 

adopted May 2013)

1.1.7. Standards for high throughput sequencing, bioinformatics and computational genomics

(last adopted May 2016)

1.1.9. Tests for sterility and freedom from contamination of biological materials intended for 

veterinary use (last adopted May 2017)

1.1.10. Vaccine banks (last adopted May 2016)

2.1.3. Managing biorisk: examples of aligning risk management strategies with assessed biorisks

(last adopted May 2014)

2.2.1. Development and optimisation of antibody detection assays (last adopted May 2014)

2.2.2. Development and optimisation of antigen detection assays (last adopted May 2014)

2.2.3. Development and optimisation of nucleic acid detection assays (last adopted May 2014)

2.2.4. Measurement uncertainty (last adopted May 2014)

2.2.5. Statistical approaches to validation (last adopted May 2014)

2.2.6. Selection and use of reference samples and panels (last adopted May 2014)

2.2.7. Principles and methods for the validation of diagnostic tests for infectious diseases 

applicable to wildlife (last adopted May 2014)

2.2.8. Comparability of assays after minor changes in a validated test method (last adopted May 

2016)

2.3.1. The application of biotechnology to the development of veterinary vaccines (last adopted 

May 2010)

18 GMP: good manufacturing practices

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8 Biological Standards Commission/September 2021

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

facility (last adopted May 2016)

2.3.5. Minimum requirements for aseptic production in vaccine manufacture (last adopted May 

2016)

3.1.5. Crimean–Congo haemorrhagic fever (last adopted May 2014)

3.1.18. Rift Valley fever (infection with Rift Valley fever virus) (last adopted May 2016)

3.1.20. Trichinellosis (infection with Trichinella spp.) (last adopted May 2017)

3.2.2. American foulbrood of honey bees (infection of honey bees with Paenibacillus larvae)

(last adopted May 2016)

3.2.3. European foulbrood of honey bees (infection of honey bees with Melissococcus plutonius)

(last adopted May 2016)

3.2.4 Nosemosis of honey bees (last adopted May 2013)

3.3.6. Avian tuberculosis (last adopted May 2014)

3.3.8. Duck virus hepatitis (last adopted May 2017)

3.3.13. Marek’s disease (last adopted May 2017)

3.4.1. Bovine anaplasmosis (last adopted May 2015)

3.4.7. Bovine viral diarrhoea (last adopted May 2015)

3.4.11. Infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (last adopted May 

2017)

3.6.9. Equine rhinopneumonitis (infection with equid herpesvirus-1 and -4) (last adopted May 

2017)

3.6.10. Equine viral arteritis (infection with equine arteritis virus) (last adopted May 2013)

3.8.1. Border disease (last adopted May 2017)

3.8.2. Caprine arthritis/encephalitis and Maedi-visna (last adopted May 2017)

3.8.12. Sheep pox and goat pox (last adopted May 2017)

3.9.7. Influenza A virus of swine (last adopted May 2015)

3.9.9. Teschovirus encephalomyelitis (last adopted May 2017)

3.9.10. Transmissible gastroenteritis (last adopted May 2008)

3.10.4. Infection with Campylobacter jejuni and C. coli (last adopted May 2017)

3.10.8. Toxoplasmosis (last adopted May 2017)

3.10.10. Verocytotoxogenic Escherichia coli (last adopted May 2008)

The OIE Reference Laboratory or other experts, where necessary, would be asked to undertake the 

revisions.

4. OIE Reference Centres

4.1. Applications for OIE Reference Centre status

The Commission recommended acceptance of the following application for OIE Reference Centre status:

OIE Reference Laboratory for Paratuberculosis

National Reference Centre for Paratuberculosis, Istituto Zooprofilattico Sperimentale della 

Lombardia e dell’Emilia Romagna, Sede Territoriale di Piacenza, Strada della Faggiola 1, 29027 

Gariga di Podenzano (PC), ITALY

Tel.: (+39-0523) 52.42.53

E-mail: matteo.ricchi@izsler.it; piacenza@izsler.it Website: www.izsler.it

Designated Reference Expert: Dr Matteo Ricchi.

OIE Reference Laboratory for Rift Valley fever 

CIRAD, Campus international de Baillarguet, TA A15/E, 34398 Montpellier Cedex 5, FRANCE

Tel.: (+33-4) 67.59.38.34

E-mail: catherine.cetre-sossah@cirad.fr website: https://www.cirad.fr

Designated Reference Expert: Dr Catherine Cetre-Sossah.

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OIE Reference Laboratory for avian mycoplasmosis (Mycoplasma gallisepticum, M. synoviae)

Avian Medicine Laboratory, Istituto Zooprofilattico Sperimentale delle Venezie, Via Bovolino 1/C, 

37060 Buttapietra (VR) ITALY

Tel.: (+39-045) 50.02.85

E-mail: scatania@izsvenezie.it website: www.izsvenezie.com

Designated Reference Expert: Dr Salvatore Catania.

OIE Collaborating Centre for Camel Diseases 

Abu Dhabi Agriculture and Food Safety Authority, P.O. Box: 52150, Mohammed Bin Zayed City, 

Capital Mall, Abu Dhabi, UNITED ARAB EMIRATES

Tel.: (+971-2) 818.10.08

E-mail: vld.office@adafsa.gov.ae Website: https://www.adafsa.ae

Contact Point: Dr Salama Suhail Mohammed Al Muhairi.

OIE Collaborating Centre for Veterinary Medicinal Products for Eastern Europe, Central Asia and 

Transcaucasia

Federal State Budgetary Institution “The Russian State Center for Animal Feed and Drug 

Standardization and Quality”, Zvenigorodskoye shosse, 5, 123022, Moscow, RUSSIA

Tel.: (+7-499) 941.01.51 ext. 643

E-mail: intcoopdiv@vgnki.ru; kanc@vgnki.ru website: http://en.vgnki.ru/

Contact Point: Dr Vasinina Gryciuk.

The Commission is aware that there is an existing OIE Collaborating Centre for the same topic in the 

Europe region, but proposed that for linguistic and cultural reasons, the circumstances justified an 

exceptional designation as a stand-alone Centre in the sub-region.

In February 2021, an application had been received for an OIE Reference Laboratory for African horse 

sickness. Amongst other information, the applicant had been asked to provide more detailed information 

on their experience in standardisation and validation of diagnostic tests. The Commission found that the 

response received did not provide convincing evidence of established experience in standardisation and 

validation of diagnostic tests for African horse sickness and thus did not accept the application at this 

time. 

Finally, an application had been received for an OIE Reference Laboratory for Crimean–Congo 

haemorrhagic fever. Although the application was of very high quality, the Commission noted that it

included only two publications. Before a decision can be taken the applicant would be asked to submit a 

complete publications list for review at the February 2022 meeting.

4.2. Changes of experts at OIE Reference Centres 

The Delegate of the Member concerned had submitted to the OIE the following nomination for changes 

of experts at OIE Reference Laboratories. The Commission recommended their acceptance: 

Babesiosis

Dr Valeria Blanda to replace Dr Santo Caracappa at the Istituto Zooprofilattico Sperimentale della 

Sicilia (IZSSi), Palermo, ITALY

Bovine tuberculosis

Dr Jason Sawyer to replace Prof. Glyn Hewinson at the Animal and Plant Health Agency, 

Weybridge, UNITED KINGDOM

Infestation with Aethina tumida (small hive beetle); Infestation of honey bees with Tropilaelaps spp.

Dr Stéphanie Franco to replace Dr Marie-Pierre Chauzat at Anses, Laboratoire de Sophia Antipolis, 

FRANCE

Foot and mouth disease

Dr Livio Heath to replace Dr François Maree at the Onderstepoort Veterinary Institute, SOUTH 

AFRICA

The Commission reviewed seven additional nominations for changes of experts at OIE Reference 

Laboratories and based on the information provided felt that none could fulfil the expectations of an OIE 

Expert. The Commission reiterated that OIE designated experts must be a leading and active researcher, 

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10 Biological Standards Commission/September 2021

must have experience in the application of diagnostic techniques for the disease in question and must be 

able to provide adequate evidence of expertise (e.g. a body of published papers in peer-reviewed journals) 

so as to be able to provide sound scientific advice on all aspects of the disease to Members. The Reference 

Laboratories would be asked to either resubmit a strengthened curriculum vitae or to propose a different 

expert. 

4.3. Review of new and pending applications for laboratory twinning

As of September 2021, 66 projects have been completed, 32 projects are underway and 1 is awaiting 

funding before beginning.

One Laboratory Twinning project proposal was presented for the Commission’s review:

i) United Kingdom – Georgia for Mycoplasmosis: the Commission supported the technical contents

of this project.

4.4. Inconsistencies among OIE Reference Laboratories in results obtained using the real-time RTPCR for African horse sickness

The Commission reviewed a request from an OIE Reference Laboratory for AHS19 to facilitate a 

discussion among laboratories regarding inconsistencies in the detection of AHS virus positive animals 

in a quarantine station by the real-time RT-PCR method and the implications this has for trade or free 

status. The Reference Laboratory raised concerns that inconsistencies in laboratory results may lead to 

confusion among countries in terms of import status, unpredictable responses to finding unexpectedly 

positive samples in pre- or post-import testing and unnecessary delays in the movement of horses.

The Commission considered it to be a serious issue: laboratories need to have a harmonised diagnostic 

approach. The Commission therefore recommended that the OIE facilitate a discussion between all the 

interested parties including all three OIE Reference Laboratories for AHS, the concerned quarantine 

station, and a representative of the Commission.

● Reference Laboratories – implementation of the SOPs20

4.5. Follow-up February meeting: further feedback from the Laboratories that are not complying with 

the key ToR according to their 2018 annual report

The Commission reviewed the feedback received from two Reference Laboratories that were not 

complying with key performance criteria according to their 2018 annual reports. 

One Reference Laboratory was no longer permitted to work on the disease in question as the country was 

free from it responded that it is working closely with the national Veterinary Services to resolve this issue 

and to continue performing its function as an OIE Reference Laboratory. However due to the COVID-19

pandemic, the discussion could not move forward in a timely manner. The Reference Laboratory 

therefore requested an extension to solve this issue. The Commission accepted this request: the Reference 

Laboratory would be asked to submit evidence that it had resolved the problem for review at the next 

meeting in February 2022, failing this the Reference Laboratory’s designation could be revoked in 

accordance with Article 9 of the Internal rules for OIE Reference Centres.

The second Reference Laboratory had again failed to submit a certificate of accreditation to ISO 17025 

or equivalent quality management system. The Reference Laboratory reported that the institution’s 

accreditation assessment process was complete. The accreditation body had requested some corrections, 

which has been supplied but because of the Covid-19 pandemic situation there would be a delay before 

the accreditation body could assess the Reference Laboratory’s response. The Commission proposed that 

the Reference Laboratory be contacted regularly over the coming months for an update on its

accreditation status. If the Reference Laboratory fails to submit an accreditation certificate by the next 

meeting in February 2022, it’s designation will be revoked in accordance with Article 9 of the Internal 

rules for OIE Reference Centres.

19 AHS: African horse sickness

20 SOPs: Standard Operating Procedure

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Biological Standards Commission/September 2021 11

4.6. Feedback from the Laboratories that are not complying with the key ToR according to 2019 annual 

report

The Commission accepted the explanations provided by one Reference Laboratory and noted the efforts 

taken to slightly increase the level of activity in 2020. The Commission expected the Reference 

Laboratory to further increase its diagnostic activities in 2021 by contacting other national laboratories 

in the region to offer diagnostic services.

4.7. In-depth review of all annual reports for activities in 2020

The Commission reviewed the performance of all the OIE Reference Laboratories by an in-depth analysis 

of the annual reports submitted in 2020 to ensure that each laboratory is fulfilling the ToRs21 to the benefit 

of OIE Members and performance criterion iii) of the Procedures for Designation of OIE Reference 

Laboratories (the SOPs).

The Commission identified 53 Reference Laboratories that had a low level of activities: many cited the 

impact of the Covid-19 pandemic situation that had led to the disruption of the laboratory’s activities. 

The Commission agreed that the pandemic has negatively impacted the performance of OIE Reference 

Laboratories in 2020 and placed all of the low performance laboratories in a watch list for follow up at

the next annual report review cycle. 

Three OIE Reference Laboratories had not submitted annual reports for 2020: the laboratories for 

Crimean–Congo haemorrhagic fever and Rift Valley fever had withdrawn their designations and the 

Member in question had submitted new applications (see agenda item 4.1). The OIE Reference 

Laboratory for babesiosis did not have a designated expert in 2020, but had submitted a nomination for 

a replacement expert for review at this meeting (see agenda item 4.2).

● Collaborating Centres – implementation of the SOPs

4.8. Follow-up February meeting: feedback on the mapping exercise for the existing Centres against

the list of main focus area and specialties

At the February 2021 meeting, one Centre in the Americas region that had been categorised under focus

area ‘Training and education’ but was reporting a broad range of activities under all focus areas had been

asked to consider dividing up into separate Centres for each focus area. The Centre understood this

requirement and preferred to remain as one OIE Collaborating Centre. To this end the Centre proposed

to change its focus area to ‘Animal Health Management’ and to report only relevant activities. The Centre

also provided a rationale for retaining its title. The Commission accepted the Centre’s new focus area and

retention of its title.

In the Europe region, two Centres in the same country with similar titles and core activities had been

asked to consider joining together to form one Collaborating Centre consortium. Rather than forming one

joint Centre, the Centres proposed that they remain separate with one focusing on viral diseases and the

other on bacterial diseases. The Commission accepted this proposal, and the title of the Centres will be

adjusted accordingly. One of these two Centres also had the focus area ‘food safety’ in its title and remit.

The Centre will be invited to establish a separate stand-alone Collaborating Centre on Food Safety under

the focus area ‘Animal production and food safety’. The Commission is aware that there is an existing

OIE Collaborating Centre for the same topic in the Europe region, but proposed that for linguistic and

cultural reasons, the circumstances justified an exceptional designation as a stand-alone Centre in the

sub-region.

4.9. Follow-up February meeting: feedback from the Centres that are not complying with the key ToR

according to 2019 annual report

One Centre that had shown a low level of activity in its 2019 annual report had reassured the Commission

at that time that it would improve its performance in 2020. However, the Centre had not submitted a

report for activities in 2020. Furthermore, the Centre had not submitted a 5-year work plan for activities

in 2020–2024. The Centre will be sent a letter requesting that it submit the 5-year work plan as soon as

21 ToRs: Terms of Reference

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12 Biological Standards Commission/September 2021

possible. The Centre will also be reminded that non-submission of its annual report means that it was not 

complying with the performance criteria, which could lead to the delisting procedures being initiated.

4.10. Follow-up September: feedback on the review of the 5-year work plans received from 

Collaborating Centres:

As a follow up from previous meeting, the Commission reviewed the feedback received from two Centres 

on the submitted 5-year work plans. 

One Centre clarified that the activities planned for the first half of 2020 and delayed due to Covid-19 

pandemic situation will be re-programmed later when the situation improves; the Commission accepted 

this explanation. One Centre that had submitted an incomplete 5-year work plan was asked to correct and 

update the information and include authorisation signature. The Commission reviewed the re-submitted 

work plan and noted that the information provided in Section 5.1 Planned activities covered what had 

already been achieved not what the Centre intends to accomplish over the next 5 years. The Centre will 

be asked to provide more details listing specific activities they intend to carry out in the future.

The Commission reviewed three newly submitted 5-year work plans and approved the range of activities 

proposed by two of the Centres and their relevance to the identified main focus areas and specialties. The 

third Centre had not provided any information for Section 5.1 Planned activities or for Section 5.2

Measurement of benefits, both of which are critical and mandatory for the work plan. The Centre will be 

asked to re-submit the work plan to include these necessary details.

Two Collaborating Centres that had still not submitted a 5-year work plan would be sent reminders; the 

Centres would be advised that a 5-year work plan is mandatory to comply with the SOPs, and nonsubmission could lead to the delisting procedures being initiated.

4.11. In-depth review of all annual reports for activities in 2020

As for the Reference Laboratories, the Commission also undertook an in-depth analysis of all the annual 

reports of the Collaborating Centres submitted in 2020 to ensure fulfilment of the ToRs.

The Commission identified six Collaborating Centres that were not complying with the performance 

criteria. The Centres concerned would be informed of the outcome of the review and asked to provide an 

explanation of their situation and possible reasons for the lack of activities; the Delegate will be in copy 

of all correspondence. The Commission was particularly concerned with some of the Centres where the 

activities are minimum, nationally driven without international collaboration, quite narrowly focused and 

not covering a broad range of activities as described in the ToR.

The Commission expressed its appreciation for the continued support and expert advice given to the OIE 

by the Reference Centres.

● Reference Centre networks

4.12. Update on the three identified Reference Laboratory networks (Rabies, PPR and ASF) 

The Commission was briefed on the progress of the recently launched three OIE Reference Laboratory 

networks for rabies, PPR22 and ASF23. All three networks are up and running and have held regular virtual 

meetings to initiate each network’s activities. 

The rabies Reference Laboratories network (RABLAB) conducted a survey to identify the core activities 

and capacities of the participating laboratories along with a gap analysis. The network’s logo was agreed 

on and finalised. A technical discussion was held among network members on a proposal to reduce the 

post-titre waiting period for imported dog from 90 days to 30 days. The network’s advice will be provided 

to the appropriate Specialist Commissions for further follow up.

The PPR Reference Laboratories network developed the activities plan for 2021. The network discussed 

a list of potential key national laboratories from all the regions of the world that could be invited as 

22 PPR: peste des petits ruminants

23 ASF: African swine fever

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Biological Standards Commission/September 2021 13

additional members. These members were asked to provide more information on their PPR work and to 

agree to participate in the network activities. The logo of the network was drafted. The detailed structure 

of the network website was finalised after various consultations on design, content and responsibilities. 

The network provided expertise for the call for tender to the OIE PPR vaccine bank. The network’s first 

workshop bringing together PPR Reference Laboratories along with selected national laboratories will 

be held in November 2021.

The ASF Reference Laboratories network met to gain an understanding of the impact of the low virulent 

strains circulating in China (People’s Rep. of), their consequences for Asia and other regions and how the 

network could support the Members to address any changing risk. As a follow up action, the network 

agreed on the need to develop an ‘ASF laboratory diagnosis protocol’ that would be valuable for Members. 

Subsequently the experts held meetings to discuss and collect various laboratory protocols with the aim 

of developing a summary of diagnostic tools for the detection of ASF infection in different scenarios that

will be finalised by the end of the year for publication in coordination with the FAO24. The network is 

also working on developing a concept note for a centralised ASF virus genetic sequence database detailing 

the needs, expectations and requirements for deposit of sequences. The network shared experiences and 

participated in the discussion to curb the ongoing spread of ASF in the Americas. 

The Commission appreciated the efforts of all the three network Reference Laboratories in establishing 

the networks to carry out a variety of activities intended to accelerate progress towards global strategic 

control and eradication programmes through scientific collaboration.

5. Ad hoc Groups

● Update on activities of ad hoc Groups

5.1. Ad hoc Group on Replacement of the International Standard Bovine Tuberculin (ISBT): update

on the replacement ISBT

This ad hoc Group has been meeting for the past 6 years, with the primary task to develop a new

international standard for bovine tuberculin (ISBT). This was in recognition that the present bovine

international standard (BIS), developed and maintained by WHO25, was running out and deteriorating.

WHO agreed that it would be appropriate for OIE to develop the new standard.

The Commission was informed that the Group would meet virtually in October to discuss new data on

the candidate tuberculin following further research that had been undertaken. The Group is confident that

it will be in a position to finalise the report by December in time to present it to the Commission at its

next meeting in February 2022. The project is still on target for presentation of the replacement ISBT for

adoption by resolution in May 2022.

5.2. Ad hoc Group on the revision of Terrestrial Code chapters regarding the collection and processing

of semen of animals, 9 November 2020 to 15 January 2021

The Commission was updated on the work of the ad hoc Group on the revision of Terrestrial Code

chapters regarding the collection and processing of semen of animals, which convened for the second

time between May and July 2021 and developed draft text for Chapter 4.6. General hygiene in semen

collection and processing centres.

Further information on the work of the ad hoc Group as well as the next steps may be found in the

September 2021 report of the Code Commission.

5.3. Ad hoc Group on Sustainable Laboratories

The OIE convened a meeting of the ad hoc Group on Sustainable Laboratories virtually in June 2021. In

2019, the Group established a working definition of a sustainable laboratory network as “a network of

laboratories that can maintain appropriate safety, security, and quality on a path towards compliance with

OIE International Standards, taking into account social, environmental, and economic factors in its day

to day operations for the benefit of the health system.” The Group took stock of the work done to date in

24 FAO: Food and Agriculture Organization of the United Nations

25 WHO: World Health Organization

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14 Biological Standards Commission/September 2021

three key areas – economic indicators for laboratory sustainability, mission methodology, and data – and 

agreed on next steps for each area.

The report of the virtual meeting of the ad hoc Group on Sustainable Laboratories, held in June 2021, 

was endorsed and is attached as Annex 3.

6. International Standardisation/Harmonisation

6.1. OIE Register of diagnostic kits

6.1.1. Update on new or renewed applications

The Secretariat for Registration of Diagnostic Kits (OIE SRDK) informed the Commission of 

the current status of the OIE Register of diagnostic kits. At present, there are 14 registered kits. 

There are seven active applications that are being managed by the OIE SRDK:

• Four new applications (submitted in 2019 and 2020) are under evaluation, of which two

are suspended with extended clock stops.

• One application for extension of claim of a registered kit is under evaluation.

• Two new applications for registration of aquatic kits were received in 2021, but are not yet

under evaluation.

The renewal process for one kit (the Rapid MERS-CoV26 Ag Test [BioNote Inc.]) is ongoing. 

The applicant has engaged with the OIE Reference Laboratory for MERS for assistance and 

expects to submit their additional data by the end of 2021 or in January 2022.

6.1.2. Conclusions from the OIE Scientific and Technical Review issue on diagnostic test validation 

science

As reported in agenda item 3.4, the Commission reviewed the conclusions and recommendations 

from the recently published volume of the OIE Scientific and Technical Review on diagnostic 

test validation science. Some of the recommendations concern the OIE Procedure for the 

Registration of Diagnostic Kits. The Commission agreed to discuss these recommendations with 

the SRDK at the next meeting in February 2022. 

6.2. Standardisation programme

6.2.1. AFNOR27: creation of a European Technical committee for diagnostic standardisation

The Commission was briefed on a proposal received from AFNOR for the creation of a 

European Technical Committee (CEN/TC) with the overall objective of creating a European 

standardisation system in the field of animal health through the development of guidelines for 

the implementation of diagnostic methods and quality control of diagnostic reagents, along with 

data management and analytical technologies used for diagnostic methods. The project will 

ensure that it does not duplicate the OIE standards in the Terrestrial and Aquatic Manuals but 

rather complement them. The project, based on available OIE standards, will primarily produce 

recommendations on the implementation of existing methods, but could also address 

complementary issues such as quality control of reagent and dematerialised data exchange. The 

goal of this project is to harmonise European standards and contribute to the animal health 

control chain in collaboration with the OIE and relevant European institutions.

The Commission noted that the intention of this project is not to conflict or duplicate OIE 

standards but to provide complementary information to the diagnostic methodologies in the

Terrestrial Manual and quality control of reagents. The Secretariat along with a Commission 

member will participate in the kick-off meeting of this Technical Committee in September 2021.

26 MERS-CoV: Middle East respiratory syndrome coronavirus

27 AFNOR: Association française de normalisation

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Biological Standards Commission/September 2021 15

7. Follow-up from the General Session

See Agenda Items 3.3 And 9.2.2

8. Conferences, Workshops, Meetings

● Future Conferences, Workshops, Meetings

8.1. ISWAVLD28, Lyon, France, 2023

The 20th ISWAVLD was to be held in Lyon, France in June 2021. Traditionally, the Biological Standards

Commission organises a 1-day seminar held during the Symposium. The OIE is a member of the

Scientific Committee of the ISWAVLD 2021.

Due to the COVID-19 pandemic and travel restrictions and difficulties around visa, air travel and

requirements, the WAVLD Executive board has decided that:

• the typical face-to-face symposium should not be held as a virtual event

• the symposium should be postponed to June 2023 in Lyon, France.

The One Health concept will be a major theme of the symposium, and given the COVID-19 pandemic, 

the spotlight on laboratory diagnosis, and significant work at the OIE related to laboratory sustainability, 

emergency preparedness, and resilience, the theme of the OIE seminar is currently proposed to be “The 

Veterinary Laboratory Function and COVID-19: How can we apply lessons learnt for better preparedness 

and resilience?” Given the postponement of the event, the finalisation of the agenda and list of speakers 

for the OIE seminar will be postponed until February 2022.

9. Liaison with other Commissions

9.1. Horizontal issues among the Specialist Commissions

9.1.1. Review of case definitions

i) Bovine viral diarrhoea

Referring to the description of infection with FMDV29 (see agenda item 9.2.1), the Biological 

Standards Commission recommended that the same principle be applied to the case definition 

for infection with Bovine viral diarrhoea; specifically, that the identity of the virus (option 1) be 

confirmed by the detection of viral antigen or nucleic acid.

The Biological Standards Commission found that the reference to “excluding vaccine strains” 

in option 1 might suggest that the virus has been appropriately identified, and suggested that this 

be made explicit. To this end, the Commission proposed that options 1 and 2 be combined.

The Commission noted the importance of providing recommendations for Members on how to 

identify and thus exclude vaccine strains. The members considered that such details should not 

be included in the case definition itself; rather, this information should be available in the OIE 

Terrestrial Manual.

i) Nipah virus encephalitis

Again referring to the description of infection with FMDV (see agenda item 9.2.1), the 

Commission recommended that the same principle be applied to the case definition for infection 

with Nipah virus; specifically, that the identity of Nipah virus (option 1) be confirmed by the 

detection of viral antigen or nucleic acid.

The Commission questioned the use of serology as stated in option 3. The Commission also

questioned whether the presence of antibodies (with the epidemiological link) would indicate 

28 ISWAVLD: International Symposium of the World Association of Veterinary Laboratory Diagnosticians

29 FMDV: foot and mouth disease virus

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16 Biological Standards Commission/September 2021

active infection with Nipah virus, and proposed revising the text to ensure that option 3 captures 

active infections. The member suggested referring the proposed text back to the expert group to 

ensure that it is appropriate, given the serological tests currently used in animals. In addition, 

the experts may be able to advise whether active infection may be present (or persist) in the 

presence of an antibody response.

In the course of this discussion, Biological Standards Commission noted that the term 

‘seroconversion’ should be defined and included in the glossary of the Terrestrial Manual. The 

following definition was proposed and would be circulated for Member comment (see agenda 

item 3.1). 

• Seroconversion

i) Demonstration of a change from a seronegative to a seropositive condition using a

serological assay specific for the antigen 

OR

ii) Demonstration of a four-fold or more rise in antibody titre between an acute and

convalescent serum using an ordinal test specific for the antigen

The full reports of the development of the case definition for infection with bovine viral diarrhoea viruses 

(bovine viral diarrhoea) and for infection with Nipah virus (Nipah virus encephalitis) can be found at 

annexes xxx and xxx of the September 2021 report of the meeting of the Scientific Commission for 

Animal Diseases. The final versions of the case definitions will be made available on the OIE website.

9.2. Scientific Commission for Animal Diseases

9.2.1. Proposed amendments to the Terrestrial Code and Terrestrial Manual chapters on FMD to 

harmonise the description of infection with FMDV

While reviewing the technical disease card, two FMD experts had noticed a difference in the 

description of infection with FMDV between the Terrestrial Code and Terrestrial Manual. In 

the Terrestrial Code, confirmation of infection with FMDV by virus isolation is considered 

definitive whereas confirmation by other laboratory tests is provisional on other supporting 

evidence. In the Terrestrial Manual, diagnosis of FMD is by virus isolation or by the 

demonstration of FMD viral antigen or nucleic acid in samples of tissue or fluid. 

The experts proposed that the text in the Terrestrial Manual be amended to clarify that it is 

essential to confirm the presence of FMDV by antigen or nucleic acid detection test. The 

Biological Standards Commission fully supported this proposal. Furthermore, the Commission 

proposed that a footnote should be added to Table 1 Test methods available for the diagnosis of 

FMD and their purpose, row “Virus isolation” column “Confirmation of clinical cases”, 

clarifying the need to confirm virus isolation by an antigen or nucleic acid detection test.

Furthermore, the Commission agreed that depending on the agent in question, confirmation of a 

clinical case can involve agent isolation followed by an agent identification test. The 

Commission would review Table 1 of the virus chapters, on a case by case basis, to ensure that 

this point is clarified where appropriate.

The Scientific Commission also agreed with the FMD experts’ proposal. Noting that there is no 

information about virus characterisation in the section of virus isolation of the Terrestrial 

Manual chapter, the Scientific Commission recommended that the experts review that section 

of the chapter too.

The revised chapter is included in the batch of chapters that have been approved to be circulated 

for first-round Member comment (see agenda item 3.1).

The Biological Standards Commission also agreed that the Terrestrial Code Article 8.8.1 needed

to be amended as proposed by the experts to include a requirement to characterise the virus, and 

would advise the Code Commission to consider this comment.

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Biological Standards Commission/September 2021 17

9.2.2.

9.2.3.

Follow-up General Session: emerging recombinant LSDV strains, their correct diagnosis and

notification)

See agenda item 3.3.2. 

Review of assessments of two diseases against the listing criterion 3

The Biological Standards Commission reviewed with the experts assessment of West Nile fever 

and paratuberculosis against listing criterion 3

30 and agreed with their acceptance that both 

diseases fulfil this criterion. 

9.3. Terrestrial Animal Health Standards Commission

Matters discussed between the Terrestrial Animal Health Standards Commission and the Biological 

Standards Commission

9.3.1. Updates from the February 2021 Code Commission meeting

The Biological Standards Commission was updated by the Secretariat on the current topics under 

review by the Code Commission.

10.3.2. Technical questions on Chapter 11.10 Infection with Theileria annulata, T. orientalis and 

T. parva – reply for the Code Commission

The Biological Standards Commission’s advice had been sought on comments from a Member 

regarding point 4) of Article 11.10.5. Recommendations for importation from countries or zones 

not free from infection with Theileria.

The Member questioned the need to subject animals to both serological and agent detection tests 

with negative results on samples taken on entry to the establishment given that the IFAT and 

microscopic examination are both recommended in the Terrestrial Manual for individual animal 

movement. The Biological Standards Commission stressed that the tests are not very sensitive 

and thus both are necessary: the Commission determined therefore that the word “and” is correct 

in the sentence rather than “or”.

Still in point 4) of Article 11.10.5. the Member believed that it is impractical to have testing 

5 days prior to shipment and recommended the same testing schedule that is used in the 

Terrestrial Code chapter on African horse sickness, where testing is conducted at least 25 days 

after entry to the isolation establishment. 

The Biological Standards Commission agreed that 5 days is too short a time to undertake the 

tests and agreed to change it to “at least 25” days. The Commission proposed the following 

amendments to the Article:

4. were subjected to serological and agent detection tests with negative results on samples

taken immediately prior to on entry and five at least 25 days after entry into the isolation

establishment before shipment.

9.4. Aquatic Animal Health Standards Commission

None at this meeting.

10. Matters of Interest for Information

10.1. Update on OFFLU

The Commission was briefed on OFFLU31’s contribution to the WHO Consultation on the Composition 

of Influenza Virus Vaccines on avian influenza and swine influenza for the period September 2020 to 

February 2021. Data for 43 H5 and 13 H9 genetic sequences were contributed by animal health 

30 Criterion 3: Reliable means of detection and diagnosis exist and a precise case definition is available to clearly identify cases 

and allow them to be distinguished from other diseases, infections or infestations

31 OFFLU: Joint OIE-FAO Network of Expertise on Animal Influenza.

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18 Biological Standards Commission/September 2021

laboratories in countries representing Africa, the Americas, Asia, Europe and Oceania to which 150 H5 

and 3 H9 sequences from online resources were also added. Additionally, 504 swine H1 and 174 swine 

H3 global swine influenza A virus sequences from the reporting period were analysed along with 

32 genetic clades of H1 and H3 and antigenic analyses was submitted. These data were used by WHO to 

update the candidate vaccine viruses for production of human vaccines against zoonotic viruses of 

concern. The data collection for the September 2021 WHO meeting is currently underway.

The OFFLU Steering and Executive Committees met virtually in July 2021 to review the progress in the 

work plan of OFFLU technical activities. The Committees received updates from avian, swine, equine, 

wildlife, epidemiology and socioeconomics technical activity leaders and future course of action points 

identified. 

In July 2021, the equine influenza experts participated in the virtual meeting of the OIE expert 

surveillance panel on equine influenza vaccine composition to update the vaccine recommendations for 

the equine industry in 2021.

The OFFLU annual report 2020 was published on the website and disseminated widely.

10.2. Update on rinderpest 

The Commission was informed that the inspections of the laboratories in India and Ethiopia related to 

designation as an FAO-OIE rinderpest holding facility (RHF) and a rinderpest vaccine production 

facility, respectively, are still on hold while awaiting the lifting of COVID-19 related travel restrictions. 

The seven designated RHF, or those for which designation was extended in 2019, would need to be 

reassessed for extension of their designations in 2022, as the term of the RHF’s mandate is 3 years. 

Kazakhstan had destroyed their rinderpest virus containing materials (RVCM) in 2021, leaving only six 

OIE Members holding RVCM. Finally, the Commission was informed that as a result of an open call for 

proposals, the OIE had awarded the Institute for Infectious Animal Diseases, Texas A&M AgriLife 

Research, United States of America, and the Royal Veterinary College, United Kingdom, acting as a 

consortium of OIE Collaborating Centres, the contract for undertaking a risk assessment of rinderpest reintroduction 10 years after its eradication, considering the current distribution of RVCM and emerging 

technologies. This work, which would include a review of progress done in sequestration and destruction 

over the past 10 years, would be ready by the end of the year.

10.3 Update on Global Laboratory Leadership Programme

The GLLP32 Partnership will enable the OIE to provide more comprehensive laboratory systems 

workforce development to Veterinary Services’ stakeholders and to expand access for Veterinary 

Services staff. GLLP will complement existing face-to-face training and provide access to virtual training 

through the OIE’s Training Portal. The aim of the OIE’s involvement in this partnership is to ensure that 

animal health laboratory leaders can benefit from laboratory leadership training, that their context and 

needs are included and addressed, and that they have access to training materials, both through the OIE 

Training Portal and through WHO’s Health Security Learning Platform. 

To support the application of the GLLP’s Laboratory Leaders Competency Framework, the OIE worked 

with its GLLP partners to finalise the first version of the GLLP Learning Package materials (three 

Sections: Laboratory Management; Laboratory Leadership; and Laboratory Systems; nine units and 

42 modules). All materials have been adapted to have a strong One Health focus, although environmental 

health expertise is still needed. This version is currently available for GLLP partners’ access only on the 

WHO Health Security Learning Platform for piloting and testing. Materials include instructor’s guides, 

participant’s guides, slide decks, programme implementation guide and mentoring guide in both face-toface and virtual learning formats, targeted at health laboratory system management and leadership. 

Next steps include incorporating additional modifications from testing and piloting experience in order 

to publish open-source versions of all GLLP Learning materials by mid-2022.

32 GLLP: the Global Laboratory Leadership Programme

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Biological Standards Commission/September 2021 19

10.4. The potential role for BCG vaccination in global efforts to control and eradicate bovine 

tuberculosis

The OIE Reference Laboratory for bovine tuberculosis in the United Kingdom had submitted a technical 

discussion paper on the potential role for BCG33 vaccination in global efforts to control and eradicate 

bovine tuberculosis. The Reference Laboratory is developing a new approach to the control of bovine 

tuberculosis based on vaccination by subcutaneous injection of BCG and complementary use of an 

associated DIVA skin test to identify infected animals within a vaccinated population instead of the 

conventional tuberculin skin test. The approach is aimed at replacing the current control method of testing 

and slaughtering infected animals.

The Commission agreed that the BCG vaccination and DIVA skin test approach looks very promising

and could provide an alternative to bovine tuberculosis control that could be used in certain countries in 

certain situations. The Commission felt however, that it is premature to include it in the Terrestrial 

Manual at present. The Commission encourages the Reference Laboratory to continue with the validation 

of the DIVA approach and would welcome regular progress reports. Before considering its inclusion, the 

Commission would expect to receive strong evidence that this new methodology and control strategy is 

appropriate and safe and has been fully validated to the OIE standard (see also agenda item 3.1).

The Commission is aware that the inclusion of this approach in the Terrestrial Manual will have an 

impact on the Terrestrial Code in particular how the Code defines freedom from tuberculosis for trade 

purposes – currently defined by measuring reaction to tuberculin. The DIVA approach would be a 

complete shift in the current tuberculosis control strategy that would need to be clearly explained and 

presented to the Members, many of which do not currently allow vaccination. The Reference 

Laboratory’s validation data will also assist the OIE to better present this new approach to Members.

10.5. Update on COVID-19

The Commission was updated on the activities of the OIE in response to COVID-19. The OIE remains 

mobilised and is working with its network of experts and partners, including WHO and FAO, to support 

its Members in responding to this One Health crisis by taking a multi-sectoral approach. With the support 

of the ad hoc Group on COVID-19 and the human–animal interface, the OIE is regularly assessing the 

reports of both natural and experimental infection in animals to inform the development of risk-based 

guidance and to adapt risk communication messages. The OIE regularly updates its Questions and 

Answers Page on the COVID-19 portal, as well as the list of events reported by OIE Members of natural 

infection of animals with SARS-CoV-2 and the OIE Technical Factsheet on Infection of animals with 

SARS-CoV-2. The joint OIE and FAO advisory group on viral evolution of SARS-CoV-2 in animals 

continues to inform and advise the organisations on the on risks related to the evolution of SARS-CoV2 (through mutation or recombination) in animal populations.

10.6. Update on Global Burden of Animal Diseases programme

The objective of GBADs34 is to assess the economic burden of animal diseases in standardised terms of 

production loss, expenditure, and trade impacts. The accumulated data and analytical output will support 

evidence-based decision-making on investments in the livestock and aquatic animal sectors by various 

actors such as policy makers, the private sector, and donors. GBADs is currently developing 

methodologies and a prototype analytics platform. The GBADs methodology development will focus on 

populations, biomass and value of livestock and aquatic animals, on animal health ontologies, and on 

animal health loss envelope. A peer review of the programme’s methodology following OIE processes is 

planned for the second half of 2022. The newly designated OIE Collaborating Centre for the Economics 

of Animal Health will operate in the European region while also supporting the development of similar 

consortia in other regions notably in Africa and the Asia-Pacific linking with GBADs case study 

implementation partners in Ethiopia and Indonesia, respectively.

33 BCG: Bacille Calmette-Guérin

34 GBADs: Global Burden of Animal Diseases programme

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20 Biological Standards Commission/September 2021

11. Any Other Business

11.1. Work plan

The updated work plan was agreed and can be found at Annex 4.

11.2. Dates of the next Biological Standards Commission meeting

The Commission noted the dates for its next meeting: 7–11 February 2022.

_______________

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.../Annexes
Biological Standards Commission/September 2021 21

Annex 1

MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Virtual meeting, 6–10 September 2021

__________

Agenda

1. Welcome and Commission Induction

2. Adoption of Agenda

3. Manual of Diagnostic Tests and Vaccines for Terrestrial Animals

3.1.

3.2.

3.3.

Review of draft chapters received and their endorsement for circulation for first-round Member 

comment Follow-up from pre-General Session webinars 

Follow-up from the General Session 

3.31. Chapter 3.5.8 Equine piroplasmosis

3.3.2. Chapter 3.4.12 Lumpy skin disease

3.4. Conclusions and recommendations from the OIE Scientific and Technical Review issue on diagnostic test 

validation science 

3.5. Review of a validation dossier for a quantitative real-time PCR method for detection of Taylorella equigenitalis

directly from swabs, and proposed text for Chapter 3.6.2 Contagious equine metritis

3.6. Request to update Chapter 3.6.11 Glanders and melioidosis to include a new recombinant antigen-based ELISA

3.7. Request to update Chapter 3.1.1 Anthrax to include a new easier to produce Bacillus anthracis capsule stain

3.8. Including OIE Terrestrial Manual chapters in national regulations: requirement to mention the most recently 

adopted version of the OIE Standard

3.9. Review of Terrestrial Manual status: selection of chapters for update in 2022/2023 review cycle

4. OIE Reference Centres

4.1. Applications for OIE Reference Centre status

4.2. Changes of experts at OIE Reference Centres

4.3. Review of new and pending applications for laboratory twinning

4.4. Inconsistencies among OIE Reference Laboratories in results obtained using the real-time RT-PCR for African 

horse sickness 

Reference Laboratories – Implementation of the SOPs 

4.5. Follow-up February meeting: further feedback from the Laboratories that are not complying with the key ToR 

according to their 2018 annual report

4.6. Feedback from the Laboratories that are not complying with the key ToR according to 2019 annual report

4.7. In-depth review of all annual reports for activities in 2020

Collaborating Centres – Implementation of the SOPs

4.8. Follow-up February meeting: feedback on the mapping exercise for the existing Centres against the list of main 

focus area and specialties 

4.9. Follow-up February meeting: feedback from the Centres that are not complying with the key ToR according to 2019 

annual report

4.10. Follow-up September: feedback on the review of the 5-year work plans received from Collaborating Centres

4.11. In-depth review of all annual reports for activities in 2020

Reference Centre networks

4.12. Update on the three Reference Laboratory networks (rabies, PPR and ASF) 

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Annex 1 (contd)

22 Biological Standards Commission/September 2021

5. Ad hoc Groups

Update on activities of past ad hoc Groups

5.1. Ad hoc Group on Replacement of the International Standard Bovine Tuberculin (ISBT): update on the replacement 

ISBT

5.2. Ad hoc Group on the revision of Terrestrial Code chapters regarding the collection and processing of semen of 

animals, 9 November 2020 to 15 January 2021

5.3. Ad hoc Group on Sustainable Laboratories 

6. International Standardisation/Harmonisation

6.1. OIE Register of diagnostic kits: 

6.1.1. Update and review of new or renewed applications

6.1.2. Conclusions from the OIE Scientific and Technical Review issue on diagnostic test validation science

6.2. Standardisation programme 

6.2.1. AFNOR: creation of a European Technical committee for diagnostic standardisation

7. Follow-up from the General Session

8. Conferences, Workshops, Meetings

Future Conferences, Workshops, Meetings

8.1. ISWAVLD, Lyon, France, 2023

9. Liaison with other Commissions

9.1. Horizontal issues among the Specialist Commissions 

9.1.1. Review of case definitions

9.2. Scientific Commission for Animal Diseases

9.2.1. Proposed amendments to the Code and Manual chapters on FMD to harmonise the description of infection 

with FMD virus

9.2.2. Follow-up General Session: emerging recombinant LSDV strains, their correct diagnosis and notification

9.2.3. Review of assessments of two diseases against the listing criterion 3 

9.3. Terrestrial Animal Health Standards Commission

9.3.1. Updates from the February 2021 Code Commission meeting

9.3.2. Technical questions on Chapter 11.10 Infection with Theileria annulata, T. orientalis and T. parva – reply 

for the Code Commission

9.4. Aquatic Animal Health Standards Commission

9.4.1. Nothing for this meeting

10. Matters of Interest for consideration or information

10.1. Update on OFFLU

10.2. Update on rinderpest 

10.3 Update on Global Laboratory Leadership Programme

10.4. The potential role for BCG vaccination in global efforts to control and eradicate bovine tuberculosis

10.5. Update on COVID-19

10.6. Update on Global Burden of Animal Diseases programme

11. Any other business

11.1. Workplan

11.2. Dates of the next Biological Standards Commission meeting: 7–11 February 2022

12. Meeting review

______________

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Biological Standards Commission/September 2021 23

Annex 2

MEETING OF THE OIE BIOLOGICAL STANDARDS COMMISSION

Virtual meeting, 6–10 September 2021

__________

List of participants

MEMBERS

Prof. Emmanuel Couacy-Hymann

(President)

Professor of Virology, Central 

Laboratory for Animal Diseases 

(LANADA/CLAD)

BP 206 Bingerville

CÔTE D’IVOIRE

chymann@gmail.com

Dr Joseph S. O’Keefe

(Member)

Head, Animal Health Laboratory

Ministry for Primary Industries

P.O. Box 40-742

Upper Hutt, 5140

NEW ZEALAND

Joseph.O’Keefe@mpi.govt.nz

okeefej@mpi.govt.nz

Prof. Ann Cullinane

(Vice-President)

Head of the Virology Unit

Irish Equine Centre

Johnstown, Naas

Co. Kildare

IRELAND

ACullinane@irishequinecentre.ie

Dr Satoko Kawaji

(Member)

Principal Scientist

Division of Infectious Animal Disease 

Research, National Institute of Animal 

Health, Naro

JAPAN

skawaji@affrc.go.jp

Dr John Pasick

(Vice-President)

Formerly Canadian Food Inspection 

Agency, National Centre for Foreign 

Animal Disease, 1015 Arlington Street

Winnipeg, Manitoba R3E 3M4

CANADA

jmpasic55@gmail.com

Dr Chris Oura

(Member)

Professor of Veterinary Virology

Faculty of Medical Sciences

The University of the West Indies

TRINIDAD AND TOBAGO

chris.oura@sta.uwi.edu

CONSULTANT EDITOR OF THE TERRESTRIAL MANUAL

Dr Steven Edwards

c/o OIE 12 rue de Prony

75017 Paris

FRANCE

steve@cabanas.waitrose.com

OIE HEADQUARTERS

Dr Gregorio Torres

Head, OIE Science Department

g.torres@oie.int

Ms Sara Linnane

Scientific Officer – International 

Standards,

OIE Science Department

s.linnane@oie.int

Dr Gounalan Pavade 

Scientific Coordinator, OIE Science 

Department

g.pavade@oie.int

_______________

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24 Biological Standards Commission/September 2021

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Biological Standards Commission/September 2021 25

Annex 3

Original: English

June 2021

MEETING OF THE OIE AD HOC GROUP ON SUSTAINABLE LABORATORIES

1-4 June 2021

_______

The OIE ad hoc Group on Sustainable Laboratories met for its third meeting 1-4 June 2021. Due to COVID-19, 

the Group was not able to meet face-to-face. Given the Group’s membership and distribution across time zones, 

zoom meetings were held over four days to cover the agenda items and achieve the meeting’s objectives.

Additional zoom meetings will be convened on an ad hoc basis to further develop the action items of the meeting.

Welcome and Meeting Objectives

Ms Jennifer Lasley, OIE Sustainable Laboratories Programme Manager of the Preparedness and Resilience 

Department, welcomed the participants and underlined the importance of taking stock of the work done to date in 

three key areas—economic indicators for laboratory sustainability, mission methodology, and data—to consider 

proposed next steps for each area of work and agree on path forward, and to address specific objectives for each 

thematic session. 

Dr Ana Maria Nicola resumed as Chairperson. Mrs Barbara Martin and Mr David Korcal, along with OIE staff, 

acted as rapporteurs. The adopted Agenda and List of Participants are presented in Annexes I and II of this report, 

respectively.

Economic Indicators of Sustainable Laboratories

Dr Nick Lyons presented an update on behalf of the Economics team1 on the development of the economic 

indicators for laboratory sustainability. An Expert Opinion Elicitation (EOE) exercise was conducted with 

laboratory management experts to assess the importance and feasibility of proposed key performance indicators 

(KPI) for economic sustainability of a laboratory system network. The aims of the indicators are to capture 

information needed by managers to improve decision making, in a way that is easily understandable, and is based 

on economic sustainability-related outcomes for effective laboratory services.

Figure 1: Economic Sustainability cycle framework for laboratory systems.

1 Composed of J Rushton and N Lyons of University of Liverpool, and Jessica Cargill, Miguel Gonzales, and Terry 

McElwain of Institute for Infectious Animal Diseases (IIAD), OIE Collaborating Centre for Biological Threat Reduction. 

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26 Biological Standards Commission/September 2021

Dr Lyons reviewed the methodology of the EOE, in which the Group participated. The participating experts 

categorised each indicator’s importance and feasibility as Low, Medium, or High (with an option for no opinion).

The exercise was completed by 38 respondents from 28 countries. The methods, results, and conclusions to 

recommend a list of economic indicators for laboratory sustainability will be detailed in their final report (due in 

fourth quarter 2021), at which point the Group will make contributions.

Dr Lyons also presented outputs under consideration: benchmarks, as reference points that could be used by 

Members to see how their performance compares with peers, and the development of levels (similar to the PVS 

Tool) in thematic areas—financial, services, and resources—to evaluate and identify areas in the laboratory 

network where economic sustainability may be compromised and can facilitate priority and target determination.

Regarding benchmarks, Dr Lyons explained the importance of putting the tool and its outputs into context and 

considering geography, the importance of livestock sector, and the economic status of the country. The Group 

suggested a heat map or traffic light system visualisation of tool outputs instead of prescriptive targets, since this 

type of format will present the risks to laboratory sustainability in certain areas and for specific indicators. 

The Group thanked the experts for their work and reiterated that the aim of the economic indicators for laboratory 

sustainability is to develop an open-source tool for Members to understand areas where resource sustainability can 

be improved in the laboratory system. The tool is being developed to be used in conjunction with the PVS 

Sustainable Laboratories mission and tools, before or after a planned mission, or as a first look at laboratory 

sustainability in the laboratory system, prior to a request for a PVS Sustainable Laboratories Mission. 

The Group participated in an exercise to assess the availability and accuracy of data for each indicator within their 

own laboratory networks, and if they should be included in a “sustainability index”, followed by a pairwise ranking 

of the indicators. The results of the Group’s work will inform the final revisions of the proposed indicators, 

modelling, and testing. Some refinements of the KPI definitions are needed. Dr Lyons reported that preliminary 

results of the exercise reflect that “Service” KPIs are easily available and are of the highest quality, followed by 

the “Resource” KPIs, with the most uncertainty over “Financial” KPIs. At this stage, all KPIs could be included 

in a sustainability assessment subject to proposed changes by the Group.

The Group developed a working definition for economic sustainability of laboratory systems as “sufficient 

resources (public and/or private) for the provision of accurate and timely data, information, and laboratory services 

that continually responds to the demand of the laboratory network’s respective animal and public health sectors”

to assist continued work in this area and to complement the working definition developed by the Group of 

“sustainable laboratory system”

2. The Group agreed that this definition is necessary for next steps, notably for 

advocacy development and the writing of the position paper on investment needs for sustainable laboratories.

Dr Lyons informed the Group on additional outputs of their work. Given the different types of economic analyses

that could bring benefit to a laboratory system, the economic experts indicated that a full cost-benefit analysis 

(CBA) or cost-effectiveness analysis (CEA) can take several months to complete and therefore a “one-size fits all” 

tool is not well adapted to complement the PVS Sustainable Laboratories mission or tools approach at this time.

They stated that the PVS Sustainable Laboratories support and the Economic Indicators for laboratory 

sustainability efforts towards appropriate data collection and analysis will provide needed good practices for 

countries towards conducting CBA and CEA, an excellent contribution towards sector-wide efforts like Global 

Burden of Animal Diseases (GBADs) to understand the benefits of Veterinary Services and its contributions to 

preparedness and prevention. The experts will produce guidance on how to do a cost-benefit analysis focussing on 

investments in biosafety and biosecurity, with considerations for how inputs/outputs of PVS Sustainable 

Laboratories tools can be leveraged for CBA and CEA, by including examples using data from previous missions.

The Group supported this proposal and looks forward to the outcomes of this work.

Ms Cargill presented a proposed outline for the position paper on advocating for sustainable laboratories. Proposed 

topics to be discussed in the paper are:

• introduction on role of laboratories in surveillance systems, emergency management systems, and 

research and balance between public and private funding, national and external investment;

2 A system/network of laboratories that can maintain appropriate safety, security, and quality on a path towards compliance 

with OIE International Standards, taking into account social, environmental, and economic factors in its day-to-day 

operations for the benefit of the health system

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OIE ad hoc Group on Sustainable Laboratories / June 2021 Annex 3 (contd)

Biological Standards Commission/September 2021 27

• defining “economic sustainability for laboratory systems”, demonstrating economic sustainability as 

critical in securing investments into laboratory systems, the ability of laboratory systems to advocate for 

themselves, benefit streams, and the ability to provide timely, accurate, safe, and secure diagnosis;

• overview of the PVS Sustainable Laboratories missions, tools, and discussion of gaps in some economic 

indicators;

• working towards an economic basis for sustainability through description of economic dynamics for 

veterinary laboratory systems so that Members understand economics as well as scientific and 

management components of their work, CBA (and when it is needed and appropriate), and the need for 

other economic tools to understand sustainability;

• development of a Sustainability Index with KPIs, based on EOE and benchmarking exercises and testing;

• case studies from 1-3 countries in the cohort tested against the KPIs;

• future directions and recommendations.

The Group agreed for continued development in this direction and that multiple publications in different formats 

for advocacy tools, like policy briefs, peer-reviewed articles, and a white paper would be helpful to address the 

topics proposed and to reach different audiences. The Group brainstormed different options for presenting the 

work to the public, like an OIE Scientific and Technical Review special issue on laboratory sustainability, a special 

session during the OIE Seminar or in general session of WAVLD on economic sustainability. Members of the 

Group were invited to contribute to the documents as authors. The Group proposed that revisions integrating 

sustainability into existing standards in the Terrestrial Manual could be proposed, potentially with a new chapter 

on considerations for economic sustainability of laboratory systems. The Group noted that this work will contribute 

to the transformative agenda proposed for laboratory strengthening by the OIE Preparedness and Resilience 

Department and following the Resolution 313 and its Technical Item “Lessons Identified From Before And During 

The Pandemic: How The OIE Can Support Veterinary Services To Achieve One Health Resilience” and towards 

the OIE 7

th Strategic Plan.

The Group also made additional comments to be taken into account the next steps:

• Gender and age are important factors in relation to access to training and are important to sustainability 

and succession planning.

• Relative contribution indicator should be retained.

• AMR studies with the World Bank and useful models for this can be leveraged.

• OECD linkages with OIE can be leveraged on this work.

• Binding commitments at highest governmental and multilateral organisations should be sought in 

recovery and preparedness phases.

Mission Methodology 

At its last meeting, the Group considered “virtual” PVS Sustainable Laboratories mission delivery and 

recommended piloting the approach and adapting the mission methodology to a virtual delivery. Since that time, 

the OIE decided to undertake a pilot remote PVS Sustainable Laboratories mission and proposed to Liberia, whose 

mission had been cancelled due to COVID-19 in March 2020. Liberia accepted to participate in this pilot in late 

2020 and the mission occurred 22 March to 9 April 2021. Dr Ana Maria Nicola, Mr David Korcal, and Ms Barbara 

Martin served as the Expert team in conjunction with OIE Observers Ms Jennifer Lasley, Dr Valentyna Sharandak

and Mr Emmanuel Appiah. The Liberia Expert team presented their experience by mission phase, the lessons 

learned, and major innovations made. The advantages and disadvantages of a 100% remote mission delivery and 

recommendations were also presented.

The major innovations were presented to the Group:

• Developed the 1st full 100% remote mission approach;

• Developed and tested the data collection Phase 1;

• Developed and tested Phase 2 web-based approach, based on the previous Mission format;

• Developed Satisfaction Survey for mission participation by the country team;

• Developed and tested the New Data Entry Tool (Supply Tool replacement);

• Developed and provided videos to provide instruction on tool use;

• Utilized improved tool functionality to produce data visualisations for faster insight and feedback in Phase 

1 and Phase 2;

3 Presented and adopted at GS88.

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Annex 3 (contd) OIE ad hoc Group on Sustainable Laboratories / June 2021

28 Biological Standards Commission/September 2021

• Provided clearer definition of the roles of country focal point;

• Conducted risk analysis for 100% remote mission delivery;

• Developed Mission supporting documents in early stages to increase understanding;

• Documented areas for improvement and additional work to be done for next missions;

• Developed templates for each meeting and stage to ensure more structure and quality control;

• Developed a Donor Questionnaire to be filled in by the OIE Delegate and Lab management to obtain 

relevant information about budget;

• Tested the report outline developed by AHG.

Figure 2: 100% Remote PVS Sustainable Laboratories mission: Liberia experience

The Liberia Expert team presented the results of the testing of the newly developed Satisfaction Survey (Microsoft

Forms) for PVS Sustainable Laboratories Mission participants. Six participants in the mission (out of 9) filled in 

the survey. In general, the respondents agreed that the data entry tool was easy to use and navigate, the instructions 

were easy to understand, and that the data can be used to monitor their laboratory’s level and performance over 

time. The amount of time required to fill in the tool still requires some effort in the respondent’s opinion, but 

automatic visualisations and dynamic dashboards are under development to add more value to this data collection 

phase and produce an additional output to complement the Mission Report for any PVS Sustainable Laboratories 

mission. The participants rated the overall success of the mission at 8.2 out of 10. The survey and results were 

reviewed, The Group suggested standardization of the response options for improved understanding and reporting 

of results.

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OIE ad hoc Group on Sustainable Laboratories / June 2021 Annex 3 (contd)

Biological Standards Commission/September 2021 29

Areas of improvement to be addressed in the next pilot missions include:

• Better define the Delegate’s role in mission:

o Develop Agenda for 1st webinar with Delegate & Country Contact Person.

o Determine which data & documentation should be provided by Delegate (as opposed to Lab staff).

o Request budget information from Delegate and donors.

o Explain the need for baseline documentation and how to obtain it.

o Standardise requests and timing for Delegate.

o Determine with the Delegate which laboratories must participate.

• Address through methodology how to incorporate larger lab network;

• Further innovate and integrate Data Entry Tool and Integrated Demand/Calculation Tool;

• Continue work on compiling data from multiple laboratories in a network and migrating data to database;

• Continue work to streamline the data entry process and develop additional multimedia materials to 

support those providing information;

• Address access to information of the lab leadership by engaging the Delegate more and creating 

connections between the national laboratory and VS;

• Provide additional explanation of the importance of information requested;

• Develop “pre” Phase 1 webinars or training videos to explain purpose to Member Country;

• Provide more exposure to the virtual mission format prior to the actual mission along with opportunities 

for discussions to increase understanding and assist with the mission process. The webinars and training 

should be available in OIE languages and include the following:

o Description and instruction of the tool.

o Baseline documents video.

o Mission overview.

During the next AHG meeting, the similarities and differences between face-to-face and remote pilot missions will 

be used to highlight the new advancements.

The Expert team reported that the revised report outline developed by the Group succeeded in reducing the report 

to a more accessible format and keep the detail in the appendices of the report.

The Group agreed that the next months should be spent to better develop the communication materials as additional

remote missions occur. The time between remote missions should be used to advance on materials for the different 

Mission phases. Another option to consider is to provide mission related training to the OIE laboratory focal points

at the next opportunity in the calendar.

The Group agreed that the effort to convert the face-to-face mission format to a 100% remote delivery was 

excellent and the experience was overall a positive one, given the challenges experienced. The current COVID-19 

pandemic has illustrated even more the need for such an approach. The Group was encouraged by the high quality 

of the first pilot mission materials developed and encouraged experts that each mission will improve progressively.

The Group congratulated the Experts for making the process more documented, standardized, and streamlined for 

future experts to implement, and was recognised as a step forward. 

The Group recommended that a virtual delivery component in the data collection Phase 1 (through 

webinars) could be used in the future, even when face-to-face missions are possible again. The Expert 

teams suggested that once international travel is possible again, a blended model with involvement of 

regional experts should be considered where Phase 1 occurs remotely, and the remainder of the Mission 

occurs face-to-face.

The Group agreed that it is fruitful to explore further connections and synergies between the OIE 

Twinning Programme and projects and PVS Sustainable Laboratories missions and how they can inform 

one another better and contribute to each other’s outcomes. For example, sharing the report would be a 

great way to improve the connections.

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30 Biological Standards Commission/September 2021

Data Collection and Visualisation

At its last meeting, the Group considered testing transferring the PVS Sustainable Laboratories mission data entry, 

calculations, visualisations, and tools to an online platform, and Mr Appiah, Ms Lasley, and Mr Korcal presented 

the accomplishments to date and gave indications on the direction of future development towards this goal.

Mr. Korcal provided a demonstration of the Data Entry Tool (DET) and explained that the offline tool is still in 

MS Excel format since widely accessible. The Group’s recommendations from the first and second meetings on 

data collection and management were implemented and integrated into a beta version which was demonstrated to 

the Group. The DET is markedly different as there has been much integration and improvement. The DET uses 

macros and has been tested for functionality on Macs and PCs. A dashboard lists all the data categories and 

provides navigation buttons and user forms for data entry. Instructions are available as well as summarized in a 

printable format. The process for securely uploading data to OIE SQL database has been developed and includes 

saving data as CSV and then exporting aggregated data to the OIE SQL database. The process can be used for 

either individual laboratories or a network of laboratories. Data from the Liberia virtual mission were used to 

demonstrate the data visualizations that were generated as data were entered. Next steps in tool refinement and 

development include a streamlined dashboard and the ability to navigate to separate dashboards (personnel, 

demand for services).

Figure 3: Example of a visualization from the DET, on test demand by disease 

Mr. Appiah and Ms. Lasley provided an overview of the country dashboard mock-up (Figure 4). An overview of 

the IT high-level plan for online web portal development was provided with accomplishments to date. Phase 1 

(data structure management) was completed December 2020 and included database structure development, data 

aggregation, data cleaning, database scripting, and data migration. Phase 2 (Data insights and dashboard) is 

currently underway and is scheduled to be completed July 2021. The PVS Lab dataset is from 16 member countries 

(2012-2019) with 168 laboratories and more than 193,000 pieces of data. The Equipment survey dataset includes

data from 136 Member Countries with 223 laboratories providing information on over 68k+ pieces of equipment.

Calculations are used in the background to visualize the cohort data in a dashboard format.

4; 0%

108; 1%

9; 0%

108; 1%

50; 0%

7920; 45%

9360; 53%

279; 2%

Number of Tests by Disease Anthrax

Brucella abortus, Brucella melitensis and

Brucella suis (Inf. with)

General parasitology

Mycobacterium tuberculosis complex (Inf.

with)

Peste des petits ruminants virus (Inf. with)

Rabies virus (Inf. with)

Avian influenza viruses (Inf. with)

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OIE ad hoc Group on Sustainable Laboratories / June 2021 Annex 3 (contd)

Biological Standards Commission/September 2021 31

Figure 4: Country mock-up dashboard for PVS Sustainable Laboratories mission (all data is made for demonstration purposes 

only and once finalised, will be translated into Spanish and French)

Phase 3 (Portal and e-forms), scheduled to begin in 4

th quarter 2021 and continue through 2023. The goal of Phase 

3 is real-time data visualization and analysis and will involve going from offline MS Excel tools to a secure, online,

integrated web portal with outputs that can be seen by different audiences (MC, PVS experts) with different levels 

of access. A country view dashboard mock-up was demonstrated (Figure 4). Buttons for separate dashboards for 

economic, laboratory management, and PVS Sustainable Laboratories Mission were presented with many 

functionalities and presentations possible according to the indicators that the AHG will decide over the coming 

months. Data will be able to be viewed by network (country), but there could also be an option to view by 

individual laboratory, which makes it an appealing tool for Delegates, Focal Points, and Laboratory Leaders to use 

as a management tool at the laboratory and network levels. Benchmarks and AHG input will be used to finalize 

mock-ups for different uses, and once consultations with Members occur, translation of content into Spanish and 

French will be possible. Following the presentation and demonstration, the Group discussed next steps and made 

detailed recommendations for immediate implementation.

Additional considerations for next steps

The recommendations from the Group’s first and second meetings determined the goals for continued work of the 

Group. The Group’s input has been implemented throughout the remote mission approach, analysis of data and 

leveraging the data provided, the beta version of the Data Entry Tool, while also taking into account feedback from 

Experts who had used the tools in the past and data integrity best practices. Ms Lasley reiterated the achievements 

made since the last meeting of the Group to take stock of the Group’s outputs and achievements to date.

The Group agreed that much progress had been made and agreed that the following need to be considered as the 

project progresses:

• Determine how to demonstrate economic sustainability at the country level and how it impacts the 

laboratory network;

• Follow up missions and impact evaluations can occur in parallel, to measure impact for all missions, not 

just those that request PVS Lab or other follow-up missions;

• The Web portal will also allow the follow up over time according to the Members interest in using the 

portal as a management information system;

• Follow Up missions can occur in virtual format;

• Prepare a survey for countries to determine progress;

• Determine how to encourage regional sharing and analysis to better understand transboundary challenges;

• Consider adding other fields of expertise to the Mission Expert team such as economists and

epidemiologists;

• Form a subgroup to determine priorities for multimedia tool (video) development;

• A subgroup was formed to work on Country mission manual outline development;

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32 Biological Standards Commission/September 2021

• Develop a communication plan to inform stakeholders of progress and ensure impact on policy makers 

regarding guidance on investment in laboratory systems;

• Tools and documentation are not yet finalized and may impact activities;

• Develop pre-mission action plans that can be used as a template for future missions;

The Group expressed their satisfaction with the improvements presented at the meeting and congratulations were 

extended to those working on the project day to day.

The next meeting of the ad hoc Group is targeted to be held in mid-2022, date to be determined. Ad hoc meetings 

will be scheduled with subsets of the committee to advance on particular tasks.

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OIE ad hoc Group on Sustainable Laboratories / June 2021 Annex 3 (contd)

OIE ad hoc Group on Sustainable Laboratories / June 2021 33

Appendix I

MEETING OF THE OIE AD HOC GROUP ON SUSTAINABLE LABORATORIES

Paris, 1–4 June 2021

_____

List of Participants

MEMBERS

Dr Ana Maria Nicola (Chair) 

Directora General de Laboratorios y Control 

Técnico 

SENASA

Talcahuano 1660

(CP 1640), Martinez

Buenos Aires 

ARGENTINA

Dr Gemma Clark 

CSIRO Australian Centre for Disease Preparedness

PMB 24 Geelong 3220

AUSTRALIA

gemma.clark@csiro.au

Dr Alfonso Clavijo (regrets)

Director

National Bio and Agro-Defense Facility (NBAF)

USDA, Agricultural Research Service

1880 Kimball Ave, Suite 300

Manhattan, KS 66502

alfonso.clavijo@usda.gov

Dr André de Oliveira Mendonça 

Coordenador Substituto

Laboratório Federal de Defesa Agropecuária

Ministério da Agricultura, Pecuária e 

Abastecimento

Rua Raul Ferrari S/n, Jardim Santa Marcelina, 

Campinas-SP,

BRAZIL

andre.mendonca@agricultura.gov.br

Dr Salama Al Muhairi

Director of Veterinary Laboratories Division

Animal Wealth Sector

Abu Dhabi Agriculture and Food Safety Authority

52150, AD

UNITED ARAB EMIRATES

Salama.almuhairi@adafsa.gov.ae

Dr Nick Nwankpa

Director

Pan African Veterinary Vaccine Center - African 

Union Commission

P. O. Box 1746,

Debre Zeit

ETHIOPIA

NickN@Africa-union.org

Dr Heather Sheeley

Independent Expert

UNITED KINGDOM

hsheeley@hotmail.com

OBSERVERS

Dr Lisa Stevens

Laboratory Strengthening & Surveillance

WHO Lyon Office 

Immeuble Tony Garnier

24 rue Jean Baldassini

69007 Lyon

FRANCE

stevensl@who.int

Ms Beatrice Mouillé

EMPRES Laboratory Unit Deputy 

Coordinator

Animal Health Services (AGAH) 

Emergency Centre for Transboundary 

Animal Diseases (ECTAD) 

Viale delle Terme di Caracalla 

00153 Rome

ITALY 

Beatrice.Mouille@fao.org

CONSULTANTS

Mrs Barbara Martin

Executive Director

WAVLD

2503 Eisenhower Ave Iowa 50010

UNITED STATES OF AMERICA

Martin.barbara.m@gmail.com

Mr David Korcal

376 Green Street

Perry, Michigan 48872

UNITED STATES OF AMERICA

korcal61@gmail.com

Prof Jonathan Rushton 

Director of the Global Burden of Animal 

Diseases Programme 

Institute of Infection, Veterinary and 

Ecological Sciences

University of Liverpool

IC2 Building, 146 Brownlow Hill, Liverpool 

L3 5RF

UNITED KINGDOM

jrushton@liverpool.ac.uk

Dr Nick Lyons

Honorary Research Fellow

Institute of Infection, Veterinary and 

Ecological Sciences

University of Liverpool

UNITED KINGDOM

nlyons@liverpool.ac.uk

Ms Jessica Cargill

Institute for Infectious Animal Diseases 

(IIAD)

Texas A&M AgriLife Research

578 John Kimbrough Boulevard, Suite 201

College Station, TX 77843-2129

USA

Jessica.Cargill@ag.tamu.edu

Prof Terry McElwain (regrets)

Regents Professor Emeritus

Paul G. Allen School for Global Animal 

Health

College of Veterinary Medicine

101 Allen Center, PO Box 647090

Washington State University

Pullman, WA 99164-7090

UNITED STATES OF AMERICA

terrymcelwain@gmail.com

Mr Miguel Gonzales

Institute for Infectious Animal Diseases 

(IIAD) 

Texas A&M AgriLife Research

578 John Kimbrough Boulevard, Suite 201

College Station, TX 77843-2129

USA

Miguel.Gonzalez@ag.tamu.edu

OIE STAFF

Ms Jennifer Lasley

Preparedness and Resilience Department

12 rue de Prony

75017 Paris

FRANCE

j.lasley@oie.int

Mr Emmanuel Appiah

Digital Transformation and Information 

Systems Department

12 rue de Prony

75017 Paris

FRANCE

e.appiah@oie.int

Dr Valentyna Sharandak

Capacity Building Department

12 rue de Prony

75017 Paris

FRANCE

v.sharandak@oie.int

UNOFFICIAL VERSION
Annex 3 (contd) OIE ad hoc Group on Sustainable Laboratories / June 2021

34 Biological Standards Commission/September 2021

Appendix II

MEETING OF THE OIE AD HOC GROUP ON SUSTAINABLE LABORTORIES

1-4 June 2021

PROPOSED AGENDA

Day 1 (June 1): Economics Team outputs

• Objectives: 

o To share progress on EOE and to finalise the list of indicators

o To demonstrate models developed to date

o To discuss next steps proposed and the Group’s perspectives

o To examine impact of integration of new variables into Data Entry Tool

• Presentation on KPI development and results of EOE (30 minutes) 

• Exercise on KPIs (30 minutes) 

• Feedback from groups on KPI exercise (30 minutes) 

• Presentation on the proposed advocacy paper (with discussion) 

Day 2 (June 2): Liberia pilot mission outcomes

• Objectives:

o To present the major innovations in mission methodology including remote delivery 

o To take stock of the work done to date

o To discuss next steps proposed and the Group’s perspectives

• Major innovations in mission methodology 

• Recommendations in preparation for next mission and the future

• Discussion 

Day 3 (June 3): Data Entry Tool and data visualisation development

• Objectives:

o To demonstrate the Data Entry Tool and its major innovations

o To demonstrate a country dashboard (mockup) and preliminary dashboards on the cohort analysis

o To discuss next steps proposed and the Group’s perspectives

• Data Entry Tool 

• Power BI Dashboards 

• Discussion 

Day 4 (June 4): Conclusions

• Conclude any remaining agenda items

• Project changes 

• Taking Stock: Accomplishments to date 

• Next steps 

• Discussion 

• Closing

UNOFFICIAL VERSION
Biological Standards Commission/September 2021 35

Annex 4

Work Programme for the OIE Biological Standards Commission

Subject Issue Status and Action

Updating the 

Terrestrial Manual

1) Circulate the chapters approved by the BSC to Member Countries

for first-round comment October 2021

2) Remind authors of the chapters identified previously for update but

not yet received and invite authors of chapters newly identified for

update

On-going

3) Create a list of OIE validated tests to be published on the OIE

Website

a) Develop a template for the validation data that would be requested of 

applicants wishing to add their test to a future list For February 2022

4) Add a new section to the disease-specific chapters to describe the

rationale behind the selection of tests for different purposes given in

Table 1 Test methods available and their purpose and an

explanation for their score. Eventually, add links to the link of

validated tests mentioned above

a) Develop a template for this new section. For February 2022

Collaborating Centres

1) Implementation of the adopted SOPs: For February 2022

a) review the final “map” that has resulted from the mapping exercise February 2022

b) review the remaining submitted or re-submitted 5-year work plans February 2022

2) Send feedback to Centres re: review of annual reports 2020 October 2021

Reference Laboratories

1) Put under-performing labs on watch list October 2021

2) Follow up of in-depth review of all annual reports for activities 2018

onwards: create document detailing past history of annual reports, For February 2022

Reference Centre Networks

1) Follow up with the three newly launched Reference Laboratory

networks (ASF, PPR and rabies) On-going

Standardisation/

Harmonisation

1) Project to extend the list of OIE approved reference reagents On-going

2) Update the existing guidelines, and include a template as an annex

for the data to be submitted with a request for approval to be added

to the list of approved reagents

On-going

3) Project to develop Replacement International Standard Bovine

Tuberculin: finalise report and propose for adoption For February 2022

4) Review the conclusions from the OIE Scientific and Technical

Review issue on diagnostic test validation science re: the OIE

Procedure for the Registration of Diagnostic Kits

February 2022

Ad hoc Groups

1) Ad hoc Group on Sustainable Laboratories On-going

2) Ad hoc Group on the revision of Terrestrial Code chapters

regarding the collection and processing of semen of animals On-going

Projects

1) Veterinary Biobanking (project) Ongoing 

2) High Throughput Sequencing and Bioinformatics and

Computational Genomics (HTS-BCG) On hold awaiting funding

UNOFFICIAL VERSION
Annex 4 (contd) Work Programme for the OIE Biological Standards Commission

36 Biological Standards Commission/September 2021

Subject Issue Status and Action

Conferences, Workshops 

and Meetings with 

participation by BSC 

Members

1) Biosafety research roadmap Ongoing

2) ISWAVLD OIE seminar: theme and programme and speakers June 2023

Performance Engaging with the ongoing processes around performance issues with 

Reference Labs On-going

Twinning Programme Assess the status of the post-twinning labs: dashboard. Gather 

feedback from the labs, way forward. Review geographical distribution For September 2022

Develop laboratory 

standards for emerging 

diseases

1) Discuss the Terrestrial Code chapter once adopted with the aim of 

introducing a corresponding chapter for the Terrestrial Manual After May 2022

__________

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