OIE RL for Scrapie and Chronic Wasting Disease (CWD) Dr. Aru Balachandran Canada

OIE RL for « Scrapie and Chronic Wasting Disease (CWD) » – « Dr. Aru Balachandran » – « Canada »

OIE Reference Laboratory Reports
Activities in 2012

Name of disease (or topic) for which you are a designated OIE Reference Laboratory: / Scrapie and Chronic Wasting Disease
Address of laboratory / Canadian Food Inspection Agency
Ottawa Laboratory-Fallowfield
3851 Fallowfield Rd, Ottawa, ON K2H8P9
Canada
Tel.: / 613-228-6698
Fax: / 613-221-6103
e-mail address: /
website: / http://www.inspection.gc.ca/english/toce.shtml
Name (including Title) of Head of Laboratory (Responsible Official): / Karen Jesset
Executive Director, Ontario Laboratory Network
Canadian Food Inspection Agency
Name(including Title and Position) of OIE Reference Expert: / Dr. Aru Balachandran
Veterinary Science Advisor; Head, National and OIE Reference Laboratory for Scrapie and CWD
Date of submission to the OIE / 2013/01/25

ToR: To use, promote and disseminate diagnostic methods validated according to OIE Standards

Disease / Test / For / Specificity / Total
Scrapie / IHC / Antigen / PrP Sc / 1069
BioRad ELISA / Antigen / PrP Sc / 7410
VLA Hybrid & BioRad TeSeE-Confirm WB / Antigen / PrP Sc / 97
Genotyping sheep / Codon136,154,171 / 2518
CWD / IHC / Antigen / PrP CWD / 704
ELISA / Antigen / PrP CWD / 1316
VLA Hybrid & BioRad TeSeE-Confirmatory WB / Antigen / PrP CWD / 80
Genotyping-Elk, white-tailed deer / Codon132, 96 / 152
BSE / ELISA / Antigen / PrP BSE / 4990
AMR / IHC / Antigen / GFAP / 316

ToR: To develop reference material in accordance with OIE requirements, and implement and promote the application of OIE Standards.

To store and distribute to national laboratories biological reference products and any other reagents used in the diagnosis and control of the designated pathogens or disease.

2. Did your laboratory produce or store imported standard reference reagents officially recognised by the OIE or other international bodies?

Yes No

3. Did your laboratory supply standard reference reagents to OIE Member Countries?

Yes No

While most diagnostic reagents required for scrapie and CWD testing are commercially available, we continue to develop and maintain an archive of TSE-positive and negative reference materials for use in test development, validation and proficiency testing programs. These materials are used nationally within our reference and network laboratories and have been provided to countries in North and South America and Asia who are seeking to develop TSE testing programs or validate existing programs.

4. Did your laboratory produce diagnostic reagents other than the OIE-approved standard reference reagents?

Yes No

5. Did your laboratory produce vaccines?

Yes No

6. Did your laboratory supply vaccines to OIE Member Countries?

Yes No

ToR: To develop, standardise and validate, according to OIE Standards, new procedures for diagnosis and control of the designated pathogens or diseases

7. Did your laboratory develop new diagnostic methods validated according to OIE Standards for the designated pathogen or disease?

Yes No

8. Did your laboratory develop new vaccines according to OIE Standards for the designated pathogen or disease?

Yes No

Name of the new test or diagnostic method or vaccine developed / Description and References (Publication, website, etc.)
Cell culture for the in vitro detection of prion infectivity / The requirement for rapid and robust assays to detect of low levels of prion proteins in a variety of sample matricies continues. Cell culture based systems have recently demonstrated utility in the detection of scrapie and CWD, and we continue to refine analytical sensitivity towards broader diagnostic and research applications.
Evaluation of immuno-PCR for the detection of ulta-low levels of pathologic prion protein / Current testing methods for transmissible spongiform encephalopathies (TSEs) involve the detection of abnormal prion protein (PrPTSE) by immunochemical methods as the hallmark of infection. Novel technologies that combine higher sensitivity detection with fast, robust, and cost-efficient protocols hold promise for future diagnostic and research applications. Work is in progress to increase the analytical sensitivity of immuno-PCR relative to currently approved test methods and to investigate the applicability for pre-clinical diagnosis and environmental testing.
Cervid genotyping for CWD resistance/susceptibility / Susceptibility of cervids to CWD infection has been shown to be associated with polymorphisms in the host prion protein gene. Work is in progress to validate recently developed high throughput methods to detect the allelic variants of elk, white-tailed deer at codons 132, and 96 respectively. This information may be used as a component of regulatory control and eradication programs. Measures of sensitivity and specificity do not apply as per diagnostic testing of a disease/infectious agents since this test provides the genotype of a particular animal and not infected/non-infected status. The method used to detect these allelic variants has undergone partial Level 1 formal validation in accordance with the OIE Validation Template (calibration, repeatability studies).
Rodent bioassay for the quantification and characterization of prion infectivity / The rodent bioassay platform continues to develop towards characterising Canadian scrapie and CWD strain variability, investigating species barriers to infectivity and determining infectivity titres from a variety of matrices. Diagnostic utility has been demonstrated in differentiating between CWD, atypical and classical scrapie and BSE in field samples. The ability to quantify infectivity enables the development and validation of novel ultrasensitive tests such as PMCA, immuno-PCR, RT-QuIC and cell culture.
Contact : Animal Health Research and Partnership Division, Canadian Food Inspection Agency Floor 1, Room 314, 1400, Merivale Road, Tower 1, Ottawa , Ontario, K1A 0Y0 Canada,

ToR: To provide diagnostic testing facilities, and, where appropriate, scientific and technical advice on disease control measures to OIE Member Countries

9. Did your laboratory carry out diagnostic testing for other OIE Member Countries?

Yes No

Name of OIE Member Country seeking assistance / Date
(dd/mm) / No. samples received for provision of diagnostic support (i.e. from surveillance campaign) / No. samples received for provision of confirmatory diagnoses
Brazil / 12/10 / 92 / 0

10. Did your laboratory provide expert advice in technical consultancies on the request of an OIE Member Country?

Yes No

Name of the OIE Member Country receiving a technical consultancy / Purpose / How the advice was provided
Republic of Korea / Dr. Min-Jeong Kim of the Prion Disease Research Laboratory from Animal, Plant, and Fisheries Quarantine and Inspection Agency spent a week in the TSE lab training in diagnostic test methodology and result interpretation. / Visit to OLF-CFIA
Canada
Republic of Korea / Dr. Aru Balachandran: Site visit to QIA lab for consultation on collaborative research underway. / Visit to QIA, South Korea
Japan / Dr. Takashi Yokoyama, head of the Prion Diseases Research Unit from the National Institute of Animal Health and Dr. Motohiro Horiuchi, of Hokkaido University, presented their labs developments and novel approaches with Prion diseases. / Visit to OLF-CIFA
Canada
China / Dr. Ma Guiping, China's leading advisor on TSEs in AQSIQ, visited Canada to exchange technical knowledge on BSE and CWD with CFIA laboratories and to learn more about Canadian federal, provincial and industry programs related to these issues. / Visit to OLF-CFIA
Canada
Taiwan / Drs. Jen-Chieh Chang and Jen-Huan Tsai from the Animal Health Research Institute, Taipei spent a week in our laboratory for technical training on various TSE diagnostic methodologies. / Visit to OLF-CFIA
Canada

ToR: To carry out and/or coordinate scientific and technical studies in collaboration with other laboratories, centres or organisations

11. Did your laboratory participate in international scientific studies in collaboration with OIE Member Countries other than the own?

Yes No

Title of the study / Duration / Purpose of the study / Partners (Institutions) / OIE Member Countries involved other than your country
Investigating cross-species transmission of CWD / On-going / To characterize South Korean and Canadian chronic wasting disease strains using cervid and transgenic mouse models. / Dr. Hyun-Joo Sohn, Dr. Yoon-Hee Lee, Dr. Min-Jeong Kim, Dr. In-Soo Cho :Veterinary Researchers at QIA, South Korea. / Republic of Korea

ToR: To collect, process, analyse, publish and disseminate epizootiological data relevant to the designated pathogens or diseases

12. Did your Laboratory collect epizootiological data relevant to international disease control?

Yes No

13. Did your laboratory disseminate epizootiological data that had been processed and analysed?

Yes No

14. What method of dissemination of information is most often used by your laboratory?

(Indicate in the appropriate box the number by category)

a)  Articles published in peer-reviewed journals: 6

b)  International conferences: 3

c)  National conferences: X

d)  Other:

ToR: To provide scientific and technical training for personnel from OIE Member Countries

To recommend the prescribed and alternative tests or vaccines as OIE Standards

15. Did your laboratory provide scientific and technical training to laboratory personnel from other OIE Member Countries?

Yes No

If the answer is yes, please provide the total number of trained persons for each of the following categories:

a)  Technical visits: 3

b)  Seminars:

c)  Hands-ontraining courses:

d)  Internships (>1 month):

Type of technical training provided (a, b,c or d) / Country of origin of the expert(s) provided with training / No. participants from the corresponding country
A / Taiwan / 2
A / Republic of Korea / 1

ToR: To maintain a system of quality assurance, biosafety and biosecurity relevant for the pathogen and the disease concerned

16. Does your laboratory have a Quality Management System certified according to an International Standard?

Yes No

Quality management system adopted
ISO 17025

17. Is your laboratory accredited by an international accreditation body?

Yes No

Test for which your laboratory is accredited / Accreditation body
Detection of spinal cord in beef contaminated meat products by H&E, and GFAP IHC staining / SCC
Detection of abnormal prion protein for BSE, Scrapie and CWD Diagnosis by Bio-Rad ELISA / SCC
Genotyping Sheep for Scrapie Suceptibility/Resistance by Real-Time PCR / SCC
Confirmation of prion protein specific for scrapie and CWD using Bio-Rad’s TeSeE Western Blot Kit / SCC
Immunohistochemical detection of prion protein in animal TSEs: Scrapie in Sheep and Goats / SCC
Immunohistochemical detection of prion protein in animal TSEs: Chronic wasting disease (CWD) in Deer and Elk / SCC

18. Does your laboratory maintain a “biorisk management system” for the pathogen and the disease concerned? (See Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2012, Chapter 1.1.3 or Manual of Diagnostic Tests for Aquatic Animals 2012, Chapter 1.1.1)

Yes No

ToR: To organise and participate in scientific meetings on behalf of the OIE

19. Did your laboratory organise scientific meetings on behalf of the OIE?

Yes No

20. Did your laboratory participate in scientific meetings on behalf of the OIE?

Yes No

Title of event / Date
(mm/yy) / Location / Role (speaker, presenting poster, short communications) / Title of the work presented
Prion 2012 / 05/12 / Amsterdam, Netherlands / Speaker / Chronic Wasting Disease (CWD) in Canada: Update on cross-species transmission studies
Annual meeting of the American College of Veterinary Pathologists / 12/12 / Seattle, Washington, USA / Poster presentation / Characterization of Canadian CWD isolates in transgenic mice.
1st QIA Workshop and Hands-on training on CWD and other prion diseases, in collaboration with the CFIA, Canada and the NIAH, Japan / 6/12 / QIA, Republic of Korea / Speaker / TSEs of small ruminants and cervids in Canada

ToR: To establish and maintain a network with other OIE Reference Laboratories designated for the same pathogen or disease and organise regular inter-laboratory proficiency testing to ensure comparability of results

21. Did your laboratory exchange information with other OIE Reference Laboratories designated for the same pathogen or disease?

Yes No

22. Was your laboratory involved in maintaining a network with OIE Reference Laboratories designated for the same pathogen or disease by organising or participating in proficiency tests?

Yes No

23. Did your laboratory collaborate with other OIE Reference Laboratories for the same disease on scientific research projects for the diagnosis or control of the pathogen of interest?

Yes No

Title of the project or contact / Scope / Name(s) of relevant OIE Reference Laboratories
Investigating cross-species transmission of CWD / To characterize South Korean and Canadian chronic wasting disease strains using cervid and transgenic mouse models. / Animal, Plant and Fisheries Quarantine and Inspection Agency, Republic of Korea.

ToR: To organise inter-laboratory proficiency testing with laboratories other than OIE Reference Laboratories for the same pathogens and diseases to ensure equivalence of results.

24. Did your laboratory organise or participate in inter-laboratory proficiency tests with laboratories other than OIE Reference Laboratories for the same disease?

Yes No

Purpose for inter-laboratory test comparisons[1] / No. participating laboratories / Participating OIE Member Countries /
Validation of IHC testing for scrapie and CWD / 2 / USDA, Pullman WA and Colorado State Veterinary laboratory, Fort Collins, CO
USA

ToR: To place expert consultants at the disposal of the OIE

25. Did your laboratory place expert consultants at the disposal of the OIE?

Yes No

Scientific Publications in peer-reviewed journals

Biodegradation of specified risk material and fate of scrapie prions in compost.

Xu S, Reuter T, Gilroyed BH, Dudas S, Graham C, Neumann NF, Balachandran A, Czub S, Belosevic M, Leonard JJ, McAllister TA.

J Environ Sci Health A Tox Hazard Subst Environ Eng. 2013;48(1):26-36.

Strain Characterization of the Korean CWD Cases in 2001 and 2004.

Lee YH, Sohn HJ, Kim MJ, Kim HJ, Lee WY, Yun EI, Tark DS, Cho IS, Balachandran A.

J Vet Med Sci. 2012 Aug 28

Diagnostic accuracy of rectal mucosa biopsy testing for chronic wasting disease within white-tailed deer (Odocoileus virginianus) herds in North America: effects of age, sex, polymorphism at PRNP codon 96, and disease progression.

Thomsen BV, Schneider DA, O'Rourke KI, Gidlewski T, McLane J, Allen RW, McIsaac AA, Mitchell GB, Keane DP, Spraker TR, Balachandran A.

J Vet Diagn Invest. 2012 Sep;24(5):878-87

Experimental oral transmission of chronic wasting disease to reindeer (Rangifer tarandus tarandus).

Mitchell GB, Sigurdson CJ, O'Rourke KI, Algire J, Harrington NP, Walther I, Spraker TR, Balachandran A.