Activities in 2009
Diagnosis of Animal Diseases and Vaccine
Evaluation for the Americas
Dr E. A. Lautner
National Veterinary Services Laboratories, VS, APHIS, USDA
P.O. Box 844, 1920 Dayton Avenue, Ames, Iowa 50010, United States of America
Tel.: (1-515) 337-7266, Fax: (1-515) 337-7397
elizabeth.a.lautner@aphis.usda.gov; www.aphis.usda.gov/animal_health/lab_info_services
Dr R. E. Hill, Jr
Center for Veterinary Biologics, VS, APHIS, USDA
P.O. Box 844, 1920 Dayton Avenue, Ames, Iowa 50010, United States of America
Tel.: (1-515) 337-7266, Fax: (1-515) 337-7397
rick.e.hill@aphis.usda.gov; www.aphis.usda.gov/animal_health/vet_biologics
Summary of activities specifically related to the mandate of
OIE Collaborating Centres
1.
Activities as a centre of research, expertise, standardisation and dissemination of techniques
within the remit of the mandate given by the OIE
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Served on the tripartite (U.S.-Canada-Mexico) North American Foot-and Mouth Disease (FMD) Vaccine
Bank Technical Committee (NAFMDVB TC). The NAFMDVB TC meets to address preparedness issues
related to vaccine availability and use in the event of an outbreak of FMD in Canada, Mexico, or the United
States.
Operation of the North American Foot and Mouth Disease Vaccine Bank (NAFMDVB), including the testing
of FMD vaccines for safety, potency, purity, and stability according to the established agreement between
Canada, Mexico and the USA.
Worked with the National Association of State Public Health Veterinarians (NASPHV) to contribute to the
annual Rabies Compendium posted at http://www.nasphv.org. The NASPHV Compendia provide
standardized national recommendations for key zoonotic disease issues involving rabies.
Conducted inspections of various veterinary biologics manufacturing facilities in Argentina, Australia, Czech
Republic, France, Germany, Republic of Korea, Mexico, and United Kingdom that produce biologics
imported into the United States.
Met with government and biologics industry personnel from China, Germany and New Zealand to provide
information on the U.S. inspection, testing, review and approval processes for biologics.
Provided reagents for the evaluation of biologics to member countries (Australia, Canada, Columbia,
Mexico, Netherlands, Turkey, United Kingdom).
Met with representatives from China’s Institute of Veterinary Drug Control. The representatives were visiting
to obtain a better understanding of the National Veterinary Services Laboratories (NVSL) and the Center for
Veterinary Biologics (CVB) role as an OIE Collaborative Center.
Participated as members of the U.S. team for the Laboratory Procedures Harmonization for Bovine
Tuberculosis between U.S.-Canada-Mexico.
The NVSL generated and analyzed data on the 2009 CEM outbreak in the U.S. Data are currently being
prepared for publication.
The NVSL provided guidance on CEM testing questions from Canada, Mexico, and Thailand.
Personnel from NVSL participated in Leptospira proficiency tests distributed by the Australian National
Quality Assurance Program (ANQAP).
Provided diagnostic reagents to member countries (Argentina, Australia, Austria, Azerviajan, Belgium,
Bolivia, Botswana, Brazil, Cambodia, Canada, Chile, China, Colombia, Czech Republic, Denmark, El
Salvador, Estonia, Finland, France, Germany, Greece, India, Italy, Japan, Jordan, Korea, Kuwait, Latvia,
Annual reports of OIE Reference Laboratories and Collaborating Centres, 2009
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National Veterinary Services Laboratories/Center for Veterinary Biologics
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Proposal or development of any procedure that will facilitate harmonisation of international
regulations applicable to the surveillance and control of animal diseases, food safety or animal
welfare
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Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Paraguay, Peru,
Philippines, Poland, Portugal, Scotland, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland,
Thailand, Trinidad, Tunisia, Turkey, UAE/Dubai, United Kingdom, West Indies).
Shared diagnostic information with visitors from Argentina, Australia, Brazil, Canada, China, Dominican
Republic, Georgia, Germany, Iraq, Italy, Mexico, Morocco, Saudi Arabia, Serbia, Taiwan, Tajikistan,
Ukraine, and the United Kingdom.
Invited speakers at the World Association of Veterinary Laboratory Diagnosticians held in Madrid, Spain,
June 16 – 20, 2009. The National Animal Health Laboratory Network (NAHLN) sponsored a pre-meeting
symposium titled, “Development and Implementation of Veterinary Diagnostic Laboratory Networks:
Principles of Laboratory Network Development and Function.”
Provided 43 standard operating procedures (SOPs) to international countries in 2009.
Participated in a meeting at SAGARPA-Mexico City to discuss the diagnostic approach, and to better define
established surveillance plan, for early detection of classical swine fever.
Participated at the OIE/FAO FMD Reference Laboratories Network Meeting from Nov 23-27, 2009 in New
Delhi, India.
Conducted a complete diagnostic workup on submissions from Iraq, Nigeria, and Pakistan, including
sequencing and phylogenetic analysis.
The NVSL is currently developing a method for the isolation of Bacillus anthracis from animal wool and
hide. The current method used is difficult due to high levels of contamination with rapid growers and other
spore formers. We are evaluating the efficacy of various procedure used for the isolation of Bacillus
anthracis from environmental and animal products and are developing a selective enrichment broth.
The NVSL refined and implemented a pulsed-field gel electrophoresis assay for Taylorella. This assay was
used to analyze strains of Taylorella from the U.S. and other countries. The NVSL is also initiating a project
to sequence the Taylorella equigenitalis genome in hopes of developing improved diagnostic tests in the
future.
The NVSL worked with other CEM OIE reference laboratories to obtain strains of Taylorella from various
geographic regions for molecular analysis.
Provided proficiency panels for Brucella serology, anaplasmosis, equine infectious anemia, bluetongue,
bovine leukosis, bovine tuberculosis (Bovigam), and bovine spongiform encephalopathy to laboratories in the
U.S.A.
The NVSL is a member of the North American Animal Health Laboratory Network (NAAHLN) (Canada,
Mexico, and the United States) formed to enhance detection of avian influenza, vesicular diseases and
tuberculosis. The goal of the network is to identify gaps in diagnostic testing, harmonize testing protocols,
share reagents, provide training where and when necessary, and exchange proficiency test samples to ensure
reliability of diagnostic testing between the network laboratories. Participating laboratories met in La Paz,
MX to discuss bovine tuberculosis on March 3-4, 2009 and avian influenza on March 6, 2009.
The International Cooperation on Harmonization of Technical Requirements for the Registration of
Veterinary Medicinal Products (VICH) is a unique project that brings together the regulatory authorities of
the European Union, Japan, and the United States and representatives from the animal health industry in the
three regions to harmonize technical requirements for the registration of veterinary products (both drugs and
biologics). The CVB serves on the VICH Steering Committee as the U.S. representative for veterinary
biological products. 2009 meetings were held in Ottawa, Canada, and Kobe, Japan. The primary "products"
of the VICH are harmonized Guidelines which represent scientific consensus regarding regulatory
requirements for the three regions.
Provided personnel to VICH Expert Working Groups created to draft and recommend harmonized biologics
guidelines for Quality Monitoring, Pharmacovigilance, and Target Animal Safety.
Attended a meeting of the Controlled Lists of Terms Task Force, formed as a subgroup of the VICH
Pharmacovigilance Expert Working Group, in Tokyo, Japan. The group, consisting of representatives from
the veterinary medicinal products industry and regulatory agencies of Japan, the European Union,
Australia/New Zealand, Canada, and United States, met to finalize the lists of terms to be incorporated into
the harmonized guidelines for the reporting adverse events following the use of veterinary medicinal
products. The group also finalized and agreed upon the Off-Label Use coding process.
Provided Johne’s disease serology and milk ELISA diagnostic proficiency panels to laboratories in Canada,
United Kingdom, The Netherlands, Chile, and U.S.A.
Annual reports of OIE Reference Laboratories and Collaborating Centres, 2009
National Veterinary Services Laboratories/Center for Veterinary Biologics
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Provided Classical Swine Fever and Foot and Mouth Disease proficiency panels to laboratories in U.S.,
Canada, and Mexico.
Plum Island Animal Disease Center-Foreign Animal Disease Diagnostic Laboratories (PIADC-FADDL) sent
harmonization panels for FMD to laboratories in Canada and Mexico
As a result of participation in the OIE/FAO FMD Reference Laboratories Network Meeting, Dr. Metwally
was selected to represent PIADC-FADDL and the US as part of working group for assay harmonization for
FMD diagnostics.
Placement of expert consultants at the disposal of the OIE
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Participated in the International Association for Biologicals Viral Safety and Extraneous Agents Testing
workshop in Annecy, France. The workshop featured attendees from the fields of veterinary vaccine safety,
industry, academia, research facilities, and regulatory authorities, and will focus on the review and evaluation
of current procedures and purity standards.
Participated in 1st Iraqi Animal Health Association Meeting, held in Baghdad, to give presentations and
participate in discussions on vaccine production and quality control.
Participated in the Veterinary Dictionary for Drug Related Affairs subgroup meeting of the European
Medicines Evaluations Agency, held in the United Kingdom.
Participated in a training course in support of the United Nations Secretary General’s Mechanism for
Investigation of Alleged Use of Biological Weapons. A multidisciplinary group of scientists and experts in
munitions from 16 nations attended the course held in Umeå, Sweden.
Participated in the National Veterinary Stockpile African Swine Fever (ASF) Countermeasures Expert
Working Group meeting held in Madrid, Spain. The purpose of the meeting was to assist in the evaluation of
available ASF countermeasures, particularly vaccines and diagnostic test kits.
Participated in the National Veterinary Stockpile logistics planning meeting, held in Buenos Aires,
Argentina, to discuss preparation and delivery of Foot and Mouth Disease vaccines.
Provided disease experts to lecture on equine piroplasmosis, arboviruses, equine infectious anemia, vesicular
stomatitis, avian influenza, Newcastle Disease, equine arbovirus encephalitis, bluetongue and epizootic
hemorrhagic disease.
The Designated Expert on Bluetongue participated in the Second Meeting of the OIE Bluetongue Network in
Torre di Cerrano, Italy, 1-2 June 2009
Participated in the 2nd OFFLU meeting of influenza technical experts, Paris, France (Sept 15-16, 2009) to
develop guidelines for highly pathogenic avian influenza subtype H5 and pandemic H1N1 influenza testing.
Performed a laboratory assessment for diagnosis of avian influenza and Newcastle disease for OIE Twinning
Project with Brazil
A member of the NVSL staff participated in a FAO mission to Mexico (Mexico-United States Commission
for the Prevention of Foot and Mouth Disease and Other Exotic Diseases of Animals [CPA]) to standardize
testing for pH1N1 (2009) influenza.
Participated in the global Rinderpest Eradiation Programme in Rome on June 2-3, 2009. Discussion focused
on the control of the rinderpest virus remaining in laboratories.
Serves as a swine influenza reference laboratory and disease expert for OFFLU. Activities include being
available to provide diagnostic tests, reagents, and SOPs to other countries. Provides written information and
reviews documents necessary for OFFLU. Attends meetings and conference calls as necessary to support
OFFLU functions
Provided laboratory expertise on FAO mission trip to the Philippines to investigate Ebola-Reston virus in
swine.
Other activities related to the mandate
of OIE Collaborating Centres
4.
Provision of scientific and technical training, within the remit of the mandate given by the OIE, to
personnel from OIE Members
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In March 2009, the NVSL provided a prompt diagnosis for the outbreak of swine teschovirus
encephalomyelitis in the Republic of Haiti. In May 2009, NVSL staff visited affected regions in Haiti. In
June 2009, the FAO sent a mission team to Haiti to conduct a field evaluation on the disease. NVSL staff
provides technical assistance in FAO’s efforts of vaccine development and production.
Annual reports of OIE Reference Laboratories and Collaborating Centres, 2009
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National Veterinary Services Laboratories/Center for Veterinary Biologics
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5.
The NVSL provided online training session to the Iraqi Veterinarians on FMD diagnostics and complexity to
control. This training was supported by the US Department of State.
The 2009 Institute for International Cooperation in Animal Biologics (IICAB) Veterinary Biologics Training
Program (VBTP) was held in Ames, Iowa. Participants are regulatory officials from countries throughout the
world and biologics company employees. The IICAB VBTP represents a major effort in the international
harmonization of requirements for veterinary biologics, in that regulatory authorities from around the world
are instructed in the U.S. method of assuring the quality of veterinary vaccines, diagnostics, and
immunotherapeutics. Approximately 30 CVB personnel participated as faculty.
The NVSL provides training courses (5 courses per year) on foreign animal diseases to veterinary students,
university professors and veterinarians from all over the United States and other countries. These two-week
courses include lectures, clinical rounds and necropsy of animals that are experimentally infected with
various foreign animal diseases. In 2009, there were participants from Chile, Panama, Mexico, Peru, Haiti,
Honduras, Argentina, and Brazil.
In February 2009, a member of the NVSL staff provided lectures and clinical training in disease recognition
of highly pathogenic avian influenza to 30 Canadian Food Inspection Agency veterinarians at the National
Centre for Foreign Animal Diseases, Winnipeg, Canada.
In February-March 2009, NVSL staff trained two scientists from Brazil in avian influenza and Newcastle
diagnostic procedures and reagent production.
The NVSL holds several routine technical training courses each year. In 2009, training courses on bovine
spongiform encephalopathy and Johne’s disease isolation and identification included foreign participants.
Training on the diagnosis of classical swine fever by the PCR method was provided to the Dominican
Republic.
On September 14-15, 2009, the NVSL provided instruction at the International Course of Transboundary
Animal Disease (ICTAD), held on Plum Island, New York. Twenty-three participants attended the course
and represented the following South and Central American countries: Panama, Columbia, Argentina, Brazil,
Guatemala, Chile, Mexico, Dominican Republic, Bolivia, Paraguay, El Salvador and Haiti.
Organisation of scientific meetings on behalf of the OIE
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6.
Coordination of scientific and technical studies in collaboration with other laboratories,
organisations or collaborating centres
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Collaboration with Canada, Mexico, and New Zealand on an international project entitled: “Comparison of
North American Mycobacterium bovis and Mycobacterium avium tuberculin PPDs in vivo (comparative
cervical testing) and validation of additional diagnostics for tuberculosis in cattle.”
Collaboration with CENASA-INIFAP-SAGARPA, Mexico on the molecular epidemiology of
Mycobacterium bovis from Mexico and the United States.
Collaborated with Pirbright and Smith Detection Systems on a LATE PCR-based penside test. (ongoing)
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Collaborating with Svanova Biotech and Pakistan to test Svanova’s FMD-Ag penside devices in the field.
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Collaborating on various animal studies so that NVSL can have additional clinical samples for evaluation and
assay validation purposes.
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Collaboration with National Institute for Biotechnology and Genetic Engineering, Faisalabad, Pakistan,
regarding identification of foot-and-mouth disease virus in samples collected from December 2008-February
2009. Analysis included virus isolation, real-time RT-PCR and nucleotide sequence analysis.
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Participated in the diagnosis, serotyping, isolation, and sequencing of foot-and-mouth virus from infected
animal samples from Iraq.
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Performed diagnostics on 30 tissue samples and 532 sera submitted from Nigeria, during an outbreak where
the morbidity rate was between 50% and 80%, though no mortality was reported. Serology, serotyping,
isolation and sequencing of FMD virus, and phylogenetic analysis were performed.
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Annual reports of OIE Reference Laboratories and Collaborating Centres, 2009
National Veterinary Services Laboratories/Center for Veterinary Biologics
7.
Publication and dissemination of any information within the remit of the mandate given by the
OIE that may be useful to Members of the OIE
Represented the United States at the OIE XV Seminar on Harmonization and Control of Veterinary Drugs hosted
by the OIE Region of the Americas Committee on Veterinary Medicines (CAMEVET) in Mexico. Participated in
a workshop held by the US Food and Drug Administration and USDA that included presentations on the methods
applied in the registration of generic products and the setting of withdrawal periods.
Provided OIE/IICAB 2009 Veterinary Biologics Training Program lecture notes and reference materials.
2009 USAHA Dossier Reports
Avian influenza matrix (H5 and H7) rRT-PCR
pH1N1 influenza differential matrix rRT-PCR
Influenza N1 rRT-PCR
Publications
Barrette RW, S Metwally, J Rowland, L Xu, S Zaki, S Nichol, P Rollin, J Towner, W Shieh, B Batten, T Sealy, C
Carrillo, K Moran, A Bracht, G Mayr, M Sirios-Cruz, D Catbagan E Lautner, T Ksiazek, W White, M McIntosh.
(2009). Discovery of swine as a host for the Reston Ebolavirus. Science 325(5937):204-206.
Coffee, LL, BA Hanson, MP Luttrell, DE Swayne, DA Senne, VH Goekjian, LJ Niles, and DE Stallknecht.
(2009). Avian paramyxoviruses in Charadriform birds. J Wildlife Dis. In press.
Corn, J., P. Berger, and J. Mertins. (2009). Surveys for Ectoparasites on Wildlife Associated Amblyomma
variegatum (Acari: Ixodidae)-Infested Livestock in St. Croix, U.S. Virgin Islands. J Med Entomol, 46(6): 14831489.
Fernandez-Sainz I, Holinka LG, Gavrilov BK, Prarat M. V, Gladue D, Lu Z., Jia W, Risatti GR, Borca MV.
(2009). Alteration of the N-linked glycosylation condition in E1 glycoprotein of Classical Swine Fever Virus
strain Brescia alters virulence in swine. Virology, 386(1):210-216.
Greenwald, R., O. Lyashchenko, J. Esfandiari, M. Miller, S. Mikota, J. H. Olsen, R. Ball, G. Dumonceaux, D.
Schmitt, T. Moller, J.B. Payeur, B. Harris, D. Sofranko, W. R. Waters, and K.P. Lyashchenko. 2009. Highly
accurate antibody assays for early and rapid detection of tuberculosis in African and Asian elephants. Clin Vaccine
Immunol. 2009 May;16(5):605-12.
Hao, Y, TS Senn, J Opp, VB Young, T Thiele, G Srinivas, SK Huang, DM Aronoff. (2009). Lethal toxin is a
critical determinant of rapid mortality in rodent models of Clostridium sordellii endometritis. Anaerobe. 2009 Jun
13 (E-Publication ahead of print).
Harris, B., S. Robbe-Austerman, P. Dykema, K. Fett, T. Stuber, and K. Stokes. 2009. Laboratory Methods for
Isolation and Identification of Mycobacterium avium ssp. Paratuberculosis. (Manual distributed by NVSL)
Kapil S, T. Yeary, JF Evermann. Viral diseases of the new world camelids. Vet Clin North Am Food Animal
Pract. 2009 Jul:25(2):323-37.
Mertins, J., B. Hanson, and J. Corn. 2009. Whartonacarus floridensis sp. Nov. (Acari: Trombiculidae), with a
Taxonomic Review and the First Record of Whartonacarus Chiggers in the Continental United States. J Med
Entomol, 46(6): 1260-1268.
Loiacono CM, BV Thomsen, SM Hall, M Kiupel, D Sutoon, K O’Rourke, B Barr, L Anthenill, D. Keane. (2009)
Nor98 Scrapie identified in the United States. J Vet Diag Invest 21(4): 454-463.
Lorusso, A., KS Faaberg, ML Killian L Koster, AL Vincent. (2009). One-step real-time RT-PCR for pandemic
influenza A virus (H1N1) 209 matrix gene detection in swine samples. J Virol Meth. E-Published 18 December
2009 ahead of print.
Annual reports of OIE Reference Laboratories and Collaborating Centres, 2009
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National Veterinary Services Laboratories/Center for Veterinary Biologics
Pedersen, JC, ML Killian, NL Hines, DA Senne, B Panigrahy, HS Ip, and E Spackman. (2009). Validation of a
real-time RT-PCR assay for the detection of H7 avian influenza virus. Avian Dis (Special Issue). In press.
Senne, DA. (2009). Avian influenza in North and South America, the Caribbean, and Australia, 2006-2008. Avian
Dis (Special Issue). In press.
Sim YJ, S. Yu, KL Yoon, C Loiacono, M. Kohut. (2009) Chronic exercise reduced illness severity, decreases viral
load, and results in greater anti-inflammatory effects than acute exercise during influenza infection. J Infect Dis,
200(9): 1434-1442
Stabel JR, Palmer MV, Harris B, Plattner B, Hostetter J, Robbe-Austerman S. 2009. Pathogenesis of
Mycobacterium avium subsp. paratuberculosis in neonatal calves after oral or intraperitoneal experimental
infection. Vet Microbiol. 2009 May 12;136(3-4):306-13.
Valarcher JF, Knowles NJ, Zakharov V, Scherbakov A, Zhang Z, Shang YJ, Liu ZX, Liu XT, Sanyal A, Hemadri
D, Tosh C, Rasool TJ, Pattnaik B, Schumann KR, Beckham TR, Linchongsubongkoch W, Ferris NP, Roeder PL,
Paton DJ. Multiple origins of foot-and-mouth disease virus serotype Asia 1 outbreaks, 2003-2007. Emerg Infect
Dis. 2009 Jul;15(7):1046-51.
Waters, W.R., A. O. Whelan, K.P. Lyashchenko, R. Greenwald, M.V. Palmer, B.N. Harris, R.G. Hewinson, and
H.M. Vordermeier. 2009. Immune Responses in Cattle Inoculated with Mycobacterium bovis, Mycobacterium
tuberculosis, or Mycobacterium kansasii. Clin. Vaccine Immunol. [Epub ahead of print]
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Annual reports of OIE Reference Laboratories and Collaborating Centres, 2009