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Animal Health

Scrapie Disease Information

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Approved Laboratories for Scrapie Testing

Scrapie Genetic Susceptibility Testing

General Information

Genetic Resistance to Scrapie (pdf 16kb) - Basic information on genetics and scrapie resistance and information on how APHIS is using genetic testing to help eradicate scrapie.

Genotype testing for susceptibility to scrapie is a key element of the Scrapie Eradication Program.  Consequently, the Animal and Plant Health Inspection Service (APHIS) has approved the following companies to perform sheep genotyping for the prion protein gene at codons 136, 154, and 171 in an official capacity for the National Scrapie Eradication Program (NSEP).  This approval is in accordance with Title 9, Code of Federal Regulations, Part 54.11 and Veterinary Services Memorandum Number 557.6.

Approved Genotyping Laboratories

The approved laboratories are eligible to conduct privately funded official scrapie genotype testing and compete for NSEP funded official genotyping.  This approval lasts for 1 year and is subject to review and renewal.

Each laboratory applied for approval to conduct official genotype tests.  The approval process begins by the laboratory sending an application package to the National Veterinary Services Laboratory (NVSL). The application must contain the following information about the laboratory:

  1. Name and address of the laboratory.
  2. Name of the legally responsible official and, if different, the director of the laboratory.
  3. A description of the laboratory facilities and equipment that will be used in performing genotype tests.
  4. A list of the types of samples that will be tested.
  5. The standard operating procedure for each test to be used, including methods, materials, equipment, and other relevant information.
  6. A list of the names of individuals performing specific tests and a detailed state of each individual?s qualifications.
  7. A detailed description of the procedures to satisfy the recordkeeping requirements of the Scrapie Eradication Program.
  8. A description of the specific procedures for reporting test results.
  9. The laboratory quality assurance manual.
  10. A statement authorizing APHIS to inspect the laboratory without notice during normal business hours. Such an inspection may include, but is not limited to, review and copying of records, observation of tests being conducted, and interviewing of personnel.

Following review of the application package for completeness, each laboratory is required to complete a preliminary test panel of samples to demonstrate basic technical competency for the required tests. NVSL then schedules and conducts a site visit to meet laboratory personnel, observe laboratory operations, inspect facilities and evaluate testing and laboratory protocols. Laboratory that successfully passes this site visit is then sent a second proficiency test panel to demonstrate a statistically high level of accuracy in conducting the genotyping tests. Following successful completion of the final proficiency panel the laboratory is given written notification of APHIS approval to conduct official scrapie genotype testing.

If you have any questions or are a representative of a laboratory that would like to be considered for approval to participate in the genotyping of sheep for the Scrapie Eradication Program, please contact Diane.L.Sutton@aphis.usda.gov.

Producers

Accredited Veterinarians

 

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Last Modified: July 27, 2011