Program approval of tests for scrapie.

CFR · 2024-01-01 · US · Title 9

(a) The Administrator may approve new tests or test methods for the diagnosis of scrapie conducted on live or dead animals for use in the Scrapie Eradication Program and/or the Scrapie Free Flock Certification Program. The Administrator will base the approval or disapproval of a test on the evaluation by APHIS and, when appropriate, outside scientists, of: (1) A standardized test protocol that must include a description of the test, a description of the reagents, materials, and equipment used for the test, the test methodology, and any control or quality assurance procedures; (2) Data to support repeatability, that is, the ability to reproduce the same result repeatedly on a given sample; (3) Data to support reproducibility, that is, data to show that similar results can be produced when the test is run at other laboratories; (4) Data to support the diagnostic and in the case of assays the analytical sensitivity and specificity of the test; and (5) Any other data or information requested by the Administrator to determine the suitability of the test for program use. This may include but is not limited to past performance, cost of test materials and equipment, ease of test performance, generation of waste, and potential use of existing equipment. (b) To be approved for program use, a scrapie test must be able to be readily and successfully performed at the National Veterinary Services Laboratories. (c) The test must have a reliable, timely, and cost effective method of proficie

official document · source cfr-2024 · id 9:§ 54.10