Approval of diagnostic test kits not licensed by the Service.

CFR · 2024-01-01 · US · Title 9

(a) Diagnostic test kits that are not licensed by the Service (e.g., bacteriological culturing kits) may be approved through the following procedure: (1) The sensitivity of the kit will be evaluated in at least three NPIP authorized laboratories by testing known positive samples, as determined by the official NPIP procedures found in the NPIP Program Standards or through other procedures approved by the Administrator. Field samples, for which the presence or absence of the target organism or analyte has been determined by the current NPIP test, are the preferred samples and should be used when possible. Samples from a variety of field cases representing a range of low, medium, and high analyte concentrations should be used. In some cases it may be necessary to utilize samples from experimentally infected animals. Spiked samples (clinical sample matrix with a known amount of pure culture added) should only be used in the event that no other sample types are available. When the use of spiked samples may be necessary, prior approval from the NPIP Technical Committee is required. Pure cultures should never be used. Additionally, laboratories should be selected for their experience with testing for the target organism or analyte with the current NPIP approved test. ( (2) The specificity of the kit will be evaluated in at least three NPIP authorized laboratories by testing known negative samples, as determined by tests conducted in accordance with the NPIP Program Standards or othe

official document · source cfr-2024 · id 9:§ 147.54