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Federal regulatory practice issues: Vaccines

Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts
View government document (PDF, 30Kb)

Action

The Center for Veterinary Biologics (CVB) is providing guidance to interested parties for relating the response obtained in an ELISA immunodiagnostic kit to a titer.

Response

The AVMA supports regulatory guidance that helps to establish a clear basis for the clinical and diagnostic interpretation of reported sample-to-sample (S/P) ratios.

View AVMA response to USDA (PDF)
Status
AVMA responded on November 25, 2008
 


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