Regulatory Brief

 Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts


Formal title: Draft Number 352 - Conversion Formulas for S/P Ratio to Titer in Diagnostic Test Kit Inserts


Brief Description:

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.

AVMA 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.

Background Documents:

View AVMA response to USDA (PDF)

 

Status:

 AVMA responded on November 25, 2008