A New Model to Calibrate a Reference Standard for Bovine Tuberculin Purified Protein Derivative in the Target Species.

ABSTRACT: Since 1986, use of a Bovine International Standard (BIS) for bovine tuberculin has been required to ensure national and international uniformity regarding the potency designation of bovine tuberculin Purified Protein Derivative (PPDb) preparations produced by multiple manufacturers. The BIS is the unique golden standard in the guinea pig potency assay, representing 100% potency, where potencies of production batches are calculated as relative potencies in comparison with the potency of the BIS which was set at 32,500 international Unit (IU) per mg. The stock supply and lifetime of the BIS is limited.The aim of this study was to develop a model to determine the potency of a newly produced in-house Reference Standard (RS) for PPDb with great accuracy in the target species (cattle) and to pro

SUBMITTER: Frankena K 

PROVIDER: S-EPMC6178890 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature