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Standardisation

Standardisation

 

Scientists in NIBSC are invited by WHO as Temporary Advisers for the consultation on standardisation and evaluation of BCG vaccines and form the core part of the drafting group for the revision of the current recommendations to assure the quality, safety and efficacy of BCG vaccines. NIBSC also has contributed to the European Pharmacoepoeia monograph for BCG vaccine and BCG for immunotherapy.

 

The 1st International Reference Preparation for BCG vaccine is no longer in use. Three reference reagents for BCG vaccine of different sub-strains (Danish 1331, Russian BCG-I, Tokyo 172-1) were evaluated in international collaborative studies. They have been adopted by WHO ECBS in Oct 2009 and are now available for distribution.

 

The following standards and reference reagents are available in the NIBSC catalogue:

 

Description

Code

The 1st WHO Reference Reagent for BCG vaccine of Danish 1331 sub-strain

07/270

The 1st WHO Reference Reagent for BCG vaccine of Tokyo 172-1 sub-strain

07/272

The 1st WHO Reference Reagent for BCG vaccine of Russian BCG-I sub-strain

07/274

The 1st International Standard for Purified Protein Derivative (PPD) of Mycobacterium tuberculosis

PPDT

WHO International Standard for Purified Protein Derivative (PPD) of Mycobacterium bovis tuberculin

PPD BOV

WHO International Standard for Purified Protein Derivative (PPD) of Mycobacterium avium tuberculin

PPDA

The 3rd International Standard for Old Tuberculin

TU