Evaluation and adoption of a new international reference standard for bovine tuberculin

摘要

Introduction Bovine tuberculin puri?ed protein derivative (Bo-PPD) is an essential tool in the diagnosis of bovine tuberculosis, a zoonotic infection that remains of concern in many countries of the world. The main use of Bo-PPD is as a skin-test antigen for intradermal inoculation to detect delayed-type hypersensitivity reactions to Mycobacterium bovis infections. It is also used as antigen for in vitro tests to detect cellular immunity, such as the gamma interferon test. The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (the Terrestrial Manual) describes diagnostic procedures for bovine tuberculosis, as well as the method of manufacture of Bo-PPD. The latter requires that the potency of the product is determined by comparison with a standard reference preparation. Similar requirements are found in national and regional standards, such as Title 9 of the Code of Federal Regulations (9-CFR) in the USA and the European Pharmacopoeia.