Diseases & Solutions > Diagnostic Solutions > Tuberculosis > Tuberculin PPD

Tuberculin PPDs are purified protein derivatives of tuberculin that are applied in the diagnosis of bovine tuberculosis. The Tuberculin PPD Kit contains bovine (3000 IU/dose) and avian (2500 IU/dose) tuberculin PPD matched for the single intradermal comparative tuberculin (SICCT) test. Prionics also offers separate Bovine and Avian Tuberculin PPD products. The Tuberculin PPD products from Prionics are manufactured under GMP conditions, as laid down in EC directive 91/412/EC for Veterinary Medicinal Products. The products are tested according to the European Pharmacopoeia monographs [0536] and [0535]. The potency of the Tuberculin PPDs is determined in the Guinea pig potency test as defined in the EC directive 64/432/EC.
With the Tuberculin PPD production in place since 1949, the Lelystad tuberculin unit, now part of Prionics, has a long tradition of tuberculin PPD manufacturing. The Tuberculin PPD batch produced in 1986 in Lelystad is being used as the international reference standard for bovine tuberculin PPD by the World Health Organization (WHO) and the European Commission (EC). At its locations in Lelystad, Prionics maintains one of the largest productions of Tuberculin PPDs in the world. An important advantage of the Tuberculin PPD products from Prionics is that they can be transported outside of the cold chain, reducing transport costs and considerably increasing transportation flexibility.

Skin test
Bovine and Avian Tuberculin PPDs are administered intradermally and are thus in vivo diagnostica. In TB cattle, injection of bovine tuberculin PPD results in an immunological response at the site of injection. This is referred to as the Delayed Type Hypersensitivity (DTH) reaction and is observed as swelling and local inflammation of the skin (lesion). The thickness of the skin is measured with callipers 72 hours following injection. Avian tuberculin PPD is used to control for unspecific reactions.

The Bovine and Avian Tuberculin PPDs were used to eradicate bovine TB in the Netherlands in the late 1950's. The products contribute to the reduction of bovine TB in Ireland since 1980 and the UK since 2005. In 2010, Prionics received marketing authorization for the Tuberculin PPD Kit (Bovine and Avian Tuberculin PPD) from the UK, Ireland and the Netherlands. The Tuberculin PPD Kit successfully passed the extensive decentralized approval procedure as laid down in EC Directive 2001/82/EC and is now registered in these three EU countries for application in the SICCT test for the diagnosis of bovine tuberculosis. The Tuberculin PPD Kit is approved for TB diagnosis in cattle starting from zero days of age. It can thus also be used in young calves, leading to early detection of TB in cattle herds.

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