Биопрепараты: Профилактика, диагностика, лечение (Feb 2018)
Comparison of efficacy of Diaskintest<sup>®</sup>, a skin test with a recombinant tuberculosis allergen, used for 10 years and Mantoux tuberculin sensitivity test used for 110 years
Abstract
The article compares results reported in national and foreign literature concerning tuberculosis detection by various in vivo (skin tests such as the Mantoux test and Diaskintest® (a skin test with a recombinant tuberculosis allergen)) and in vitro methods (IGRA tests). A positive reaction to the Mantoux test, which has been used for over 100 years as part of mass immunization against tuberculosis, can be indicative of both earlier vaccination and of infection caused by virulent Mycobacteria tuberculosis. Given the mass scale of BCG vaccination, the positive reaction to tuberculin loses its predictive value for assessing the risk of tuberculosis. Diaskintest®, a recombinant tuberculosis allergen, was developed in Russia in early 2000s, authorized in 2008 and has been used in the national healthcare system since 2009. This is a recombinant fusion protein ESAT6-CFP10 produced using Echerichia coli BL21(DE3)/pCFP-ESAT. Differential diagnosis between post vaccination (BCG) and bacterial allergic reactions using Diaskintest® demonstrated high efficacy of the product - detection of tuberculosis in people with a positive reaction to the test was much higher than that of the Mantoux test. Both Diaskintest® and IGRA tests usually do not produce false negative reactions. Therefore no additional examination of non-infected people is needed, and the preventive therapy is given only to those people who have a high risk of developing tuberculosis.
