Hybrid proteins CFP10 and ESAT6. A path from developing a molecule to population screening for TB infection
The review presents the history of the creation and mass production of Diaskintest® - a drug for mass screening of the population to detect a tuberculosis infection. The molecule contains two proteins ESAT6 and CFP10 that are only found in virulent Mycobacterium tuberculosis and are absent in the M. bovis BCG vaccine strain. The prognostic value of the drug is determined by the fact that these proteins are secreted by dividing Mycobacterium tuberculosis only, and not by that in a dormant state. Such a genetically engineered product required the creation of high-tech manufacturing facilities for mass production of the drug that would meet the needs of the entire country, which was done in the shortest possible time. This diagnosticum is intended for intracutaneous administration and its administration technique is similar to the Mantoux test, which made the test available for mass use. In preclinical studies, the skin test using Diaskintest® has proved its safety, high specificity and sensitivity. Clinical studies the results of which have been confirmed by broad clinical practice, as well as post-marketing surveillance demonstrated that the test has high specificity, sensitivity, and prognostic value. Mass screening of the child and adolescent population resulted in a sharp decrease in morbidity and an improvement in the structure of clinical forms in patients. Using the test in risk groups in adults makes it possible to identify persons with tuberculosis and those in need of preventive treatment. The Diaskintest® test has proven its effectiveness in clinical practice when used in primary health care.