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TigraTest®TB

TigraTest®TB

TigraTest®TB is the first completely Russian test based on the ELISPOT platform for diagnosing tuberculosis infection in vitro at a single visit to a specialist.

Description

It belongs to the IGRA group of tests (Interferon gamma release assay).

The ELISPOT technology makes it possible to detect cells (T-lymphocytes) in the blood that specifically respond to the ESAT-6 and CFP-10 antigens of the Mycobacterium tuberculosis complex and has proven high accuracy in various groups of patients both in Russia and abroad. ELISPOT technology is much more efficient than ELISA technology.

TigraTest®TB is highly informative in the diagnosis of TI with specificity and sensitivity of 100%.

TigraTest®TB can be used at any age for the diagnosis of TI, including for screening for tuberculosis in individuals at high risk for the development of tuberculosis infection and differential diagnosis of tuberculosis infection from post-vaccination allergy as a result of BCG vaccination (Mycobacterium bovis BCG).1.

ELISPOT platform based tests have proven advantages over other tests in people with immunodeficiency diseases and conditions, and therefore are preferable for examining people living with HIV infection, as well as for screening for TI in patients with any autoimmune diseases, including initiation and monitoring of biologic therapy1.

The IGRA test based on the ELISPOT technique can be used for early detection of TI in children if parents refuse to perform skin tests.2

IGRA tests are included in the regulatory documents of the Russian Ministry of Health and the recommendations of the World Health Organization for the diagnosis of latent TI and active tuberculosis of pulmonary and extrapulmonary localizations3.

1 Clinical guidelines “Latent tuberculosis infection”, Moscow, 2024

2 Resolution of the Chief State Sanitary Doctor of the Russian Federation No. 4 dated January 28, 2021 “On approval of sanitary rules and norms SanPiN 3.3686-21 “Sanitary and epidemiological requirements for the prevention of infectious diseases””

3 WHO operational handbook on tuberculosis. Module 3: diagnosis. Tests for tuberculosis infection. Geneva: World Health Organization; 2022