· Test Principle ·

Interferon-γ release assays (IGRA) are specific tests used in the diagnosis of some infectious diseases, the most widespread application is for the diagnosis of Human Tuberculosis (TB). 

Interferon-γ (IFN-γ) release assays are based on the fact that T-lymphocytes will release IFN-γ when exposed to specific antigens. These tests were mostly developed for the field of tuberculosis diagnosis, but in theory, may be used in the diagnosis of other diseases which rely on cell-mediated immunity.

In addition to the diagnosis of Mycobacterium tuberculosis, IGRA tests have been developed for the diagnosis of Cytomegalovirus, Leishmaniasis and, recently, for the diagnosis linked to COVID-19.

This test detects the amount of IFN-γ produced by T-lymphocytes, in response to the stimulation of specific Antigens. For Mycobacterium tuberculosis testing,  ESAT-6 and CFP-10 antigens are used which are distinguishable from those present in BCG and most other non-tuberculous mycobacteria.

· Main Application: Mycobacterium tuberculosis infection (TB) ·

Human tuberculosis (TB) has become a global disease with its re-emergence in the Western countries in the last decades. According to WHO, more than 30% of the world’s population is estimated to be infected with the TB bacterium, Mycobacterium tuberculosis. TB is predominantly a disease of the respiratory tract but can also affect other organs. People who are suffering from active pulmonary tuberculosis are highly infectious. TB kills yearly about 2 million people.

T-lymphocytes from people infected with M. tuberculosis recognize specific mycobacterial antigens and provoke cytokine production, i.e. IFN-γ. The quantitative determination of IFN-γ is the basis of the Interferon-Gamma (IFN-γ) Release Assay (IGRA) and can be a useful tool for the diagnosis of both, active TB and latent TB.

IGRAs are widely used to determine IFN-γ-response of human Peripheral Blood Mononuclear Cells (PBMCs) to active- and latent tuberculosis by using recombinant antigens of M. tuberculosis. The WHO has endorsed IGRAs as the preferred test for the detection of latent TB Infection (LTBI) in BCG-vaccinated persons in low-burden TB countries.

· SkyLAB 752 Automation of IFN-γ testing ·

MACS srl, in cooperation with the main manufacturers of IGRA tests, developed, on the platform SkyLAB 752, a dedicated application for IGRA testing that allows the full automated process of the ELISA test, on a standard 96 wells microplate, for the detection of IFN-ƴ produced by T-lymphocytes.

A dedicated Management Software is able to manage the data obtained from the IGRA testing and to elaborate a final report for the patient.

The experience acquired by the R&D team of MACS, combined with the flexibility and easy to use of the machine, make our technical proposal of automation absolutely efficient and competitive.

The SkyLAB 752 IGRA testing solution allows laboratory operators to benefit from an automatic and effective platform for less manipulation and improved time to results.

· VitroCert ·