Interferon-gamma Release Assay for Mycobacterium tuberculosis,IGRA - TB Elisa kit

ELISA Components

In Vitro Diagnostic Use Only
This kit contains reagents sufficient for testing of maximum of 28 specimens in a test run.

1. INTENDED USE

This kit is an enzyme-linked immunosorbent assay for quantitative detection of Interferon Gamma (IFN-γ) that responds to in-vitro stimulation by Mycobacterium tuberculosis antigens in fresh human whole blood. It is intended for use as an aid in the diagnosis of tuberculosis (TB) infection.

2. PRINCIPLE OF THE TEST
This kit uses the principle of IGRA combined with enzyme linked immunosorbent assay (ELISA) to
measure specific antigen mediated immune response strength. The antigens selected for stimulation is
specific fragments that pathogenic Mycobacterium tuberculosis have, but BCG vaccine and other
Mycobacterium do not have. The patients infected with Mycobacterium tuberculosis have specific T
lymphocytes which can identify these antigens and T lymphocytes will be stimulated to proliferate and
release cytokines such as IFN-γ. This kit uses ELISA method for quantitative detection the specific IFN-γ
released by cells to determine Mycobacterium tuberculosis infection.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world