Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Detection Kit TB-IGRA Elisa kit

Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Detection Kit(ELISA)

Read the package insert carefully and completely before performing the assay. Follow the instructions and do not modify them. Only by strict adherence to these instructions, the erroneous results can be avoided and the optimal performance of this kit.

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. SUMMARY

Tuberculosis is a communicable disease caused by infection with M.tuberculosis (MTB)complex organisms (M. tuberculosis, M. bovis, M. africanum), which typically spread to new hosts via airborne droplet nuclei from patients with respiratory tuberculosis disease. It is one of the most important health threatening problems worldwide. The World Health Organization estimates that one third of the world’s population is infected with M.tuberculosis. Each person carrying latent TB infection (LTBI) has approximately a 10% chance of progressing to active disease. Interferon Gamma Release Assay (IGRA) measure a person’s immune reactivity to M.tuberculosis. T lymphocytes from most persons that have been infected with M.tuberculosis will release IFN-γ when mixed with special antigens derived from M.tuberculosis. IGRA is whole-blood test that can aid in diagnosing Mycobacterium tuberculosis infection, including both latent tuberculosis infection (LTBI) and tuberculosis (TB) disease.

3. COMPONENTS

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

1. Negative Control (Grey lid) 28tests

2. TB Antigen, lyophilised (Purple lid) 28tests

3. TB Antigen Diluent(Purple lid) 0.9mL

4. Positive Control (Red lid) 28tests ELISA Components 1. Microplate Strips 96 well 2. Human IFN-γ Standard, lyophilised (Blue lid) 2 x vial 3. Diluent 1 x 40mL 4. Biotin Labeled Antibody (Yellow cap) 1 x 6mL

5. Enzyme Conjugate 100X Concentrate (Brown bottle)1 x 130μL

6. Wash Buffer 10X Concentrate 1 x 40mL

7. Chromogen Solution A 1 x 6mL

8. Chromogen Solution B 1 x 6mL 9. Stopping Solution 1 x 6m

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