TB-IGRA ELISA TEST KIT

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.

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.

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)

2. TB Antigen, lyophilized (Purple lid)

3. TB Antigen Diluent (Purple lid)

4. Positive Control (Red lid) 28tests 28tests 0.9mL 28tests

ELISA Components

1. Microplate Strips

2. Human IFN-γ Standard, lyophilised (Blue lid)

3. Diluent

4. Biotin Labeled Antibody (Yellow cap) 12x 8 well 2 x vial 1 x 40mL 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

8. Chromogen Solution B

9. Stopping Solution 1 x 6mL 1 x 6mL 1 x 6mL