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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.
In Vitro Diagnostic Use Only
This kit contains reagents sufficient for testing of maximum of 28 specimens in a test run.
1. Negative Control (Grey lid) 28tests
2. TB Antigen, lyophilized (Purple lid) 28tests
3. TB Antigen Diluent (Purple lid) 0.9mL
4. Positive Control (Red lid) 28tests
1. Microplate Strips 12x 8 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 6mL
MATERIALS REQUIRED BUT NOT PROVIDED
Freshly distilled or deionized water, disposable gloves and timer, appropriate waste containers for potentially contaminated materials, dispensing system and/or pipette, disposable pipette tips, absorbent tissue or clean towel, Water Bath(37±1°C), Plate Reader(dual wavelength 450/600~650nm), microwell aspiration/wash system.
SPECIMEN COLLECTION, TRANSPORTATION AND STORAGE
1. Fresh whole blood samples are required for this assay. Whole blood samples must be collected in endotoxin-free blood collection tubes with heparin as anticoagulant (BD Heparin Tubes are highly recommended).
2. Hemolyzed samples or samples containing suspended fibrin or aggregates must not be used as they could give erroneous results in the assay.
3. The whole blood samples should be respectively dispensed into “N”, “T” and “P” culture tubes in turn within 3 hours after collected, and then place the culture tubes in incubator at 37°C to culture.
4. Do not shaking hardly, ice-bath or freeze samples.
5. After culture, the plasma is separated from the whole blood samples by centrifugation. The plasma separated can be stored at 2-8°C for 1 week. For long-term storage, should be frozen at -20°C or lower, multiple freeze-thaw cycles should be avoided.
6. For shipment, samples should be packaged and labeled in accordance with the existing local and international regulations for transport of clinical samples and ethological agents.
STORAGE AND STABILITY
The components of the kit remain stable 1 year when stored between 2-8°C,
Once Stimulation Components are opened, the kit remain stable for 1 week at 2-8℃, 3 weeks at less then -20℃.
Once ELISA Components are opened, the kit remain stable for 3 weeks at 2-8℃.
The dissolved Human IFN-γ Standard should be ready for use.
The dissolved TB Antigen remain stable for 1 week at 2-8℃, 3 weeks at less then -20℃.