Product Details:
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Delivery: | Within 48 Hours | Packaging Specifications: | 8 X 12 Strips, 96 Wells |
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Country Of Origin: | China,BeiJing | Detection Limit: | 18 Months |
Storage: | 2-8℃ | Specimen: | Whole Blood |
Assification: | Class1 | Product Type: | Elisa Test Kit |
Product Name: | TB-IGRA Elisa Test Kit | Package: | Carton/Box |
TB-IGRA is an in vitro diagnostic test that detects cell-mediated immune responses to Mycobacterium tuberculosis (MTB) infection by measuring interferon-gamma (IFN-γ) released by sensitized T cells upon stimulation with MTB-specific antigens (e.g., ESAT-6, CFP-10, and TB7.7).
Product details | Description |
Delivery | Within 48 hours |
Packaging Specifications | 8 x 12 strips, 96 wells |
Country Of Origin | China |
Manufacturer | 18 months |
Preservation method | 2℃-8℃ |
Specimen | Whole blood |
Assification | class1 |
Type | Elisa Test Kit |
High Specificity:
Uses MTB-specific antigens (absent in BCG and most non-tuberculous mycobacteria), minimizing false positives.
High Sensitivity:
Detects both active TB and latent TB infection (LTBI) with superior accuracy compared to tuberculin skin test (TST).
Quantitative/Qualitative Results:
Output varies by platform (e.g., spot counts in ELISPOT assays or IFN-γ concentration in ELISA).
Rapid Turnaround: Results typically available within 24–48 hours.
Sample Type: Fresh peripheral whole blood (heparinized).
Volume: Usually 1–3 mL per test (varies by kit manufacturer).
Storage: Process within 8–32 hours (depending on kit specifications).
Stimulation: Incubate blood with MTB antigens and controls (negative/mitogen control).
IFN-γ Detection:
ELISPOT-based (e.g., T-SPOT.TB): Count IFN-γ-secreting T cells as spots.
ELISA-based (e.g., QuantiFERON-TB Gold): Measure IFN-γ concentration via immunoassay.
Interpretation:
Results compared to cutoff values (varies by assay).
Indeterminate results may require retesting.
Sensitivity: >90% for active TB, ~80% for LTBI.
Specificity: >95% (unaffected by BCG vaccination).
Cross-reactivity: Minimal with non-tuberculous mycobacteria (NTM).
Screening for LTBI in high-risk groups (e.g., HIV+, immunosuppressed patients, close contacts).
Supplemental test for active TB diagnosis (must correlate with clinical symptoms and other tests).
No cross-reactivity with BCG.
Single-visit testing (no return for reading).
Objective, lab-based results.
Cannot distinguish active TB from LTBI.
Requires specialized lab equipment.
Higher cost than TST.
Potential false negatives in immunocompromised patients.
T-SPOT.TB (Oxford Immunotec): ELISPOT-based.
QuantiFERON-TB Gold Plus (Qiagen): ELISA-based.
Approved by FDA/CE/WHO for TB infection screening.
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
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
Contact Person: Mr. Steven
Tel: +8618600464506