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TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay

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TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay

TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay
TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay

Large Image :  TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay

Product Details:
Place of Origin: CHINA
Brand Name: BIOVANTION
Certification: ISO 13485
Model Number: TY0031
Payment & Shipping Terms:
Minimum Order Quantity: 1000 Box
Price: discussible
Packaging Details: carton/box
Delivery Time: 2-7 days
Payment Terms: L/C, D/A, D/P, T/T, Western Union, MoneyGram
Supply Ability: 100000 Box/carton

TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay

Description
Delivery: Within 48 Hours Packaging Specifications: 8 X 12 Strips, 96 Wells
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 ELISA TEST KIT

 

 

1. Principle

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

TB-IGRA ELISA Test Kit Tuberculosis Interferon-Gamma Release Assay 0

 

2. Key Features

  • 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.

3. Sample Requirements

  • 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).

4. Assay Procedure

  1. Stimulation: Incubate blood with MTB antigens and controls (negative/mitogen control).

  2. 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.

  3. Interpretation:

    • Results compared to cutoff values (varies by assay).

    • Indeterminate results may require retesting.

5. Performance Metrics

  • Sensitivity: >90% for active TB, ~80% for LTBI.

  • Specificity: >95% (unaffected by BCG vaccination).

  • Cross-reactivity: Minimal with non-tuberculous mycobacteria (NTM).

6. Indications

  • 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).

7. Advantages Over TST

  • No cross-reactivity with BCG.

  • Single-visit testing (no return for reading).

  • Objective, lab-based results.

8. Limitations

  • Cannot distinguish active TB from LTBI.

  • Requires specialized lab equipment.

  • Higher cost than TST.

  • Potential false negatives in immunocompromised patients.

9. Compatible Kits (Examples)

  • T-SPOT.TB (Oxford Immunotec): ELISPOT-based.

  • QuantiFERON-TB Gold Plus (Qiagen): ELISA-based.

10. Regulatory Status

  • 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

 

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

 

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.

 

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Contact Details
Biovantion Inc.

Contact Person: Mr. Steven

Tel: +8618600464506

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