Products
QuantiFERON-TB Gold Plus is an indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations. Reference QuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 1083163 Rev. 02. February 2015.
The QuantiFERON-TB Gold Plus (QFT-Plus) is intended for in vitro diagnostic use in Europe.
Features
- Higher sensitivity at >95%
- Highest specificity of any test for tuberculosis infection
- Innovative CD8+ T-cell technology
- Robust and reliable results
- Improvements in TB test formulation and manufacturing
Product Details
QuantiFERON-TB Gold Plus detects interferon γ (IFNγ) response by enzyme-linked immunosorbent assay (ELISA) to provide the most accurate TB test kit for TB infection.
Performance
QFT-Plus is an improved version of the current QuantiFERON-TB Gold test, using the same test principle, procedure and reliable technology. This TB blood test is highly accurate, with sensitivity of 95.3% and specificity of 97.6%.
QFT-Plus is an IFNγ release assay, commonly known as an IGRA, and measures the cell-mediated immune response to specific TB antigens in whole blood. Patients may be tested in a single patient visit, with objective results.
Additional clinical value comes from the exclusive TB-specific antigens that elicit CD4+ and CD8+ T-cell responses. This new test format, combined with improvements in tuberculosis test formulation and manufacturing, means more robust and reliable assay performance.
Principle
QuantiFERON is a powerful Premolecular diagnostic technology that delivers results with high sensitivity, enabling the detection of M. tuberculosis infection even in early or latent stages. The QFT-Plus test employs a peptide cocktail simulating ESAT-6 and CFP-10 proteins to stimulate cells in heparinized whole blood. Detection of IFN-γ by ELISA is used to identify in vitro responses to these peptide antigens, which are associated with M. tuberculosis infection. Premolecular Diagnostics that employ QuantiFERON technology, like QFT-Plus, are able to detect infection at an earlier stage than is possible with DNA- and RNA-based molecular diagnostics.
Procedure
The QFT-Plus test is a straightforward laboratory TB blood test that involves the following steps:
- Collect whole blood in a standard blood collection tube, or specialized QFT-Plus Blood Collection Tubes.
- Incubate for 16 to 24 hours at 37°C.
- Detect released IFNγ in harvested plasma by ELISA.
- Analyze results using QFT-Plus Analysis Software.
QFT-Plus has 4 blood collection tubes: Nil, TB1, TB2, and Mitogen. Collect 1 ml of whole blood into each tube.
Applications
QFT-Plus can be used in many clinical and public health settings, including screening for healthcare workers, children at high-risk of exposure to TB, immigrants, military personnel, those in correctional facilities, and homeless individuals.
QFT-Plus can also be used in at-risk populations, such as:
QFT-Plus can also be used in at-risk populations, such as:
- People taking certain medications (e.g., TNF alpha inhibitors)
- Patients with weakened immune systems
- Elderly patients
Resources
Kit Handbooks (2)
Package Insert (1)
Safety Data Sheets (1)
Software User Guides (1)
Analysis Software (1)
Certificates of Analysis (1)