QuantiFERON-TB Gold Plus (QFT-Plus)
For use as an aid in the detection of Mycobacterium tuberculosis (TB) infection
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.
The QuantiFERON-TB Gold Plus (QFT-Plus) is intended for in vitro diagnostic use in Europe. 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. ReferenceQuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 1083163 Rev. 02. February 2015.
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
QFT-Plus uses a peptide cocktail simulating ESAT-6 and CFP-10 proteins to stimulate cells in heparinized whole blood. Detection of IFNγ by ELISA is used to identify in vitro responses to these peptide antigens, which are associated with M. tuberculosis infection.
Procedure
The QFT-Plus test is a straightforward laboratory TB blood test that involves the following steps:
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:
Software
Analysis software for QuantiFERON-TB Gold Plus is available at www.QuantiFERON.com.
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