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.
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.
The QuantiFERON-TB Gold Plus (QFT-Plus) is intended for in vitro diagnostic use in Europe.
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.
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.
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.
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:
Analysis software for QuantiFERON-TB Gold Plus is available at www.QuantiFERON.com.
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