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.
QuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 1083163 Rev. 02. February 2015.
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.
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.
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.
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:
People taking certain medications (e.g., TNF alpha inhibitors)