QuantiFERON-TB Gold Plus (QFT-Plus)For use as an aid in the detection of Mycobacterium tuberculosis (TB) infection
QuantiFERON-TB Gold Plus is an indirect test for TB infection.
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QFT-Plus is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection. QFT-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. QFT-Plus Package Inserts, available in multiple languages, as well as up-to-date licensing information and product-specific disclaimers can be found at www.QuantiFERON.com.
ReferenceQuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 1095849 Rev. 02. August 2017.Product Details
Performance
QuantiFERON-TB Gold Plus (QFT-Plus) uses the same test principle, procedure and reliable technology as the QuantiFERON-TB Gold Test. This TB blood test is highly accurate, with sensitivity of 94% and specificity of 97%. Moreover, QFT-Plus is now optimized with innovative CD8 T cell technology, providing a more comprehensive view of the immune response to TB infection
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. The test employs standard phlebotomy procedures using whole blood to make sample collection easy and fast. Sample incubation can occur on-site or at the testing laboratory, providing your practice with complete flexibility and convenience. Patients may be tested in a single patient visit, with objective results.
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:
Refer to the Package Insert for detailed instructions for use.
Applications
QFT-Plus can be used in many clinical and public health settings, including screening for healthcare workers, immigrants, military personnel, those in correctional facilities and homeless individuals.
Software
Analysis software for QuantiFERON-TB Gold Plus is available at www.QuantiFERON.com.
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