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Potential for Additional Clinical Insights with QFT®-Plus Based on Research Studies

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Potential for Additional Clinical Insights with QFT®-Plus Based on Research Studies Potential for additional clinical insights with QFT®-Plus based on research studies TB-specific CD8 T cells that produce IFN-γ may also provide additional IFN-ᵧ (IU/ml) 7 clinical insights. CD8 T cells have been: 6 5 • More frequently detected in patients with active TB 4 compared to latent TB infection (1, 2) 3 2 • Associated with recent exposure to TB (3) 1 0 • Detectable in active TB patients with HIV co-infection and -1 in young children (4–6) -2 -3 • Observed to decline when patients are exposed to Low Risk Mixed Risk Active TB tuberculosis therapies (7) Risk of MTB Infection Research indicates the potential for additional clinical information on the Figure 1. Observed difference between TB1 and TB2 values (nil subtracted), stratified by risk (8). CD8 T cell response to TB infection by subtracting the TB1 from TB2 tube values (Figure 1). In the 2016 Global Tuberculosis Report, The World Health Organization acknowledged the potential for additional clinical insights using QFT-Plus (9): “ Current IGRA assays primarily detect a CD4 T-cell response. However, a new generation assay, the QuantiFERON-TB Plus (QFT-Plus, QIAGEN, Hilden, Germany), has been developed to stimulate gamma interferon production by both CD4 and CD8 T-cells. First results indicate that the CD8 T-cell response may be able to identify people at greater risk of progression to active TB.” Sample to Insight QuantiFERON®-TB Gold Plus research publications Table 1. Peer reviewed publications using QFT-Plus Author Title Journal Reference BARCELLINI et al. First independent evaluation of QuantiFERON-TB Plus performance. Eur. Respir. J. 2016 HOFFMANN et al. Equal sensitivity of the new generation QuantiFERON-TB Gold plus in direct comparison with Clin. Microbiol. Infect. 2016 the previous test version QuantiFERON-TB Gold IT. BARCELLINI et al. First evaluation of QuantiFERON-TB Gold Plus performance in contact screening. Eur. Respir. J. 2016 GALLAGHER et al. Preliminary data on precision of QuantiFERON-TB Plus (QFT-Plus) performance. Eur. Respir. J. 2016 PETRUCCIOLI et al. First characterization of the CD4 and CD8 T-cell responses to QuantiFERON-TB Plus. J. Infect. 2016 YI et al. Evaluation of QuantiFERON-TB Gold Plus for Detection of Mycobacterium tuberculosis infection Sci. Rep. 2016 in Japan. MOON et al. Evaluation of QuantiFERON®-TB Gold-Plus in Healthcare Workers in a Low-Incidence Setting. J. Clin. Microbiol. 2017 KAMADA et al. QuantiFERON-TB® Gold Plus as a potential tuberculosis treatment monitoring tool. Eur. Respir. J. 2017 TELISINGHE et al. The sensitivity of the QuantiFERON-TB Gold Plus assay in Zambian adults with active Int. J. Tuberc. Lung Dis. 2017 tuberculosis. References: 1. Day, C.L. et al. (2011) Functional capacity of Mycobacterium tuberculosis-specific T cell responses in humans is associated with mycobacterial load. J. Immunol. 187, 2222. 2. Rozot, V. et al. (2013) Mycobacterium tuberculosis-specific CD8+ T cells are functionally and phenotypically different between latent infection and active disease. Eur. J. Immunol. 43, 1568. 3. Nikolova, M. et al. (2013) Antigen-specific CD4- and CD8-positive signatures in different phases of Mycobacterium tuberculosis infection. Diagn. Microbiol. Infect. Dis. 75, 277. 4. Barcellini, L. et al. (2016) First independent evaluation of QuantiFERON-TB Plus performance. Eur. Respir. J. 47, 1587. 5. Chicchio, T. et al. (2014) Polyfunctional T-cells and effector memory phenotype are associated with active TB in HIV-infected patients. J. Infect. 69, 533. 6. Lanicioni, C. et al. (2012) CD8+ T cells provide an immunologic signature of tuberculosis in young children. Am. J. Respir. Crit. Care Med. 185, 206. 7. Nvendak, M. et al. (2013) Mycobacterium tuberculosis Specific CD8+ T Cells Rapidly Decline with Antituberculosis Treatment. PLoS ONE. 8, e81564. 8. QuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 1095849 Rev. 01 June 2017. 9. World Health Organization. Global Tuberculosis Report 2016. WHO/HTM/TB/2016.13 2016. QFT-Plus is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection. It uses a peptide cocktail simulating ESAT-6 and CFP-10 proteins to stimulate cells in heparinized whole blood. Detection of interferon-γ (IFN-γ) by ELISA is used to identify in vitro responses to these peptide antigens that are associated with 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 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. Trademarks: QIAGEN®, Sample to Insight®, QuantiFERON®, QFT® (QIAGEN Group). Registered names, trademarks, etc., used in this document, even when not specifically marked as such, are not to be considered unprotected by law. PROM--11189-001 07/2017 1107786 © 2017 QIAGEN, all rights reserved. Ordering www.qiagen.com/shop | Technical Support support.qiagen.com | Website www.QuantiFERON.com 1107786 07/2017.
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