LIAISON QuantiFERON -TB Gold Plus Solution

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Tuberculosis LIAISON QuantiFERON -TB Gold Plus Solution Let TB testing flow FOR OUTSIDE THE US AND CANADA ONLY

LIAISON QuantiFERON -TB Gold Plus Solution A new fully automated CLIA assay to aid in the diagnosis of TB infection Patient samples are collected in four QuantiFERON -TB Gold Plus (QFT -Plus) Blood Collection Tubes (Nil, TB1, TB2 and Mitogen) The four samples are incubated at 37 C for 16-24 hours to stimulate the T cells of the Anti-TB immunized patient to produce interferon-gamma TEST PRINCIPLE Interferon-gamma quantitation is performed on the LIAISON XL automated chemiluminescence system The four individual results are combined in a single qualitative patient report to assess the immunization status versus Mycobacterium tuberculosis QFT -Plus can detect both active and Latent TB infection Patients with positive QFT -Plus results should be furtherly investigated and treated accordingly

LIAISON QuantiFERON -TB Gold Plus Solution Unmatched clinical value INNOVATIVE CD8 + T CELLS TECHNOLOGY LIAISON QFT -Plus is designed to work with QIAGEN Quantiferon -TB Gold Plus Blood Collection Tubes. These tubes employ innovative tuberculosis-specific antigens that elicit both CD8+ and CD4+ T cell responses enabling a more accurate assessment of cell-mediated immune response to TB infection (1) CD8 + T cells have been shown to play an important role in Mycobacterium tuberculosis immunity (2 4). LIAISON QFT -Plus measures the cell-mediated immune response to tuberculosis infection from both CD4 + and CD8 + T cells. QFT -Plus has a higher sensivity for TB detection in HIV coinfected patients who are at major risk of mortality for TB QuantiFERON -TB Gold Plus Blood Collection Tubes For orders and information contact your QIagen representative or visit www.qiagen.com Nil - Negative Control Adjusts for background IFN-γ TB1 - Primarily detects CD4 + T cell response TB2 - Optimized for detection of CD4 + and CD8 + T cell responses Mitogen - Positive Control Low response may indicate inability to generate IFN-γ 1. World Health Organization. (2017) Global tuberculosis report 2017. www.who.int/tb/publications/global_report/en/ 2. Turner, J. et al. (1996) Immunology 87, 339 3. Brookes, R.H. et al. (2003) Eur. J. Immunol. 33, 3293. 4. Stenger, S. et al. (1998) Science 282, 121.

LIAISON QuantiFERON -TB Gold Plus Solution Unparalleled workflow COMPLETE TRACEABILITY AND MAXIMUM FLEXIBILITY Primary QFT -Plus Blood Collection Tubes can be loaded directly on the LIAISON XL in random order As an alternative solution, single Li-Hep tubes can be processed by the lab within 16 hours from collection QFT -Plus assay can be performed in random access routine in hostquery mode on LIAISON XL or LIAISON XL LAS connected to lab automation solutions Minimum hands-on time allows maximum lab convenience LIAISON QuantiFERON software (LQS) allows check-in, barcode duplicaton, automatic interpretation of results, repetitions and retesting Patient results are sent directly to the LIS

On-s 16 DIRECT COLLECTION IN QFT-PLUS TUBES 17-25 C Mix by shaking 10 times at 17-25 C Tran within 17-25 C Mix by inverting at 17-25 C COLLECTION IN ONE SINGLE LI-HEP TUBE

ite incubation -24h at 37 +/- 1 C Transfer to the lab within 3 days at 4-27 C sfer to the lab 16 hours at 17-27 C Incubation in the lab 16-24h at 37 +/- 1 C Centrifugation Split into 4 tubes Transfer to the lab within 16 hours at 17-27 C Incubation in the lab 16-24h at 37 +/- 1 C

RESULTS INTERPRETATION ANALYTICS LIS Loading samples Host-query Combined Patient Report LIAISON XL QFT worklist 4 read-outs LQS Loading reagents and consumables

LIAISON QuantiFERON -TB Gold Plus Solution Let TB testing flow LIAISON QuantiFERON -TB Gold Plus Kit format Conjugate vials Open kit stability Conjugate reconstituted stability Calibrators reconstituted stability Calibration stability Time to first patient result (4 tubes) Throughput Code 311010 200 tests/50 patient results 2x200 test/each 28 days 14 days each vial 28 days 28 days 46 min up to 25 patient results/hour LIAISON Control QuantiFERON -TB Gold Plus Kit format Control reconstituted stability Code 311011 2 levels x 2 vials (up to 40 runs) 28 days QuantiFERON, QuantiFERON Plus, QFT, QFT -Plus and QuantiFERON -TB Gold Plus are registered trademarks of QIAGEN LIAISON is a registered trademark of DiaSorin AVAILABLE ONLY ON M0870004401 09/18 Product availability subject to required regulatory approval DiaSorin S.p.A. Via Crescentino 13040 Saluggia (VC) - Italy Tel. +39.0161.487526 Fax: +39.0161.487670 www.diasorin.com E-mail: info@diasorin.it