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Trusted IGRA Science, Simplified Workflow
LIAISON® QuantiFERON®-TB Gold Plus Solution
Tuberculosis
FOR THE US ONLY
LIAISON® QuantiFERON®-TB Gold Plus Solution
A new fully automated Interferon Gamma Release Assay (IGRA) using chemiluminescence to aid in the diagnosis of latent TB infection
1. Patient samples are collected in four QuantiFERON®-TB Gold Plus (QFT®-Plus) Blood Collection Tubes (Nil, TB1, TB2 and Mitogen)
2. The four samples are incubated at 37°C for 16-24 hours to stimulate patient T cells to produce interferon-gamma
3. Interferon-gamma detection is performed on the LIAISON® XL automated chemiluminescence system
4. The four individual results are combined in a single qualitative patient result which indicates the immune response to Mycobacterium tuberculosis
Patients with positive QFT®-Plus results should be further investigated and treated accordingly
TEST PRINCIPLE
CD8+ T cellshave 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.
LIAISON® QuantiFERON®-TB Gold Plus Solution
Unmatched clinical value
INNOVATIVE CD8+ T CELLS TECHNOLOGY
LIAISON® QuantiFERON®-TB Gold 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 latent TB infection(1)
1. World Health Organization. (2018) Global tuberculosis report 2018. https://www.who.int/tb/publications/global_report/tb18_ExecSum_web_4Oct18.pdf?ua=1
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.
5. QIAGEN QuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 1095849 Rev. 01 July 2018.
QFT®-Plusblood collection tubes are optimized with innovative tuberculosis-specific antigens that elicit both CD8+ and CD4+ T cell responses - enabling a more comprehensive assessment of cell-mediated immune response to TB infection5
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
QuantiFERON®-TB Gold Plus Blood Collection TubesFor orders and information contact your QIAGEN representative or visit www.qiagen.com
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 tube draws allow workflow flexibility of up to 53 hours from collection before processing in QFT®-Plus Blood Collection Tubes*
LIAISON® QuantiFERON®-TB Gold Plus assay can be performed in random access routine in host-query 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, optional) provides a plug and play option for check-in, barcode duplication, automatic interpretation of results, repetitions and retesting
Patient results are sent directly to the LIS
53
*For complete details see QuantiFERON®-TB Gold Plus IFU.
DIRECT COLLECTION IN QFT®-PLUS TUBES*
COLLECTION IN ONE SINGLE LI-HEP TUBE
17-25 °CMix by inverting
at 17-25 °C
17-25 °CMix by shaking 10 times
at 17-25 °C
On-site incubation16-24h at 37 +/- 1°C
Transfer to the lab
Aliquot into 4 QFT tubes
Transfer to the lab
DIRECT COLLECTION IN QFT®-PLUS TUBES*
COLLECTION IN ONE SINGLE LI-HEP TUBE
Incubation in the lab16-24h at 37 +/- 1°C
*For complete instructions on this process see QuantiFERON®-TB Gold Plus IFU.
On-site incubation16-24h at 37 +/- 1°C
Transfer to the labwithin 3 days at 4-27°C
Centrifugation
Incubation in the lab16-24h at 37 +/- 1°C
Transfer to the lab
@17-25 °C: allow up to 2 hours after aliquoting to incubation
@17-25 °C: aliquot within 12 hours of collection@2-8 °C: Refrigerate within 3 hours, hold at 2-8 °C
for up to 48 hours
ANALYTICS
RESULT INTERPRETATION
LIAISON® XL
Load samples
Load reagents and consumables
LQS OR MIDDLEWARE
4 read-outs
QFT® worklist
LIS DIRECT
OR
LIAISON® QuantiFERON®-TB Gold Plus Code 311020
Kit format 200 tests/50 patient results
Conjugate vials 2x200 tests
Open kit stability 28 days , stored at 2-8°C
Reconstituted conjugate stability 14 days each vial, stored at 2-8°C
Reconstituted calibrator stability 28 days , stored at 2-8°C
Calibration stability 28 days
Time to first patient result (4 tubes) 46 min
Throughput up to 25 patient results/hour
LIAISON® Control QuantiFERON®-TB Gold Plus Code 311021
Kit format 2 levels x 2 vials (up to 40 runs)
Reconstituted control stability 28 days, stored at 2-8°C
QIAGEN QuantiFERON®-TB Gold Plus Blood Collection Tubes
Dispenser pack of QFT®-Plus Blood Collection Tubes
25 packs per carton, each pack including: 1 Nil tube, 1 TB1 Antigen tube, 1 TB2 Antigen tube and 1 Mitogen tubes
Code 622433
QuantiFERON®-TB Gold Plus Blood Collection Tubes
200 QFT®-Plus Blood Collection Tubes (50 each: Nil, TB1, TB2, and Mitogen tubes)
Code 622536
QFT®-Plus Blood Collection Tubes, kit and controls available for purchase from QIAGEN. High Altitude tubes also available. Contact your
local sales representative or visit www.qiagen.com for more information.
For general inquiries call 1-800-328-1482 or visit www.diasorin.com
QuantiFERON®, QuantiFERON® Plus, QFT®, QFT®-Plus and QuantiFERON®-TB Gold Plus are registered trademarks of QIAGEN
LIAISON® is a registered trademark of DiaSorin
LIAISON® QuantiFERON®-TB Gold Plus Solution
Unmatched clinical value
AVAILABLE ONLY ON
QuantiFERON®-TB Gold Plus Blood Collection TubesFor orders and information contact your QIAGEN representative or visit www.qiagen.com
APM
1775
527
12
LIAISON® QuantiFERON®-TB Gold Plus Solution
Simplified Kit and Control Format
Product availability subject to required regulatory approval
DiaSorin Inc.1951 Northwestern Ave
Stillwater, MN 55082Tel.: 1.800.328.1482Fax: 1.651.351.5669www.diasorin.com
E-mail: [email protected]