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: info@diasorin.com