® RELIABLE BY DESIGN

THE T-SPOT.TB TEST DIFFERENCE

There are three commercially available tests to detect (TB) infection, these fall into two categories:

• The skin test (TST) • Interferon-gamma release assays (IGRAs) o TSTs have been used to detect TB infection for over o The T-SPOT®.TB test 100 years. They require an intradermal injection of a o QuantiFERON®-TB Gold Plus (QFT®-Plus) small amount of purified protein derivative (PPD) into the skin. In 48-72 hours, the resultant induration is measured

Accurate across patient populations | An accurate test is critical for the effectiveness of your TB screening program IGRAs TB test considerations TST The T-SPOT.TB test1 QFT-Plus2 ✗ N/A Warning in package insert Does not have a package that the predictive value of insert, but studies have Utility in immunocompromised patients ✔ a negative QFT-Plus result in demonstrated limitations immunosuppressed persons in immunocompromised has not been determined2 patients3 Sensitivity and specificity >95% ✔ ✗ ✗ FDA-approved borderline zone ✔ ✗ ✗ No cross-reactivity with BCG vaccine ✔ ✔ ✗ Objective test result ✔ ✔ ✗

Consistent results | A consistent test means you can feel confident in your result TB test considerations The T-SPOT.TB test1 QFT-Plus2 TST ✔ ✗ <1% uninterpretable test results N/A 0.6% invalid rate4 2.5% indeterminate rate2 ✗ ✔ Conversion rate of <1% in serial testing QFT-Plus: 4.3%6 N/A 0.8%5 QFT-Gold: 4.4%7

One tube with no refrigeration | An efficient process frees up your time to complete other critical priorities TB test considerations The T-SPOT.TB test1 QFT-Plus2 TST On-site incubation or refrigeration of specimen ✔ ✗ N/A is never required ✗ Single, streamlined blood collection and 3 possible collection ✔ methods requiring use of 1 N/A process or 4 tubes with up to 9 steps required2 A single visit is required ✔ ✔ ✗

For more information, please visit www.tspot.com Unique CPT code8

CPT code 86481* 86480*

Applicable test The T-SPOT.TB test QuantiFERON®-TB Gold Plus (QFT®-Plus)

Description Tuberculosis test, cell mediated immunity Tuberculosis test, cell mediated immunity response measurement; measurement of gamma interferon enumeration of gamma interferon producing antigen response producing suspension

* The listed CPT codes reflect Oxford Immunotec’s general interpretation of CPT coding requirements and are provided for informational purposes only. OXFORD IMMUNOTEC DOES NOT PROVIDE CODING ADVICE AND ASSUMES NO RESPONSIBILITY FOR BILLING ERRORS DUE TO RELIANCE ON CPT CODES LISTED IN MATERIALS PROVIDED BY OXFORD IMMUNOTEC. It is the responsibility of the billing laboratory to determine the correct CPT code to use in light of the particular circumstances.

REFERENCES: 1. Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-US-V6. Abingdon, UK. May 2017. 2. Qiagen. QuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 1095849 Rev. 02. August 2017. 3. Huebner R et al., The tuberculin skin test. Clin Infect Dis 1993; 17: 968-975. 4. Rego K, Pereira K, MacDougall J, Cruikshank W. Utility of the T-SPOT®.TB test’s borderline category to increase test resolution for results around the cut-off point. Tuberculosis. 2018;108:178-185.doi:10.1016/j.tube.2017.12.005. 5. King T et al., “T-SPOT.TB Interferon-γ Release Assay Performance in Healthcare Worker Screening at Nineteen U.S. Hospitals”, American Journal of Respiratory and Critical Care Medicine, Vol. 192, No. 3 (2015), pp. 367-373. doi: 10.1164/rccm.201501-0199OC. 6. Knierer J, Gallegos Morales EN, Schablon A, Nienhaus A, Kersten JF. QFT-Plus: a plus in variability? – Evaluation of new generation IGRA in serial testing of students with a migration background in Germany. J Occup Med Toxicol. 2017;12. doi:10.1186/s12995-016-0148-z. 7. Slater ML, Welland G, Pai M, Parsonnet J, Banaei N. Challenges with QuantiFERON-TB Gold assay for large-scale, routine screening of U.S. healthcare workers. Am J Respir Crit Care Med 2013; 188: 1005-1010. 8. American Medical Association. CPT 2016 Professional Edition. [Chicago, Ill.]: American Medical Association; 2015.

T-SPOT and the Oxford Immunotec logo are registered trademarks of Oxford Immunotec Ltd. QuantiFERON and QFT are registered trademarks of the Qiagen Group. © 2019 Oxford Immunotec. All rights reserved. TSP-US-LP-MPN160-0001 V3