Rheumatology

The T-SPOT.TB test can help you get your patients on biologics faster
Don’t let tuberculosis testing delay your patient’s treatment plan

Are indeterminate TB test results getting in the way of initiating your patient’s biologic therapy?

According to the 2012 and 2015 American College of Rheumatology (ACR) Guidelines, patients being considered for therapy with biologic agents, regardless of the presence of risk factors, should be screened for tuberculosis.1,2 Accordingly, your TB test results can have significant impact on patient care and, more importantly, the timing in which the patient can access the treatment they need. The guidelines specify:

“The panel recommends that RA patients with a positive initial or repeat TST or IGRA should have a chest radiograph and, if suggestive of active TB, a subsequent sputum examination to check for the presence of active TB. RA patients with a negative screening TST or IGRA may not need further evaluation in the absence of risk factors and/or clinical suspicion for TB. Since patients with RA may have false-negative TST or IGRA results due to immunosuppression, a negative TST or IGRA should not be interpreted as excluding the possibility that a patient has LTBI. Accordingly, in immunosuppressed RA patients with risk factors for LTBI and negative initial screening tests, the panel recommends that a repeat TST or IGRA could be considered 1–3 weeks after the initial negative screening.” 2

 

The T-SPOT.TB test advantage 

As the only TB test with sensitivity and specificity exceeding 95% in pivotal clinical studies, including in patient populations with immunosuppression, the T-SPOT.TB test is the TB test you and your patients can depend on. 3

The T-SPOT.TB test takes a fundamentally different approach to testing, enabling you to have confidence even in patients with rheumatic diseases. The T-SPOT.TB test is the only TB test that separates cells from whole blood and standardizes the number of these cells in each patient, reducing the risk of false-negative and invalid results. The T-SPOT.TB test is also the only IGRA that washes cells to enable the removal of potentially interfering substances that can affect test results.3

 

Not all IGRA tests are the same

Multiple studies  have shown that other TB test results may be affected in patients on steroid therapy4-6. Steroid use has been associated with indeterminate test results and negatively associated with a positive QFT result7.

Accurate
The only TB test with sensitivity and specificity exceeding 95% in pivotal clinical studies3

Simple
The T-SPOT.TB test is simple – requiring one visit, one tube and no special phlebotomy3

Reliable
Even in challenging testing populations, including BCG vaccinated and immunosuppressed patients3

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  1. Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis: ACR RA Treatment Recommendations. Arthritis Care & Research. 2016;68(1):1-25.
  2. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012;64: 625–39.
  3. Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-US-V5. Abingdon, UK. March 2015.
  4. Jung YJ, Woo HI, Jeon K, et al. The Significance of Sensitive Interferon Gamma Release Assays for Diagnosis of Latent Tuberculosis Infection in Patients Receiving Tumor Necrosis Factor-a Antagonist Therapy. PLoS ONE. 2015;10(10):e0141033. doi:10.1371/journal.pone.0141033.
  5. Nozawa T, Mori M, Nishimura K, et al. Usefulness of two IFN-a release assays for patients with rheumatic disease. Pediatr Int. December 2015. doi:10.1111/ped.12885.
  6. Vassilopoulos D, Tsikrika S, Hatzara C, et al. Comparison of two gamma interferon release assays and tuberculin skin testing for tuberculosis screening in a cohort of patients with rheumatic diseases starting anti-tumor necrosis factor therapy. Clin Vaccine Immunol. 2011;18(12):2102-2108. doi:10.1128/CVI.05299-11
  7. Qiagen. QuantiFERON-TB Gold (QFT) ELISA Package Insert. 1075116 Rev. 02. April 2015.