Abstract
Purpose
The objective of this study is to compare how likely positive tuberculin skin test (TST) and T-SPOT®.TB (TSPOT) results predict risk factors for tuberculosis in a predominantly immigrant patient population at risk of latent TB infection (LTBI) and with rheumatologic conditions requiring immunomodulatory therapy (IMT).
Methods
Prospective study conducted at a referral rheumatology clinic. Inclusion criteria included patients on various IMT, including immunosuppressive drugs that could predispose to TB progression. We studied risk factors associated with LTBI, test results, and tests’ agreement.
Results
We studied 101 patients. Eighty (79.2 %) were from countries where TB is prevalent and Bacille Calmette-Guérin vaccination is placed routinely. Seventy-four (73.3 %) had rheumatoid arthritis and 92 (90.7 %) were on IMT. Among patients with both TST and TSPOT results, 25 (30.9 %) were TST+ and 20 (24.7 %) had TSPOT+ results. Fifteen patients (18.5 %) had TST+/TSPOT+ results, and 51 (63.0 %) had TST−/TSPOT− results (agreement = 81.5 %; kappa = .54 [95 % CI, .34–.74; P < .001]). Each TSPOT+ and TST+ results were independently associated with immigrant status and prior residence in a TB prevalent country after adjustment for immunosuppressive therapy: Adjusted ORTSPOT+=6.6 (95 % CI, 1.2–123.3; P = .027); and adjusted ORTST+=11.2 (95 % CI, 2.0–209.5; P = .003). Seven out of 10 TST+/TSPOT− cases had a TST ≥15 mm induration, including three cases with history of TST conversion.
Conclusions
TST+ and TSPOT+ results predict risk factors associated with LTBI independent of immunosuppressive IMT. Some TST+/TSPOT− results were unlikely to be false-negatives. The combined use of TST and TSPOT appears to be a reasonable diagnostic strategy to evaluate for LTBI in this population.
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Acknowledgments
We thank the support of Oxford Immunotec, manufacturer of the T-SPOT®.TB assay. This support was limited to providing laboratory reagents and laboratory technical support. Part of this project was supported by Grant Number UL1 TR000135 from the National Center for Advancing Translational Sciences (NCATS). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institute of Health. No other financial or material support was provided to the authors and participants. Dr. Escalante and his institution have filed two patent applications related to immunodiagnostic laboratory methodologies for LTBI. There is no income or royalties associated with those filed patent applications. We appreciate Ms. Gladys Hebl, Debra Hanson, and Patricia Simonson from the Research and Academic Support Services at Mayo Clinic for their excellent manuscript editing support.
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None of the authors have any other conflicts of interest to declare.
Ethical Standards
This study was conducted in accordance with the amended Declaration of Helsinki (ICH-GCP). The University of Southern California (USC) Medical Center Institutional Review Board approved the protocol (#HS-07-002125), and written informed consent was obtained from all patients.
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Escalante, P., Kooda, K.J., Khan, R. et al. Diagnosis of Latent Tuberculosis Infection with T-SPOT®.TB in a Predominantly Immigrant Population with Rheumatologic Disorders. Lung 193, 3–11 (2015). https://doi.org/10.1007/s00408-014-9655-9
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DOI: https://doi.org/10.1007/s00408-014-9655-9