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The T-SPOT®.TB test is the only TB test with sensitivity of 98.8% and specificity above 99%.1

References

  1. Dye C, Floyd K. Tuberculosis. In: Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, Jha P, Mills A, Musgrove P, editors. Disease Control Priorities in Developing Countries, 2nd ed. Washington (DC); 2006.
  2. CDC. Core Curriculum on Tuberculosis: What the Clinician Should Know. 6th Edition. Department of Health and Human Services 2013.
  3. WHO. Global Tuberculosis Report 2014. 2015.
  4. WHO. Guidelines on the Management of Latent Tuberculosis Infection. Guidelines on the Management of Latent Tuberculosis Infection. Geneva; 2015.
  5. Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven‑Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR, Jr., Chaisson RE, Team TBTCPTS. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med 2011; 365: 2155‑2166.
  6. Huebner RE, Schein MF, Bass JB, Jr. The tuberculin skin test. Clin Infect Dis 1993; 17: 968‑975.
  7. Wrighton‑Smith P, Sneed L, Humphrey F, Tao X, Bernacki E. Screening health care workers with interferon‑gamma release assay versus tuberculin skin test: impact on costs and adherence to testing (the SWITCH study). J Occup Environ Med 2012; 54: 806‑815.
  8. Oxford Immunotec Ltd. T‑SPOT.TB Package Insert PI‑TB‑US‑V4 Abingdon, UK. 2013.
  9. Oxford Immunotec Ltd. T‑SPOT.TB Package Insert PI‑TB‑JP‑V6 Abingdon, UK. 2014.
  10. Oxford Immunotec Ltd. T‑SPOT.TB Package Insert PI‑TB8‑IVD‑UK‑V5CH Abingdon, UK. 2013.
  11. Oxford Immunotec Ltd. T‑SPOT.TB Package Insert PPI‑TB‑IVD‑UK‑V2 Abingdon, UK. 2013.
  12. Mazurek GH, Jereb J, Vernon A, LoBue P, Goldberg S, Castro K, Committee IE, Centers for Disease C, Prevention. Updated guidelines for using Interferon Gamma Release Assays to detect Mycobacterium tuberculosis infection ‑ United States, 2010. MMWR Recomm Rep 2010; 59: 1‑25.
  13. Diel R, Loytved G, Nienhaus A, Castell S, Detjen A, Geerdes‑Fenge H, Haas W, Hauer B, Konigstein B, Maffei D, Magdorf K, Priwitzer M, Zellweger JP, Loddenkemper R. [New recommendations for contact tracing in tuberculosis. German Central Committee against Tuberculosis]. Pneumologie 2011; 65: 359‑378.
  14. Cavalcanti YV, Brelaz MC, Neves JK, Ferraz JC, Pereira VR. Role of TNF‑Alpha, IFN‑Gamma, and IL‑10 in the Development of Pulmonary Tuberculosis. Pulm Med 2012; 2012: 745483.
  15. Franken WP, Koster BF, Bossink AW, Thijsen SF, Bouwman JJ, van Dissel JT, Arend SM. Follow‑up study of tuberculosis‑exposed supermarket customers with negative tuberculin skin test results in association with positive gamma interferon release assay results. Clin Vaccine Immunol 2007; 14: 1239‑1241.
  16. Zhang S, Shao L, Mo L, Chen J, Wang F, Meng C, Zhong M, Qiu L, Wu M, Weng X, Zhang W. Evaluation of gamma interferon release assays using Mycobacterium tuberculosis antigens for diagnosis of latent and active tuberculosis in Mycobacterium bovis BCG‑vaccinated populations. Clin Vaccine Immunol 2010; 17: 1985‑1990.
  17. Bosshard V, Roux‑Lombard P, Perneger T, Metzger M, Vivien R, Rochat T, Janssens JP. Do results of the T‑SPOT.TB interferon‑gamma release assay change after treatment of tuberculosis? Respir Med 2009; 103: 30‑34.
  18. Walzl G, Ronacher K, Hanekom W, Scriba TJ, Zumla A. Immunological biomarkers of tuberculosis. Nat Rev Immunol 2011; 11: 343‑354.
  19. King TC, Upfal M, Gottlieb A, Adamo P, Bernacki E, Kadlecek CP, Jones JG, Humphrey‑Carothers F, Rielly AF, Drewry P, Murray K, DeWitt M, Matsubara J, O’Dea L, Balser J, Wrighton‑Smith P. T‑SPOT®.TB Interferon‑Gamma Release Assay (IGRA) Performance in Healthcare Worker Screening at 19 US Hospitals. American Journal of Respiratory and Critical Care Medicine 2015: 150527134833008.
  20. Koller MD, Kiener HP, Aringer M, Graninger WB, Meuer S, Samstag Y, Smolen JS. Functional and molecular aspects of transient T cell unresponsiveness: role of selective interleukin‑2 deficiency. Clin Exp Immunol 2003; 132: 225‑231.
  21. Bienek DR, Chang CK. Evaluation of an interferon‑gamma release assay, T‑SPOT.TB, in a population with a low prevalence of tuberculosis. Int J Tuberc Lung Dis 2009; 13: 1416‑1421.
  22. Wang SH, Stew SS, Cyktor J, Carruthers B, Turner J, Restrepo BI. Validation of increased blood storage times with the T‑SPOT.TB assay with T‑Cell Xtend reagent in individuals with different tuberculosis risk factors. J Clin Microbiol 2012; 50: 2469‑2471.
  23. Talbot EA, Maro I, Ferguson K, Adams LV, Mtei L, Matee M, von Reyn CF. Maintenance of Sensitivity of the T‑SPOT.TB Assay after Overnight Storage of Blood Samples, Dar es Salaam, Tanzania. Tuberc Res Treat 2012; 2012: 345290.
  24. Mancuso JD, Mazurek GH, Tribble D, Olsen C, Aronson NE, Geiter L, Goodwin D, Keep LW. Discordance among commercially available diagnostics for latent tuberculosis infection. Am J Respir Crit Care Med 2012; 185: 427‑434.
  25. WHO. WHO Informal Consultation on Standardization and Evaluation of BCG Vaccines 2009.
  26. Starke JR, Committee On Infectious D. Interferon‑gamma release assays for diagnosis of tuberculosis infection and disease in children. Pediatrics 2014; 134: e1763‑1773.
  27. Lewis KN, Liao R, Guinn KM, Hickey MJ, Smith S, Behr MA, Sherman DR. Deletion of RD1 from Mycobacterium tuberculosis mimics bacille Calmette‑Guerin attenuation. J Infect Dis 2003; 187: 117‑123.
  28. Xia Z, DePierre JW, Nassberger L. Tricyclic antidepressants inhibit IL‑6, IL‑1 beta and TNF‑alpha release in human blood monocytes and IL‑2 and interferon‑gamma in T cells. Immunopharmacology 1996; 34: 27‑37.
  29. Iniguez MA, Punzon C, Fresno M. Induction of cyclooxygenase‑2 on activated T lymphocytes: regulation of T cell activation by cyclooxygenase‑2 inhibitors. J Immunol 1999; 163: 111‑119.
  30. Pooran A, Booth H, Miller RF, Scott G, Badri M, Huggett JF, Rook G, Zumla A, Dheda K. Different screening strategies (single or dual) for the diagnosis of suspected latent tuberculosis: a cost effectiveness analysis. BMC Pulm Med 2010; 10: 7.
  31. Wrighton‑Smith P, Zellweger JP. Direct costs of three models for the screening of latent tuberculosis infection. Eur Respir J 2006; 28: 45‑50.
  32. Diel R, Wrighton‑Smith P, Zellweger JP. Cost‑effectiveness of interferon‑gamma release assay testing for the treatment of latent tuberculosis. Eur Respir J 2007; 30: 321‑332.
  33. Foster‑Chang SA, Manning ML, Chandler L. Tuberculosis screening of new hospital employees: compliance, clearance to work time, and cost using tuberculin skin test and interferon‑gamma release assays. Workplace Health Saf 2014; 62: 460‑467.
  34. Oxford Immunotec Ltd. T‑Cell Xtend Package Insert PI‑TT.610‑US‑V4 Abingdon, UK. 2013.
  35. McKenna KC, Beatty KM, Vicetti Miguel R, Bilonick RA. Delayed processing of blood increases the frequency of activated CD11b+ CD15+ granulocytes which inhibit T cell function. J Immunol Methods 2009; 341: 68‑75.
  36. Bouwman JJ, Thijsen SF, Bossink AW. Improving the timeframe between blood collection and interferon gamma release assay using T‑Cell Xtend(R). J Infect 2012; 64: 197‑203.
  37. Wang SH, Powell DA, Nagaraja HN, Morris JD, Schlesinger LS, Turner J. Evaluation of a modified interferon‑gamma release assay for the diagnosis of latent tuberculosis infection in adult and paediatric populations that enables delayed processing. Scand J Infect Dis 2010; 42: 845‑850.
  38. Cox JH, Ferrari G, Janetzki S. Measurement of cytokine release at the single cell level using the ELISPOT assay. Methods 2006; 38: 274‑282.

 

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