Cumulative false-positive QuantiFERON-TB interferon-γ release assay results

Annals of the American Thoracic Society

Volumn 13, Issue 5, 2016, Pages 660-665

  Gamsky, Thomas E ^a,b   Lum, Thomas ^c   Hung Fan, Melody ^a   Green, Jon A ^b,c  

^a U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

^b VA NORTHERN CALIFORNIA HEALTH CARE SYSTEM   (United States)

^c East Bay Institute for Research and Education   (United States)

Author keywords

Interferon release tests; Latent tuberculosis; Reproducibility of results; Tuberculin; Tuberculin test

Indexed keywords

ADULT; ARTICLE; DIAGNOSTIC ACCURACY; FALSE POSITIVE RESULT; FEMALE; HUMAN; LATENT TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MYCOBACTERIUM TUBERCULOSIS TEST KIT; REPRODUCIBILITY; RETROSPECTIVE STUDY; SCREENING TEST; TUBERCULIN TEST; CALIFORNIA; INTERFERON GAMMA RELEASE ASSAY; LONGITUDINAL STUDY; MASS SCREENING; PROCEDURES; STANDARDS;

ADULT; CALIFORNIA; FALSE POSITIVE REACTIONS; FEMALE; HUMANS; INTERFERON-GAMMA RELEASE TESTS; LATENT TUBERCULOSIS; LONGITUDINAL STUDIES; MALE; MASS SCREENING; REPRODUCIBILITY OF RESULTS; RETROSPECTIVE STUDIES; TUBERCULIN TEST;

EID: 84989225484     PISSN: 23256621     EISSN: None     Source Type: Journal    
DOI: 10.1513/AnnalsATS.201508-532OC     Document Type: Article

References (39)

1. Mazurek GH, Jereb J, Vernon A, LoBue P, Goldberg S, Castro K; IGRA Expert Committee; Centers for Disease Control and Prevention (CDC). Updated guidelines for using interferon gamma release assays to detect Mycobacterium tuberculosis infection?United States, 2010. MMWR Recomm Rep 2010;59:1-25.
2. Rangaka MX, Wilkinson KA, Glynn JR, Ling D, Menzies D, Mwansa-Kambafwile J, Fielding K, Wilkinson RJ, Pai M. Predictive value of interferon-g release assays for incident active tuberculosis: A systematic review and meta-analysis. Lancet Infect Dis 2012;12: 45-55.
3. Weddle G, Hamilton M, Potthoff D, Rivera D, Jackson MA. QuantiFERON-TB Gold in-tube testing for tuberculosis in healthcare professionals. Lab Med 2014;45:207-210.
4. 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.
5. Joshi M, Monson TP, Joshi A, Woods GL. IFN-g release assay conversions and reversions: Challenges with serial testing in U.S. health care workers. Ann Am Thorac Soc 2014;11:296-302.
6. Pai M, Denkinger CM, Kik SV, Rangaka MX, Zwerling A, Oxlade O, Metcalfe JZ, Cattamanchi A, Dowdy DW, Dheda K, et al. Gamma interferon release assays for detection of Mycobacterium tuberculosis infection. Clin Microbiol Rev 2014;27:3-20.
7. Gray J, Reves R, Johnson S, Belknap R. Identification of false-positive QuantiFERON-TB Gold In-Tube assays by repeat testing in HIVinfected patients at low risk for tuberculosis. Clin Infect Dis 2012;54: E20-e23.
8. Dorman SE, Belknap R, Graviss EA, Reves R, Schluger N, Weinfurter P, Wang Y, Cronin W, Hirsch-Moverman Y, Teeter LD, et al.; Tuberculosis Epidemiologic Studies Consortium. Interferon-g release assays and tuberculin skin testing for diagnosis of latent tuberculosis infection in healthcare workers in the United States. Am J Respir Crit Care Med 2014;189:77-87.
9. Slater M, Parsonnet J, Banaei N. Investigation of false-positive results given by the QuantiFERON-TB Gold In-Tube assay. J Clin Microbiol 2012;50:3105-3107.
10. Zwerling A, Cojocariu M, McIntosh F, Pietrangelo F, Behr MA, Schwartzman K, Benedetti A, Dendukuri N, Menzies D, Pai M. TB screening in Canadian health care workers using interferon-g release assays. PLoS One 2012;7:e43014.
11. Fong KS, Tomford JW, Teixeira L, Fraser TG, van Duin D, Yen-Lieberman B, Gordon SM, Miranda C. Challenges of interferon-g release assay conversions in serial testing of health-care workers in a TB control program. Chest 2012;142:55-62.
12. Pai M, Elwood K. Interferon-g release assays for screening of health care workers in low tuberculosis incidence settings: Dynamic patterns and interpretational challenges. Can Respir J 2012;19: 81-83.
13. Zwerling A, Benedetti A, Cojocariu M, McIntosh F, Pietrangelo F, Behr MA, Schwartzman K, Menzies D, Pai M. Repeat IGRA testing in Canadian health workers: Conversions or unexplained variability?. PLoS One 2013;8:e54748.
14. 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.
15. Metcalfe JZ, Cattamanchi A, McCulloch CE, Lew JD, Ha NP, Graviss EA. Test variability of the QuantiFERON-TB gold in-tube assay in clinical practice. Am J Respir Crit Care Med 2013;187:206-211.
16. Daley CL, Reves RR, Beard MA, Boyle J, Clark RB, Beebe JL, Catanzaro A, Chen L, Desmond E, Dorman SE, et al. A summary of meeting proceedings on addressing variability around the cut point in serial interferon-g release assay testing. Infect Control Hosp Epidemiol 2013;34:625-630.
17. Gandra S, Scott WS, Somaraju V, Wang H, Wilton S, Feigenbaum M. Questionable effectiveness of the QuantiFERON-TB Gold Test (Cellestis) as a screening tool in healthcare workers. Infect Control Hosp Epidemiol 2010;31:1279-1285.
18. Tagmouti S, Slater M, Benedetti A, Kik SV, Banaei N, Cattamanchi A, Metcalfe J, Dowdy D, van Zyl Smit R, Dendukuri N, et al. Reproducibility of interferon gamma (IFN-g) release assays: A systematic review. Ann Am Thorac Soc 2014;11:1267-1276.
19. Ringshausen FC, Schablon A, Nienhaus A. Interferon-g release assays for the tuberculosis serial testing of health care workers: A systematic review. J Occup Med Toxicol 2012;7:6.
20. Ringshausen FC, Nienhaus A, Torres Costa J, Knoop H, Schlösser S, Schultze-Werninghaus G, Rohde G. Within-subject variability of Mycobacterium tuberculosis-specific gamma interferon responses in German health care workers. Clin Vaccine Immunol 2011;18: 1176-1182.
21. Whitworth WC, Hamilton LR, Goodwin DJ, Barrera C, West KB, Racster L, Daniels LJ, Chuke SO, Campbell BH, Bohanon J, et al. Within-subject interlaboratory variability of QuantiFERON-TB gold in-tube tests. PLoS One 2012;7:e43790.
22. van Zyl-Smit RN, Zwerling A, Dheda K, Pai M. Within-subject variability of interferon-g assay results for tuberculosis and boosting effect of tuberculin skin testing: A systematic review. PLoS One 2009;4: E8517.
23. Whitworth WC, Goodwin DJ, Racster L, West KB, Chuke SO, Daniels LJ, Campbell BH, Bohanon J, Jaffar AT, Drane W, et al. Variability of the QuantiFERON®-TB gold in-tube test using automated and manual methods. PLoS One 2014;9:e86721.
24. Joshi M, Monson TP, Woods GL. Use of interferon-g release assays in a health care worker screening program: Experience from a tertiary care centre in the United States. Can Respir J 2012;19: 84-88.
25. Zwerling A, van den Hof S, Scholten J, Cobelens F, Menzies D, Pai M. Interferon-g release assays for tuberculosis screening of healthcare workers: A systematic review. Thorax 2012;67:62-70.
26. Thanassi W, Noda A, Hernandez B, Newell J, Terpeluk P, Marder D, Yesavage JA. Delineating a retesting zone using receiver operating characteristic analysis on serial QuantiFERON tuberculosis test results in US healthcare workers. Pulm Med 2012;2012:291294.
27. Pollock NR, McAdam AJ, Pai M, Nardell EA, Bernardo J, Banaei N, Mobo J. Interferon g-release assays for diagnosis of latent tuberculosis in healthcare workers in low-incidence settings: Pros and cons. Clin Chem 2014;60:714-718.
28. McMullen SE, Pegues DA, Shofer FS, Sheller AC, Wiener EB. Performance of QuantiFERON-TB Gold and tuberculin skin test relative to subjects' risk of exposure to tuberculosis. Clin Infect Dis 2014;58:1260-1266.
29. Lucet JC, Abiteboul D, Estellat C, Roy C, Chollet-Martin S, Tubach F, Carcelain G; QUANTIPS Study Group. Interferon-g release assay vs. tuberculin skin test for tuberculosis screening in exposed healthcare workers: A longitudinal multicenter comparative study. Infect Control Hosp Epidemiol 2015;36:569-574.
30. Diel R, Nienhaus A. Current issues arising from tuberculosis screening with interferon-ga release assays (IGRAs). Pneumologie 2015;69: 271-275.
31. Baldessarini RJ, Finklestein S, Arana GW. The predictive power of diagnostic tests and the effect of prevalence of illness. Arch Gen Psychiatry 1983;40:569-573.
32. Hubbard RA, Miglioretti DL, Smith RA. Modelling the cumulative risk of a false-positive screening test. Stat Methods Med Res 2010;19: 429-449.
33. Croswell JM, Kramer BS, Kreimer AR, Prorok PC, Xu JL, Baker SG, Fagerstrom R, Riley TL, Clapp JD, Berg CD, et al. Cumulative incidence of false-positive results in repeated, multimodal cancer screening. Ann Fam Med 2009;7:212-222.
34. Elmore JG, Barton MB, Moceri VM, Polk S, Arena PJ, Fletcher SW. Ten-year risk of false positive screening mammograms and clinical breast examinations. N Engl J Med 1998;338:1089-1096.
35. Contra Costa Health Services. Tuberculosis in Contra Costa County 2013 [accessed 2016 Feb 1]. Available from: Http://cchealth.org/tb/ pdf/Infographic-2013.pdf
36. Cellestis QuantiFERON-TB Gold package insert, 2007, 2009-2011, 2013. Available from: Http://www.quantiferon.com/irm/content/PI/ QFT/2PK/UK.pdf
37. Jensen PA, Lambert LA, Lademarco MF, Ridzon R; Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Recomm Rep 2005;54:1-141.
38. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med 2000;161(Suppl 3): S221-S247.
39. World Health Organization. Global tuberculosis report 2013. Geneva, Switzerland: Author; 2013 [accessed 2016 Feb 1]. Available from: Http://apps.who.int/iris/bitstream/10665/91355/1/9789241564656-eng.pdf