QFT-Plus: A plus in variability? - Evaluation of new generation IGRA in serial testing of students with a migration background in Germany

Journal of Occupational Medicine and Toxicology

Volumn 12, Issue 1, 2017, Pages

  Knierer, J ^a   Gallegos Morales, E N ^a   Schablon, A ^a   Nienhaus, A ^a,b   Kersten, J F ^a  

^a UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^b Institution for Statutory Accident Insurance and Prevention in the Health and Welfare Services   (Germany)

Author keywords

Latent tuberculosis infection; QFT Plus; Serial testing; Students; Variability

Indexed keywords

GAMMA INTERFERON;

ADULT; ARTICLE; CLINICAL ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; CYTOKINE RELEASE; DIAGNOSTIC TEST ACCURACY STUDY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; GERMANY; HIGH RISK PATIENT; HUMAN; INCIDENCE; INFECTION RISK; INTERFERON GAMMA RELEASE ASSAY; LUNG TUBERCULOSIS; MALE; MIGRATION; QUANTIFERON TB GOLD IN TUBE ASSAY; QUANTIFERON TB GOLD PLUS ASSAY; SENSITIVITY AND SPECIFICITY; THORAX RADIOGRAPHY;

EID: 85008395044     PISSN: None     EISSN: 17456673     Source Type: Journal    
DOI: 10.1186/s12995-016-0148-z     Document Type: Article

References (35)

1. U.S. Food and Drug Administration CfDaRH. QuantiFERON® -TB - P010033. Rockville; 2016. Approval letter. http://www.accessdata.fda.gov/cdrh-docs/pdf//p010033a.pdf. Accessed 16 Jun 2016.
2. Nienhaus A, Ringshausen FC, Costa JT, Schablon A, Tripodi D. IFN-gamma release assay versus tuberculin skin test for monitoring TB infection in healthcare workers. Expert Rev Anti Infect Ther. 2013;11:37-48.
3. Pai M, Zwerling A, Menzies D. Systematic review: T-cell-based assays for the diagnosis of latent tuberculosis infection: an update. Ann Intern Med. 2008;149:177-84.
4. Diel R, Loddenkemper R, Nienhaus A. Evidence-Based Comparison of Commercial Interferon-gamma Release Assays for Detecting Active TB. Chest. 2010;137:952-68.
5. Sester M, Sotgiu G, Lange C, Giehl C, Girardi E, Migliori GB, Bossink A, Dheda K, Diel R, Dominguez J, et al. Interferon-gamma release assays for the diagnosis of active tuberculosis: a systematic review and meta-analysis. Eur RespirJ. 2011;37:100-11.
6. Zwerling A, van den Hof S, Scholten J, Cobelens F, Menzies D, Pai M. Interferon-gamma release assays for tuberculosis screening of healthcare workers: a systematic review. Thorax. 2012;67:62-70.
7. Pai M. Serial Testing With TB Interferon-gamma Release Assays Toward a Nuanced Understanding. Chest. 2012;142:1366-8.
8. Tagmouti S, Slater M, Benedetti A, Kik SV, Banaei N, Cattamanchi A, Metcalfe J, Dowdy D, van Zyl SR, Dendukuri N, et al. Reproducibility of interferon gamma (IFN-gamma) release Assays. A systematic review. Ann Am Thorac Soc. 2014;11:1267-76.
9. Ringshausen FC, Schablon A, Nienhaus A. Interferon-gamma release assays for the tuberculosis serial testing of health care workers: a systematic review. J Occup Med Toxicol. 2012;7.
10. Schablon A, Harling M, Diel R, Ringshausen FC, Torres Costa J, Nienhaus A. Serial testing with an interferon-γ release assay in German healthcare workers. GMS Krankenhhyg Interdiszip. 2010;5:Doc 05.
11. Perry S, Sanchez L, Yang SF, Agarwal Z, Hurst P, Parsonnet J. Reproducibility of QuantiFERON-TB gold in-tube assay. Clin Vaccine Immunol. 2008;15:425-32.
12. Pai M, Kunimoto D, Jamieson F, Menzies D. Diagnosis of latent tuberculosis infection. Can Respir J. 2013;20:23a-34a.
13. Mazurek GH, Jereb J, Vernon A, LoBue P, Goldberg S, Castro K, IGRA Expert Committee, Centers for Disease Control and Prevention. Updated guidelines for using Interferon Gamma Release Assays to detect Mycobacterium tuberculosis infection - United States. MMWR Recomm Rep. 2010;59:1-2.
14. European Centre for Disease Prevention and Control. Use of interferon-gamma release assays in support of TB diagnosis. Stockholm: ECDC; 2011:3-38.
15. Pai M, Elwood K. Interferon-gamma release assays for screening of health care workers in low tuberculosis incidence settings: dynamic patterns and interpretational challenges. Can Respir J. 2012;19:81-3.
16. Schablon A, Nienhaus A, Ringshausen FC, Preisser AM, Peters C. Occupational screening for tuberculosis and the use of a borderline zone for interpretation of the IGRA in German healthcare workers. PLoS One. 2014;9, e115322.
17. Ringshausen FC, Nienhaus A, Costa JT, Knoop H, Schlosser 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;18:1176-82.
18. 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.
19. Thanassi W, Noda A, Hernandez B, Friedman L, Dorman S, Yesavage J. Negative Tuberculin Skin Test and Prediction of Reversion of QuantiFERON Interferon Gamma Release Assay in US Healthcare Workers. Infect Control Hosp Epidemiol. 2016;37(4):478-82.
20. Ringshausen FC, Nienhaus A, Schablon A, Schlosser S, Schultze-Werninghaus G, Rohde G. Predictors of persistently positive Mycobacterium-tuberculosis-specific interferon-gamma responses in the serial testing of health care workers. BMC Infect Dis. 2010;10:220.
21. Qiagen. QIAGEN launches QuantiFERON®-TB Gold Plus - a new generation of the most accurate test for detecting tuberculosis infections 2015, press release 7 Jan 2015. https://www.qiagen.com/de/about-us/press-releases/pressreleaseview?ID={C861949E-DF50-475B-8148-B4C70034C49E}&lang=en. Accessed 16 Jun 2016.
22. Barcellini L, Borroni E, Brown J, Brunetti E, Codecasa L, Cugnata F, Dal Monte P, Di Serio C, Goletti D, Lombardi G, et al. First independent evaluation of QuantiFERON-TB Plus performance. Eur Respir J. 2016;47:1587-90.
23. WHO World Health Oraganization. Global Health Observatory data repository. Incidence Data by country (2007 - present) http://apps.who.int/gho/data/node.main.1320?lang=en (2016). Accessed 16 Jun 2016.
24. 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.
25. Qiagen. QuantiFERON®-TB Gold Plus (QFT®-Plus) ELISA Package Insert. http://www.quantiferon.com/irm/content/PI/QFT/PLUS/2PK-Elisa/UK.pdf (2015). Accessed 16 Jun 2016.
26. Gaur RL, Pai M, Banaei N. Impact of blood volume, tube shaking, and incubation time on reproducibility of QuantiFERON-TB gold in-tube assay. J Clin Microbiol. 2013;51:3521-6.
27. Cicchetti DV. Guidelines, Criteria, and Rules of Thumb for Evaluating Normed and Standardized Assessment Instruments in Psychology. Psychol Assess. 1994;6:284-90.
28. WHO. Global Tuberculosis Report 2015. Geneva: World Health Organization; 2015. p. 1-192.
29. Barnett AG, van der Pols JC, Dobson AJ. Regression to the mean: what it is and how to deal with it. Int J Epidemiol. 2005;34:215-20.
30. King TC, Upfal M, Gottlieb A, Adamo P, Bernacki E, Kadlecek CP, Jones JG, Humphrez-Carothers F, Rielly AF, Drewry P, Murray K, DeWitt M, Matsubara J, O'Dea L, Balser J, Wrighton-Smith P. T-SPOT.TB Interferon-γ Release Assay Performance in Healthcare Worker Screening at Nineteen U.S. Hospitals. Am J Respir Crit Care Med. 2015;192(3):367-73.
31. Saldan A, Forner G, Mengoli C, Tinto D, Fallico L, Peracchi M, Gussetti N, Palù G, Abate D. Comparison of the Cytomegalovirus (CMV) Enzyme-Linked Immunosorbent Spot and CMV QuantiFERON Cell-Mediated Immune Assays in CMV-Seropositive and -Seronegative Pregnant and Nonpregnant Women. J Clin Microbiol. 2016;54(5):1352-6.
32. Zwerling A, Pai M, Michael JS, Christopher DJ. Serial testing using interferon-gamma release assays in nursing students in India. Eur Respir J. 2014;44:257-60.
33. Pai M, Denkinger CM, Kik SV, Rangaka MX, Zwerling A, Oxlade O, Metcalfe JZ, Cattamanchi A, Dowdy DW, Dheda K, Banaei N. Gamma Interferon Release Assays for Detection of Mycobacterium tuberculosis Infection. Clin Microbiol Rev. 2014;27:3-20.
34. Andrews JR, Hatherill M, Mahomed H, Hanekom WA, Campo M, Hawn TR, Wood R, Scriba TJ. The dynamics of QuantiFERON-TB gold in-tube conversion and reversion in a cohort of South African adolescents. Am J Respir Crit Care Med. 2015;191(5):584-91.
35. Ritz N, Yau C, Connell TG, Tebruegge M, Leslie D, Curtis N. Absence of interferon-gamma release assay conversion following tuberculin skin testing. Int J Tuberc Lung Dis. 2011;15:767-9.