Skip to main content

Advertisement

Log in

Gli esami Interferon Gamma Release Assays (IGRA) nella diagnostica tubercolare. Le nuove linee guida del Centers for Disease Control and Prevention

Interferon Gamma Release Assays (IGRA) in tuberculosis diagnosis. New Guidelines of Centers for Disease Control and Prevention

  • Il Punto
  • Published:
La Rivista Italiana della Medicina di Laboratorio - Italian Journal of Laboratory Medicine

Riassunto

Dopo l’approvazione da parte della Food and Drug Administration di due nuovi test immunologici (QFT-GIT e T-Spot) per la diagnosi di infezione da Mycobacterium tuberculosis (IGRA), il Centers for Disease Control and Prevention (CDC) ha riunito un gruppo di autorevoli esperti del settore e dei rappresentanti delle Società scientifiche maggiormente interessate, con lo scopo di esaminare le evidenze scientifiche e fornire raccomandazioni circa l’uso degli IGRA. Sono state valutate sensibilità e specificità degli esami confrontandole anche con il test cutaneo alla tubercolina (Tubercolin Skin Test, TST), in gruppi diversi di popolazioni a rischio. Il documento del CDC contiene, inoltre, raccomandazioni rivolte ad amministratori, sanitari e laboratoristi sul migliore uso dei diversi esami disponibili. Anche se i dati disponibili circa la capacità degli IGRA di predire lo sviluppo successivo di infezione tubercolare non sono numerosi, fino a questo momento questa classe di metodi non ha presentato limiti importanti.

Summary

Interferon gamma release assays (IGRA) in tuberculosis diagnosis. New Guidelines of the Centers for Disease Control and Prevention

After approval by the Food and Drug Administration of two new interferon gamma release assays (IGRA), the immunoassays QFT-GIT and T-Spot, for the diagnosis of infection with Mycobacterium tuberculosis, the Centers for Disease Control and Prevention (CDCs) convened a group of experts to review the scientific evidence and provide opinions regarding the use of IGRA. Sensitivity and specificity of IGRA were assessed in comparison with the tuberculin skin test (TST). The CDC published guidelines involving the major scientific societies in the field. The tests were evaluated in different groups of people at risk, and recommendations based on the assessment of the primary studies were developed on the best use of the tests for public health officials, health-care providers and laboratory personnel. Data on the ability of the IGRA to predict subsequent active tuberculosis are still limited, but to date no major deficiencies have been reported.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Bibliografia

  1. Mazurek GH, Jereb J, Vernon A et al (2010) Update Guidelines for using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection — United States 2010. MMWR Recomm Rep 59(RR-5):1–25

    PubMed  Google Scholar 

  2. World Health Organization (2009) Global tuberculosis control: epidemiology, strategy, financing: WHO report 2009. Geneva, World Health Organization http://www.who.int/tb/publications/global_report/2009/pdf/report_without_annexes.pdf. Data di consultazione: 28 Febbraio 2011

    Google Scholar 

  3. Mazurek GH, Villarino ME (2003) Guidelines for using the QuantiFERON-TB test for diagnosing latent Mycobacterium tuberculosis infection. Centers for Disease Control and Prevention. MMWR Recomm Rep 52(RR-2):15–18

    PubMed  Google Scholar 

  4. Converse PJ, Jones SL, Astemborski J et al (1997) Comparison of a tuberculin interferon-gamma assay with the tuberculin skin test in high-risk adults: effect of human immunodeficiency virus infection. J Infect Dis 176:144–150

    Article  PubMed  CAS  Google Scholar 

  5. Oxford Immunotec Limited (2009) T-Spot.TB 96 [U.K. package insert]. http://www.oxfordimmunotec.com/96-UK. Data di consultazione: 28 Febbraio 2011

  6. Food and Drug Administration (DATA) QuantiFERON-TB — P010033. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm084025.htm. Data di consultazione: 28 febbraio 2011

  7. Food and Drug Administration (DATA) QuantiFERON-TB Gold — P010033/S006. http://www.fda.gov/MedicalDevices/Products-andMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm110838.htm. Data di consultazione: 28 Febbraio 2011

  8. Choi JC, Shin JW, Kim JY et al (2008) The effect of previous tuberculin skin test on the follow-up examination of whole-blood interferon-gamma assay in the screening for latent tuberculosis infection. Chest 133(6):1415–1420

    Article  PubMed  CAS  Google Scholar 

  9. Leung CC, Yam WC, Yew WW et al (2008) Comparison of T-Spot. TB and tuberculin skin test among silicotic patients. Eur Respir J 31:266–272

    Article  PubMed  CAS  Google Scholar 

  10. Hill PC, Jeffries DJ, Brookes RH et al (2007) Using ELISPOT to expose false positive skin test conversion in tuberculosis contacts. PloS One 2:e183

    Article  PubMed  Google Scholar 

  11. Igari H, Watanabe A, Sato T (2007) Booster phenomenon of QuantiFERON-TB Gold after prior intradermal PPD injection. Int J Tuberc Lung Dis 11:788–791

    PubMed  CAS  Google Scholar 

  12. Naseer A, Naqvi S, Kampmann B (2007) Evidence for boosting Mycobacterium tuberculosis-specific IFN-gamma responses at 6 weeks following tuberculin skin test. Eur Respir J 29:1282–1283

    Article  PubMed  CAS  Google Scholar 

  13. Hill PC, Brookes RH, Fox A et al (2007) Longitudinal assessment of an ELISPOT test for Mycobacterium tuberculosis infection. PloS Med 4:e192

    Article  PubMed  Google Scholar 

  14. Ewer K, Millington KA, Deeks JJ et al (2006) Dynamic antigen specific T-cell responses after point-source exposure to Mycobacterium tuberculosis. Am J Respir Crit Care Med 174:831–839

    Article  PubMed  CAS  Google Scholar 

  15. Pai M, Joshi R, Dogra S et al (2006) Serial testing of health care workers for tuberculosis using interferon-gamma assay. Am J Respir Crit Care Med 174:349–355

    Article  PubMed  CAS  Google Scholar 

  16. Perry S, Sanchez L, Yang S et al (2008) Reproducibility of QuantiFERON-TB gold in-tube assay. Clin Vaccine Immunol 15:425–432

    Article  PubMed  CAS  Google Scholar 

  17. Veerapathran A, Joshi R, Goswami K et al (2008) T-cell assays for tuberculosis infection deriving cut-offs for conversions using reproducibility date. PloS ONE 3:e1850

    Article  PubMed  Google Scholar 

  18. Arend SM, Thijsen SF, Leyten EM et al (2007) Comparison of two interferon-gamma assays and tuberculin skin test for tracing tuberculosis contacts. Am J Respir Crit Care Med 175:618–627

    Article  PubMed  Google Scholar 

  19. Nakaoka H, Lawson L, Squire SB et al (2006) Risk for tuberculosis among children. Emerg Infect Dis 12:1383–1388

    PubMed  Google Scholar 

  20. Vynnycky E, Fine PE (2000) Lifetime risks, incubation period and serial interval of tuberculosis. Am J Epidemiol 152:247–263

    Article  PubMed  CAS  Google Scholar 

  21. Diel R, Loddenkemper R, Meywald-Walter K et al (2008) Predictive value of a whole blood IFN-gamma assay for the development of active tuberculosis disease after recent infection with Mycobacterium tuberculosis. Am J Respir Crit Care Med 177:1164–1170

    Article  PubMed  Google Scholar 

  22. Kik SV, Franken WP, Mensen M et al (2010) Predictive value for progression to tuberculosis by IGRA and TST in immigrant contacts. Eur Respir J 35:1346–1353

    Article  PubMed  CAS  Google Scholar 

  23. Hill PC, Jackson-Sillah DJ, Fox A et al (2008) Incidence of tuberculosis and the predictive value of ELISPOT and Mantoux tests in Gambian case contacts. PloS ONE 3:e1379

    Article  PubMed  Google Scholar 

  24. Detjen AK, Keil T, Roll S et al (2007) Interferon-gamma release assys improve the diagnosis of tuberculosis and nontuberculous mycobacterial disease in children in a country with a low incidence of tuberculosis. Clin Infect Dis 45:322–328

    Article  PubMed  CAS  Google Scholar 

  25. Kampmann B, Whittaker E, Williams A et al (2009) Interferon-gamma release assays do not identify more children with active tuberculosis then the tuberculin skin test. Eur Respir J 33:1374–1382

    Article  PubMed  CAS  Google Scholar 

  26. Tsiouris SJ, Coetzee D, Toro PL et al (2006) Sensitivity analysis and potential uses of a novel gamma interferon release assay for diagnosis of tuberculosis. J Clin Microbiol 44:2844–2850

    Article  PubMed  CAS  Google Scholar 

  27. Aichelburg MC, Rieger A, Breitenecker F et al (2009) Detection and prediction of active tuberculosis disease by a whole-blood interferon-gamma release assay in HIV-1-infected individuals. Clin Infect Dis 48:954–962

    Article  PubMed  CAS  Google Scholar 

  28. Raby E, Moyo M, Devendra A et al (2008) The effects of HIV on the sensitivity of a whole blood IFN-gamma release assay in Zambian adults with active tuberculosis. PloS One 3:e2489

    Article  PubMed  Google Scholar 

  29. Talati NJ, Seybold U, Humphrey B et al (2009) Poor concordance between interferon-gamma release assays and tuberculin skin tests in diagnosis of latent tuberculosis infection among HIV-infected individuals. BMC Infect Dis 9:15

    Article  PubMed  Google Scholar 

  30. Bocchino M, Matarese A, Bellofiore B et al (2008) Performance of two commercial blood IFN-gamma release assays for the detection of Mycobacterium tuberculosis infection in patients candidates for anti-TNF-alpha treatment. Eur J Clin Microbiol Infect Dis 27:907–913

    Article  PubMed  CAS  Google Scholar 

  31. Mandalakas AM, Hesseling AC, Chegou NN et al (2008) High level of discordant IGRA results in HIV-infected adults and children. Int J Tuberc Lung Dis 12:417–423

    PubMed  CAS  Google Scholar 

  32. Rangaka MX, Wilkinson KA, Seldon R et al (2007) Effect of HIV-1 infection on T-cell-based and skin test detection of tuberculosis infection. Am J Respir Crit Care Med 175:514–520

    Article  PubMed  Google Scholar 

  33. Stephan C, Wolf T, Goetsch U et al (2008) Comparing QuantiFERON-tuberculosis gold, T-Spot tuberculosis and tuberculin skin test in HIV-infected individuals from a low prevalence tuberculosis country. AIDS 22:2471–2479

    Article  PubMed  Google Scholar 

  34. Lindemann M, Dioury Y, Beckebaum S et al (2009) Diagnosis of tuberculosis infection in patients awaiting liver transplantation. Hum Immunol 70:24–28

    Article  PubMed  Google Scholar 

  35. Passalent L, Khan K, Richardson R et al (2007) Detecting latent tuberculosis infection in hemodialysis patients: a head-to-head comparison of the T-SPOT.TB test, tuberculin skin test, and an expert physician panel. Clin J Am Soc Nephrol 2:68–73

    Article  PubMed  Google Scholar 

  36. Piana F, Codecasa LR, Cavallerio P et al (2006) Use of a T-cell-based test for detection of tuberculosis infection among immunocompromised patients. Eur Respir J 28:31–34

    Article  PubMed  CAS  Google Scholar 

  37. Porsa E, Cheng L, Graviss EA (2007) Comparison of an ESAT-6/ CFP-10 peptide-based enzyme-linked immunospot assay to a tuberculin skin test for screenig of a population at moderate risk of contracting tuberculosis. Clin Vaccine Immunol 14:714–719

    Article  PubMed  CAS  Google Scholar 

  38. Vassilopoulos D, Stamoulis N, Hadziyannis E et al (2008) Usefulness of enzyme-linked immunospot assay (Elispot) compared to tuberculin skin testing for latent tuberculosis screening in rheumatic patients scheduled for anti-tumor necrosis factor treatment. J Rhematol 35:1271–1276

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Romolo M. Dorizzi.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Dorizzi, R.M., Billi, P., Semprini, S. et al. Gli esami Interferon Gamma Release Assays (IGRA) nella diagnostica tubercolare. Le nuove linee guida del Centers for Disease Control and Prevention . Riv Ital Med Lab 7, 11–19 (2011). https://doi.org/10.1007/s13631-011-0003-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13631-011-0003-2

Parole chiave

Key words

Navigation