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Lee, Cho, Kang, Park, Lee, Lee, Jeon, and Choi: The Usefulness of Whole-blood Interferon-gamma Release Assay for the Diagnosis of Extra-pulmonary Tuberculosis
Original Article
Tuberculosis and Respiratory Diseases

Tuberculosis and Respiratory Diseases 2009; 67(4): 331-337.

Published online: 31 October 2009

DOI: https://doi.org/10.4046/trd.2009.67.4.331

The Usefulness of Whole-blood Interferon-gamma Release Assay for the Diagnosis of Extra-pulmonary Tuberculosis

Hye-Min Lee, M.D., Sung Gun Cho, M.D., Hyung Koo Kang, M.D., Sung Woon Park, M.D., Byung Ook Lee, M.D., Jae Hee Lee, M.D., Eun Ju Jeon, M.D., Jae Chol Choi, M.D.

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.

Address for correspondence: Jae Chol Choi, M.D. Division of Pulmonary and Critical Care Medicine, Department of Medicine, Chung-Ang University Medical Center, 65-207, Hangangno 3-ga, Youngsan-gu, Seoul 140-757, Korea. Phone: 82-2-748-9804, Fax: 82-2-749-9560, medics27@cau.ac.kr

Received 23 July 2009       Accepted 7 September 2009

Copyright©2009. The Korean Academy of Tuberculosis and Respiratory Diseases. All rights reserved.

Abstract

Background

The whole-blood interferon-gamma release assay (QuantiFERON-TB Gold [QFT-G]: Cellestis, Carnegie, Victoria, Australia) has been studied primarily for the use of diagnosing active pulmonary tuberculosis (TB) or latent TB. In the present study, the usefulness of QFT-G was evaluated for the diagnosis of extra-pulmonary tuberculosis (EP-TB).

Methods

From June 2006 to February 2009, we evaluated the usefulness of QFT-G in patients (n=65) suspected with EP-TB, retrospectively. The diagnostic sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the QFT-G assay were analyzed.

Results

EP-TB was diagnosed in 33 (51%) participants. The overall sensitivity, specificity, PPV, and NPV of the QFT-G assay for EP-TB were 78%, 79%, 81%, and 77%, respectively. Of the 33 with EP-TB, 14 (42%) were diagnosed with TB pleurisy, 7 (21%) with TB lymphadenitis, 7 (21%) with intestinal TB, and 5 (15%) with EP-TB in other sites. In subgroup analyses according by site of infection, the QFT-G showed 86% sensitivity, 64% specificity, and 78% NPV in TB pleurisy. On the other hand, the sensitivity, specificity, and NPV of the assay were 71%, 83% and 71%, respectively in TB lymphadenitis, and 86%, 100% and 88%, respectively in intestinal TB. Among the patients with suspected alternative site EP-TB, the sensitivity, specificity, and NPV of the assay were 50%, 80% and 67%, respectively.

Conclusion

The QFT-G assay showed moderate diagnostic accuracy in EP-TB. However, negative QFT-G assay does not exclude EP-TB because of the low NPV of this assay.

Keywords: Mycobacterium tuberculosis, Interferon-gamma, Diagnosis

Figures and Tables

Table 1
Demographic and clinical characteristics of the patients with suspected extra-pulmonary tuber
trd-67-331-i001

Data are no. (%) of patients, unless otherwise indicated.

EP-TB: extra-pulmonary tuberculosis; TB: tuberculosis; HIV: human immunodeficiency virus.

Table 2
Distribution of the site of infection with suspected extra-pulmonary tuberculosis
trd-67-331-i002

Data are no. (%) of patients, unless otherwise indicated.

EP-TB: extra-pulmonary tuberculosis.

Table 3
Results of the interferon gamma release assay among 65 patients with suspected extra-pulmonary tuberculosis, by patient population subgroup
trd-67-331-i003

EP-TB: extra-pulmonary tuberculosis; IGRA: interferon gamma release assay; PPV: positive predictive value; NPV: negative predictive value; CI95: confidence interval 95%.

Table 4
Characteristics of patients who had verified cases of extra-pulmonary tuberculosis diagnosed
trd-67-331-i004

Data are no. (%) of patients, unless otherwise indicated.

IGRA: interferon gamma release assay.

Notes

This research was supported by the Chung-Ang University Research Grants in 2007.

References

1. World Health Organization. Global tuberculosis control: surveillance, planning, financing, WHO/HTM/TB/2008.393. 2008. Geneva: World Health Organization.
2. Korea Center for Disease Control and Prevention, Korean Institute of Tuberculosis. Annual report on the notified tuberculosis patients in Korea. 2008. Seoul: Korea Center for Disease Control and Prevention, Korean Institute of Tuberculosis.
3. Lew WJ. Tuberculosis surveillance system in Korea. Tuberc Respir Dis. 2000. 48:298–307.
4. Steingart KR, Henry M, Laal S, Hopewell PC, Ramsay A, Menzies D, et al. A systematic review of commercial serological antibody detection tests for the diagnosis of extrapulmonary tuberculosis. Postgrad Med J. 2007. 83:705–712.
5. Shim TS, Koh WJ, Yim JJ, Lew WJ. Diagnosis and treatment of latent tuberculosis infection in Korea. Tuberc Respir Dis. 2004. 57:101–108.
6. Pai M, Riley LW, Colford JM Jr. Interferon-gamma assays in the immunodiagnosis of tuberculosis: a systematic review. Lancet Infect Dis. 2004. 4:761–776.
7. Nishimura T, Hasegawa N, Mori M, Takebayashi T, Harada N, Higuchi K, et al. Accuracy of an interferon-gamma release assay to detect active pulmonary and extra-pulmonary tuberculosis. Int J Tuberc Lung Dis. 2008. 12:269–274.
8. Mazurek GH, LoBue PA, Daley CL, Bernardo J, Lardizabal AA, Bishai WR, et al. Comparison of a whole-blood interferon gamma assay with tuberculin skin testing for detecting latent Mycobacterium tuberculosis infection. JAMA. 2001. 286:1740–1747.
9. Menzies D, Pai M, Comstock G. Meta-analysis: new tests for the diagnosis of latent tuberculosis infection: areas of uncertainty and recommendations for research. Ann Intern Med. 2007. 146:340–354.
10. Dewan PK, Grinsdale J, Kawamura LM. Low sensitivity of a whole-blood interferon-gamma release assay for detection of active tuberculosis. Clin Infect Dis. 2007. 44:69–73.
11. Mori T, Sakatani M, Yamagishi F, Takashima T, Kawabe Y, Nagao K, et al. Specific detection of tuberculosis infection: an interferon-gamma-based assay using new antigens. Am J Respir Crit Care Med. 2004. 170:59–64.
12. Ferrara G, Losi M, D'Amico R, Roversi P, Piro R, Meacci M, et al. Use in routine clinical practice of two commercial blood tests for diagnosis of infection with Mycobacterium tuberculosis: a prospective study. Lancet. 2006. 367:1328–1334.
13. Munk ME, Arend SM, Brock I, Ottenhoff TH, Andersen P. Use of ESAT-6 and CFP-10 antigens for diagnosis of extrapulmonary tuberculosis. J Infect Dis. 2001. 183:175–176.
14. Song KH, Jeon JH, Park WB, Kim SH, Park KU, Kim NJ, et al. Usefulness of the whole-blood interferon-gamma release assay for diagnosis of extrapulmonary tuberculosis. Diagn Microbiol Infect Dis. 2009. 63:182–187.
15. Burgess LJ, Maritz FJ, Le Roux I, Taljaard JJ. Use of adenosine deaminase as a diagnostic tool for tuberculous pleurisy. Thorax. 1995. 50:672–674.
16. Park EB, Jeen YT, Ahn JH, Suh SJ, Lee SJ, Park NS, et al. Intestinal tuberculosis with a duodenal fistula. Korean J Gastrointest Endosc. 2007. 35:346–350.
17. Lee YS, Jung JO, Hong JH, Seo YI, Eom KS, Jang SH, et al. Occurrence of tuberculous pleurisy associated with infliximab therapy. Korean J Med. 2004. 67:421–424.
18. Engin G, Acunas B, Acunas G, Tunaci M. Imaging of extrapulmonary tuberculosis. Radiographics. 2000. 20:471–488.
19. Pai M, Gokhale K, Joshi R, Dogra S, Kalantri S, Mendiratta DK, et al. Mycobacterium tuberculosis infection in health care workers in rural India: comparison of a whole-blood interferon gamma assay with tuberculin skin testing. JAMA. 2005. 293:2746–2755.
20. Brock I, Weldingh K, Lillebaek T, Follmann F, Andersen P. Comparison of tuberculin skin test and new specific blood test in tuberculosis contacts. Am J Respir Crit Care Med. 2004. 170:65–69.
21. Ewer K, Deeks J, Alvarez L, Bryant G, Waller S, Andersen P, et al. Comparison of T-cell-based assay with tuberculin skin test for diagnosis of Mycobacterium tuberculosis infection in a school tuberculosis outbreak. Lancet. 2003. 361:1168–1173.
22. Dosanjh DP, Hinks TS, Innes JA, Deeks JJ, Pasvol G, Hackforth S, et al. Improved diagnostic evaluation of suspected tuberculosis. Ann Intern Med. 2008. 148:325–336.
23. Pai M, Dheda K, Cunningham J, Scano F, O'Brien R. T-cell assays for the diagnosis of latent tuberculosis infection: moving the research agenda forward. Lancet Infect Dis. 2007. 7:428–438.
24. Mazurek GH, Jereb J, Lobue P, Iademarco MF, Metchock B, Vernon A. Guidelines for using the Quanti-FERON-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR Recomm Rep. 2005. 54:49–55.
25. Kim SH, Song KH, Choi SJ, Kim HB, Kim NJ, Oh MD, et al. Diagnostic usefulness of a T-cell-based assay for extrapulmonary tuberculosis in immunocompromised patients. Am J Med. 2009. 122:189–195.
26. Golden MP, Vikram HR. Extrapulmonary tuberculosis: an overview. Am Fam Physician. 2005. 72:1761–1768.
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