Are interferon-γ release assays useful for diagnosing active tuberculosis in a high-burden setting?

Eur Respir J. 2011 Sep;38(3):649-56. doi: 10.1183/09031936.00181610. Epub 2011 Feb 24.

Abstract

Although interferon-γ release assays (IGRAs) are intended for diagnosing latent tuberculosis (TB), we hypothesised that in a high-burden setting: 1) the magnitude of the response when using IGRAs can distinguish active TB from other diagnoses; 2) IGRAs may aid in the diagnosis of smear-negative TB; and 3) IGRAs could be useful as rule-out tests for active TB. We evaluated the accuracy of two IGRAs (QuantiFERON®-TB Gold In-tube (QFT-GIT) and T-SPOT®.TB) in 395 patients (27% HIV-infected) with suspected TB in Cape Town, South Africa. IGRA sensitivity and specificity (95% CI) were 76% (68-83%) and 42% (36-49%) for QFT-GIT and 84% (77-90%) and 47% (40-53%) for T-SPOT®.TB, respectively. Although interferon-γ responses were significantly higher in the TB versus non-TB groups (p<0.0001), varying the cut-offs did not improve discriminatory ability. In culture-negative patients, depending on whether those with clinically diagnosed TB were included or excluded from the analysis, the negative predictive value (NPV) of QFT-GIT, T-SPOT®.TB and chest radiograph in smear-negative patients varied between 85 and 89, 87 and 92, and 98% (for chest radiograph), respectively. Overall accuracy was independent of HIV status and CD4 count. In a high-burden setting, IGRAs alone do not have value as rule-in or -out tests for active TB. In smear-negative patients, chest radiography had better NPV even in HIV-infected patients.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cohort Studies
  • Female
  • HIV Infections / complications
  • Humans
  • Interferon-gamma / metabolism*
  • Interferon-gamma Release Tests / methods
  • Interferon-gamma Release Tests / standards*
  • Male
  • Middle Aged
  • Mycobacterium tuberculosis / metabolism
  • Predictive Value of Tests
  • Primary Health Care / methods
  • Radiography, Thoracic / methods
  • Reproducibility of Results
  • Sensitivity and Specificity
  • South Africa
  • Tuberculin Test / methods
  • Tuberculosis / diagnosis*
  • Tuberculosis / metabolism

Substances

  • Interferon-gamma