Fluctuating Behavior and Influential Factors in the Performance of the QuantiFERON-TB Gold In-Tube Assay in the Diagnosis of Tuberculosis

PLoS One. 2015 Aug 19;10(8):e0103763. doi: 10.1371/journal.pone.0103763. eCollection 2015.

Abstract

Background: The QuantiFERON-TB Gold In-Tube (QFT-GIT) is a newly developed but widely used interferon-γ release assay for diagnosing tuberculosis (TB). However, research has not determined whether age or the use of an immune suppressive or anti-TB treatment influences this assay's ability to detect TB. We assessed the QFT-GIT diagnostic performance for active tuberculosis (ATB) in children and adults in an endemic country and explored the effects of glucocorticoids and anti-TB therapy on the diagnostic value of the QFT-GIT.

Methods: A total of 60 children and 212 adults with suspected ATB were evaluated with the QFT-GIT. The association between the QFT-GIT diagnostic value and pretreatment factors was qualitatively and quantitatively assessed.

Results: The sensitivity of the QFT-GIT was 83.9% (95% CI 66.3%-94.6%) in children, and 73.7% (95% CI 57.8%-85.2%) in adults. Glucocorticoids affected the mitogen-stimulated response in both children and adults. In subjects undergoing glucocorticoid pretreatment, 25.0% of the children presented with false-negative QFT-GIT results, 28.6% of adults presented with indeterminate results. For subjects pre-treated with anti-TB drugs, 44.4% presented with false-negative QFT-GIT results.

Conclusions: The QFT-GIT has higher sensitivity and specificity in children than adults. Glucocorticoid treatment negatively impacts the diagnostic value of the QFT-GIT in all age groups. Anti-TB treatment decreases the sensitivity of the QFT-GIT. Therefore, we recommend that the QFT-GIT assay be performed before TB-specific treatment is initiated and the test should not be used on people undergoing immunosuppression treatment, regardless of their age. A quantitative analysis of the QFT-GIT could be useful for assessing and monitoring TB-specific and non-specific immunity during conversion of the disease.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biological Assay / methods*
  • Child, Preschool
  • False Negative Reactions
  • Female
  • Glucocorticoids / chemistry
  • Gold / immunology*
  • Humans
  • Immunity, Innate / immunology
  • Interferon-gamma Release Tests / methods*
  • Male
  • Middle Aged
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Tuberculin Test / methods*
  • Tuberculosis / diagnosis*

Substances

  • Glucocorticoids
  • Reagent Kits, Diagnostic
  • Gold

Grants and funding

This study was supported by a research grant from The National Natural Science Foundation (30901277). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.