A multicentre verification study of the QuantiFERON®-TB Gold Plus assay

Tuberculosis (Edinb). 2018 Jan:108:136-142. doi: 10.1016/j.tube.2017.11.014. Epub 2017 Nov 28.

Abstract

Objectives: The aim of this verification study was to compare the QuantiFERON®-TB Gold Plus (QFT-Plus) to the QuantiFERON®-TB Gold In Tube (QFT-GIT). The new QFT-Plus test contains an extra antigen tube which, according to the manufacturer additionally elicits a CD8+ T-cell response above the CD4+ T-cell response. We assessed the value of this tube in detecting recent latent tuberculosis infections.

Methods: Between May 2015 and December 2016, 1031 subjects underwent QFT-Plus and QFT-GIT test. Overall agreement between both tests and performance for different test indications and/or immune states was assessed. A difference of >0.6 IU/mL interferon-γ release between the two antigen tubes of the QFT-Plus assay was considered a true difference and used as estimation for CD8+ T-cell response.

Results: Analysis of the QuantiFERON tests resulted in an overall agreement between assays of 95%. Subjects considered to be recently exposed to tuberculosis had significantly more often a true difference in interferon-γ release compared to all other subjects (p = 0.029).

Conclusion: Results of QFT-Plus are highly comparable to QFT-GIT. Although there is an indication that a true difference in interferon-γ release between the antigen tubes is associated with recent latent tuberculosis infection, the QFT-Plus could not be used to exclude recent exposure.

Keywords: Interferon-gamma release assay; Latent tuberculosis infection; QuantiFERON-TB Gold In Tube; QuantiFERON-TB Gold Plus; Tuberculosis.

Publication types

  • Comparative Study
  • Multicenter Study
  • Validation Study

MeSH terms

  • Adult
  • Antigens, Bacterial / immunology*
  • Belgium
  • CD4-Positive T-Lymphocytes / immunology*
  • CD4-Positive T-Lymphocytes / metabolism
  • CD4-Positive T-Lymphocytes / microbiology
  • CD8-Positive T-Lymphocytes / immunology*
  • CD8-Positive T-Lymphocytes / metabolism
  • CD8-Positive T-Lymphocytes / microbiology
  • Female
  • Host-Pathogen Interactions
  • Humans
  • Interferon-gamma / immunology*
  • Interferon-gamma / metabolism
  • Interferon-gamma Release Tests*
  • Latent Tuberculosis / diagnosis*
  • Latent Tuberculosis / immunology
  • Latent Tuberculosis / microbiology
  • Male
  • Middle Aged
  • Mycobacterium tuberculosis / immunology*
  • Netherlands
  • Predictive Value of Tests
  • Reproducibility of Results

Substances

  • Antigens, Bacterial
  • IFNG protein, human
  • Interferon-gamma