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

E D Pieterman; F G Liqui Lung; A Verbon; H I Bax; C W Ang; J Berkhout; G Blaauw; A Brandenburg; N D van Burgel; A Claessen; K van Dijk; M Heron; M Hooghiemstra; R Leussenkamp-Hummelink; E van Lochem; I H M van Loo; B Mulder; A Ott; O Pontesilli; A Reuwer; P Rombouts; V Saegeman; M Scholing; S Vainio; J E M de Steenwinkel

doi:10.1016/j.tube.2017.11.014

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.

Authors

E D Pieterman¹, F G Liqui Lung², A Verbon³, H I Bax⁴, C W Ang⁵, J Berkhout⁶, G Blaauw⁷, A Brandenburg⁸, N D van Burgel⁹, A Claessen¹⁰, K van Dijk⁵, M Heron¹¹, M Hooghiemstra⁸, R Leussenkamp-Hummelink¹², E van Lochem¹³, I H M van Loo¹⁴, B Mulder¹², A Ott¹⁵, O Pontesilli¹⁶, A Reuwer¹¹, P Rombouts¹⁷, V Saegeman¹⁸, M Scholing¹⁹, S Vainio¹⁰, J E M de Steenwinkel²

Affiliations

¹ Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, The Netherlands. Electronic address: e.pieterman@erasmusmc.nl.
² Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, The Netherlands.
³ Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, The Netherlands; Department of Internal Medicine, Section of Infectious Diseases, Erasmus University Medical Centre, Rotterdam, The Netherlands.
⁴ Department of Internal Medicine, Section of Infectious Diseases, Erasmus University Medical Centre, Rotterdam, The Netherlands.
⁵ Department of Medical Microbiology and Infection Control, VU Medical Centre, Amsterdam, The Netherlands.
⁶ Department of Medical Microbiology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
⁷ Department of Medical Microbiology, Gelre Hospital, Apeldoorn, The Netherlands.
⁸ Izore Centre for Infectious Diseases Friesland, Leeuwarden, The Netherlands.
⁹ Department of Medical Microbiology, HAGA Hospital, Den Haag, The Netherlands.
¹⁰ Department of Medical Microbiology and Immunology, St. Antonius Hospital, Nieuwegein, The Netherlands.
¹¹ Department of Medical Microbiology and Immunology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.
¹² Labmicta, Hengelo, The Netherlands.
¹³ Department of Medical Microbiology and Immunology, Rijnstate Hospital, Arnhem, The Netherlands; Department of Clinical Chemistry, Gelderse Vallei Hospital, Ede, The Netherlands.
¹⁴ Department of Medical Microbiology, Maastricht University Medical Centre, Maastricht, The Netherlands.
¹⁵ Department of Medical Microbiology, Certe, Groningen, The Netherlands.
¹⁶ Department of Medical Microbiology, Maasstad Hospital, Rotterdam, The Netherlands.
¹⁷ Department of Medical Microbiology and Infectious Diseases, Ikazia Hospital, Rotterdam, The Netherlands.
¹⁸ Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology and Immunology, K.U. Leuven, Leuven, Belgium.
¹⁹ Department of Medical Microbiology, OLVG, Amsterdam, The Netherlands; Public Health Laboratory, Amsterdam, The Netherlands.

PMID: 29523314
DOI: 10.1016/j.tube.2017.11.014

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