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

Abstract

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.

QuantiFERON-TB Gold PLUS versus QuantiFERON- TB Gold In-Tube test for diagnosing tuberculosis infection

“…However, in our study, there was no significant difference in the proportion of TB2 antigen response (TB2-TB1 difference of > 0.6 IU/ mL) between the two groups, nor was there a significant difference in the median IFN-γ release of TB2-TB1 between the groups. This finding contradicts that of a previous study of the Netherlands and Belgium [19], and could be explained as follows. First, QFT-PLUS as well as QFT-GIT, doesn't have capability to distinguish between recent TB infection and remote TB infection.…”

“…Most previous studies comparing the performances of the QFT-PLUS and QFT-GIT tests were performed in European countries with a low TB burden and showed comparable results for diagnosing TB infection [19,21,22,26]. Our study provides further evidence that the QFT-PLUS and QFT-GIT are highly comparable based on the results of agreement, Cohen's κ, and ICC between the tests even in a TB endemic country.…”

“…A previous study showed that CD8+ T-cells were frequently detected in individuals with active TB compared to those with LTBI, which correlates to a high TB burden [16]. Furthermore, other studies showed that higher IFN-γ release in TB2 compared with TB1 was associated with recent TB infection [19,22]. The high-risk TB infection group has a greater chance of recent infection than the low-risk group.…”

“…The QFT-PLUS contains two antigen tubes, TB1 and TB2: the TB1 tube contains ESAT-6-and CFP-10-derived peptides (TB 7.7 was removed) and is designed to induce CD4+ T cells response; the TB2 contains both the same long peptides of TB1 and newly designed peptides that stimulate IFN-γ production by both CD4+ and CD8+ T cells [18]. Recent studies have reported similar accuracies of QFT-PLUS and with QFT-GIT [17,[19][20][21][22], and some showed higher CD8+ T cell responses to recent Mtb exposure compared to remote exposure in contact screening [19,22].…”

Evaluation of the QuantiFERON-Tuberculosis Gold Plus Assay in Children with Tuberculosis Disease or Following Household Exposure to Tuberculosis

“…It was designed to increase the sensitivity for detecting the immune response to TB in subpopulations such as children, people living with HIV (PLHIV), and recently infected individuals. Thus far it has demonstrated similar performance characteristics to the QFT-GIT, among adults, [7][8][9][10][11] with limited data in subpopulations and some suggestion of benefit in PLHIV, recently infected individuals, and those with severe TB disease. 8,[12][13][14][15] Here, we evaluate the performance of the QFT-Plus compared with that of the QFT-GIT in a critical subpopulation of children with household exposure to TB disease and in those treated for TB disease.…”