Accuracy of QuantiFERON-TB Gold Plus Test for Diagnosis of Mycobacterium tuberculosis Infection in Children

Abstract

Compared to its predecessor QuantiFERON-TB Gold In Tube (QFT-IT), QuantiFERON-TB Gold Plus (QFT-Plus) contains an additional antigen tube (TB2), stimulating both CD4+ and CD8+ T cells. The ability to discriminate CD4+ and CD8+ responses is suggested to be useful in differentiating stages of Mycobacterium tuberculosis infection. While QFT-Plus has already been evaluated in adults, there are not enough data in children evaluated for suspected active tuberculosis (TB) or latent TB infection (LTBI). A prospective cross-sectional study was conducted among children aged 0 to 17 years who were evaluated for suspected active TB or screened for LTBI. All children underwent QFT-Plus and further clinical, radiological, and/or microbiological analyses according to clinical scenario. Of the 198 children enrolled, 43 (21.7%) were tested because of suspicion of active TB. A total of 12/43 (27.9%) were diagnosed with active TB, and among these, 10/12 (83.3%) had a positive QFT-Plus assay. Of the 155 children screened for LTBI, 18 (11.6%) had a positive QFT-Plus, and 5 (2.5%) had an indeterminate result. TB1 and TB2 quantitative responses were not able to discriminate active disease from latent infection. The percent agreement between TB1 and TB2 was 100%. QFT-Plus assay showed good sensitivity for active TB and was particularly useful for the evaluation of children with suspected LTBI, giving a low rate of indeterminate results in this group. More studies are needed to properly evaluate QFT-Plus ability in discriminating active disease from latent infection.

Retrospective Performance Analyses of over Two Million U.S. QuantiFERON Blood Sample Results

“…Other clinical studies, however, showed no significant difference in the proportion of positive results between TB1 and TB2 tubes ( 23 ). Fifteen clinical studies comparing QFT-Plus to QFT-GIT were recently reviewed ( 24 ).…”

Clinical evaluation of QuantiFERON®-TB Gold Plus directly compared with QuantiFERON®-TB Gold In-Tube and T-Spot®.TB for active pulmonary tuberculosis in the elderly

“…They had no history of human immunodeficiency virus infection. It is worth noting that the QFT-Plus test, in addition to being highly sensitive in detecting active TB in the elderly and in immunocompromised subjects, also displayed good sensitivity in identifying TBI in children, whose immune systems are not fully mature [30,31]. Unlike other IGRAs, QFT-Plus quantifies the immune response mediated by both CD4 and CD8 T cells following M. tuberculosis antigenic induction.…”

Comparison of pediatric empyema secondary to tuberculosis or non‐tuberculosis community‐acquired pneumonia in those who underwent surgery in high TB burden areas

“…One of the shortages was neither TST nor IGRAs can effectively discriminate active TB from latent TB infection 46 . Recently, research showed that QuantiFERON‐TB Gold Plus Test showed good sensitivity for active TB and was particularly useful for the evaluation of children with suspected latent TB infection 47 …”