Sensitivity and characteristics associated with positive QuantiFERON-TB Gold-Plus assay in children with confirmed tuberculosis

Nguyen, Duc T.; Phan, Ha; Trinh, Thang; Nguyen, Hieu V.; Doan, Ha Thi-Ngoc; Pham, Nam; Nguyen, Hung Van; Nguyen, Hanh; Le, Hoi Van; Nguyen, Nhung Viet; Graviss, Edward A.

doi:10.1371/journal.pone.0213304

Cited by 14 publications

(27 citation statements)

References 31 publications

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“…This rate is much smaller than what has been reported from previous studies on QFT-IT (8, 18-21) but similar to the overall percentage of indeterminate results (4%) described in a recent metanalysis about IGRAs other than QFT-Plus (22). Importantly, Nguyen et al reported that only 2/222 children evaluated with QFT-Plus had indeterminate results, confirming our finding that QFT-Plus is also effective in children and can be a good alternative to TST (16). Among the 5 children with indeterminate results, 4/5 had comorbidities and only one child was otherwise healthy when screened for LTBI.…”

Section: Discussionsupporting

confidence: 90%

“…The overall sensitivity of QFT-Plus for active TB was 83.3% and specificity was 90.1%. These rates are similar to what have been reported from previous studies on QFT-IT (8) but higher compared with rates of the only extensive pediatric study published so far on QFT-Plus that reported an overall sensitivity of 54.5% (16). Nevertheless, sensitivity raised to 84.2% when they exclusively evaluated pulmonary TB.…”

Section: Discussionsupporting

confidence: 89%

“…In our study, we found that TB1 and TB2 responses had a 100% concordance. In the single available study evaluating TB1/TB2 concordance in the pediatric population, among 45 positive QFT-Plus results, 37 were identified by both TB1 and TB2, 7 were identified by TB2 only, and 1 was identified by TB1 only; the TB1/TB2 agreement was 96.4% (95% confidence interval [CI], 93.9 to 98.9%) (16). According to the manufacturer instructions, QFT-Plus is considered positive when either TB1 or TB2 IFN-␥ values (IU/ml) reach the assay cutoff.…”

Section: Discussionmentioning

confidence: 99%

“…While QFT-Plus has already been evaluated in adults, there are not enough data in children evaluated for suspected TB infection (16). In this scenario, we performed this study aiming to evaluate the accuracy of the QFT-Plus assay in children with suspected active TB/LTBI.…”

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confidence: 99%

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

et al. 2020

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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.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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

et al. 2020

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“…A recent longitudinal study in a high TB prevalence setting suggests that IGRAs are less sensitive than TSTs for the detection of LTBI [24]. The updated version of the QFT assay, QuantiFERON-TB Gold Plus, may perform better, but the available data in children currently remain limited [25], [26], [27].…”

Section: Introductionmentioning

confidence: 99%

Mycobacterium tuberculosis-specific cytokine biomarkers for the diagnosis of childhood TB in a TB-endemic setting

Sudbury

Otero

Tebruegge

et al. 2019

Journal of Clinical Tuberculosis and Other Mycobacterial Diseas

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The tuberculin skin test and interferon-gamma release assays have limitations in diagnosing tuberculosis (TB), particularly in children. This study investigated the performance of candidate M. tuberculosis-specific cytokine biomarkers for TB in children in a TB-endemic setting. A total of 237 children with a household contact with smear-positive pulmonary TB were recruited. Importantly, a group of children with illnesses other than TB (sick controls) was included to assess specificity.Median IFN-ɣ, IL-1ra, IL-2, IL-13, IP-10, MIP-1β and TNF-α responses were significantly higher in children with active TB and latent TB infection (LTBI) than in both healthy and sick control children. Three of these cytokines – IL-2, IL-13 and IP-10 – showed better performance characteristics than IFN-ɣ, with IL-2 achieving positive and negative predictive values of 97.7% and 90.7%, respectively. Furthermore, IL-1ra and TNF-α responses differed significantly between active TB and LTBI cases, suggesting that they may be stage-specific biomarkers.Our data indicate that incorporating these biomarkers into future blood-based TB assays could result in substantial performance gains.

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Commercially available CD4 + and CD8 + IFN-γ release assays combined with an HBHA-induced IGRA improve the characterization of the tuberculosis spectrum and monitoring of treatment in children

et al. 2023

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Commercially available Interferon-γ release assays (IGRAs), including the last-generation QuantiFERON TB-Plus (QFT-Plus), are effective in aiding the diagnosis of tuberculosis (TB) infection but cannot distinguish latent TB subjects from active TB patients. The aim of this study was to prospectively evaluate the performance of an HBHA-based IGRA, combined with commercially available IGRAs, to assess their usefulness as a prognostic biomarkers and aid in the monitoring of TB treatment in children. Following clinical, microbiological, and radiological assessment, children younger than 18 years of age classified as either LTBI or active TB were tested at baseline and during treatment by the QuantiFERON TB-Plus (QFT) assay and an aliquot of whole-blood was stimulated with HBHA. Among the 655 children evaluated, 559 (85.3%) were classified as “Non TB”, 44 patients (6.7%) with active TB, and 52 (7.9%) with LTBI. The median HBHA-IGRA IFN-gamma responses were able to discriminate active TB from LTBI (0.13 IU/ml vs 1.995, (p < 0,0001), those with asymptomatic TB from those with symptomatic TB (1.01 IU/ml vs 0.115 IU/ml, p 0.017), or more severe TB (p 0.022), and significantly raised during successful TB treatment (p < 0.0001). Conversely, CD4 + and CD8 + responses were similar in all groups of patients, although active TB patients had higher CD4 + responses and LTBI higher CD8 + responses. Conclusion: HBHA-based IGRA, combined with CD4 + and CD8 + responses assessed by commercially available IGRAs, is a useful support in the characterization of the TB spectrum in children and monitoring of TB-therapy. What is Known:• Current immune diagnostics are not able to discriminate active and latent Ttuberculosis, including the recently approved QFT-PLUS..• New immunological assays with prognostic value are highly needed. What is New:• HBHA-based IGRA, combined with CD4+ and CD8+ responses assessed by commercially available IGRAs, is a useful support for the differentiation of active and latent TB in children..• HBHA-based IGRA, combined with CD4+ and CD8+ responses assessed by commercially available IGRAs, is a useful support in the monitoring of TBtherapy in children..

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Sensitivity and characteristics associated with positive QuantiFERON-TB Gold-Plus assay in children with confirmed tuberculosis

Cited by 14 publications

References 31 publications

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

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

Mycobacterium tuberculosis-specific cytokine biomarkers for the diagnosis of childhood TB in a TB-endemic setting

Commercially available CD4 + and CD8 + IFN-γ release assays combined with an HBHA-induced IGRA improve the characterization of the tuberculosis spectrum and monitoring of treatment in children

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