Elsevier

The Journal of Pediatrics

Volume 223, August 2020, Pages 212-215.e1
The Journal of Pediatrics

Brief Report
Diagnostic Accuracy of QuantiFERON-TB Gold Plus Assays in Children and Adolescents with Tuberculosis Disease

https://doi.org/10.1016/j.jpeds.2020.02.025Get rights and content

In 2016, a new interferon-gamma release assay, QuantiFERON-TB Gold Plus, was introduced. We conducted a cross-sectional multicenter study, involving 158 children and adolescents with tuberculosis disease. The overall sensitivity of the assay was 82.9% (IQR 77.0%-88.8%), indicating that in children this test does not have higher sensitivity than previous generation interferon-gamma release assays.

Section snippets

Methods

We performed a cross-sectional study within the Spanish Pediatric TB Research Network (pTBred),7 which includes 83 participating centers. Patients <18 years of age diagnosed with TB are eligible for inclusion in the pTBred database. Data are collected using Research Electronic Data Capture electronic data capture tools, hosted at Instituto de Investigación Sanitaria Gregorio Marañón. Approval for pTBred was obtained from the Hospital Carlos III Madrid Ethics Committee (ref.P13/12). Informed

Results

During the study period, 168 children diagnosed with TB disease were included in the pTBred database; 158 had QFT-Plus results: 131 were positive (82.9%), 25 negative (15.8%), and 2 indeterminate (1.3%, both because of insufficient mitogen responses) (Table I). The median age was 5.3 (IQR 2.4-11.6) years. Most patients had been born in Spain (73.4%) and were BCG-unvaccinated (73.4%). Nine (5.7%) had significant comorbidities: Down syndrome (n = 3), malnutrition (n = 2) and acute lymphoblastic

Discussion

This large study on the performance of QFT-Plus assays in children and adolescents with TB disease showed sensitivity of QFT-Plus assay of 82.9%, highlighting that approximately 1 in 5 children with TB have a false-negative test result when this assay is used as an adjunctive test. Importantly, this shows that in the context of TB disease, the new generation assay does not perform better than previous generation QFT assays, which had a pooled sensitivity of 83% in a well-designed meta-analysis

Data Statement

Data sharing statement available at www.jpeds.com.

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Supported by “Subvencions per a la Intensificació de Facultatius Especialistes” (Departament de Salut de la Generalitat de Catalunya, Programa PERIS 2016-2020) (SLT008/18/00193 [to A.N-J.]). M.T. has received QuantiFERON assays at reduced pricing or free of charge for TB diagnostics projects from the manufacturer (Cellestis/Qiagen) in the past, and has received support for conference attendance from Cepheid. The manufacturers had no influence on the study design, data collection, analysis or interpretation, writing of the manuscript or decision to submit the data for publication. The other authors declare no conflicts of interest.

Contributed equally.

List of additional members of the QFT-Plus Study Group of the Spanish Pediatric TB Research Network is available at www.jpeds.com (Appendix).

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