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

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  • 1 Baylor College of Medicine, Houston, Texas;
  • | 2 Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, Texas;
  • | 3 Ministry of Health, Mbabane, Eswatini
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Interferon-gamma release assays are increasingly used in children to establish evidence of tuberculosis (TB) infection and to assist in the diagnosis of TB disease. The QuantiFERON-TB Gold In-Tube assay is being phased out in favor of a next-generation test, the QuantiFERON-TB Gold Plus (QFT-Plus) assay. The QFT-Plus assay is designed with two antigen tubes to differentially stimulate CD4+ and CD8+ T cells. The performance of this assay has been documented extensively in adults but has not yet been evaluated in children. Here, we compare the performance of the two assays in a cohort of 46 children exposed to TB and 12 children diagnosed with TB disease in Eswatini. The tests demonstrated excellent concordance in both TB disease (100% agreement, Cohen’s kappa = 1) and TB infection (96% agreement, Cohen’s kappa = 0.91). Most of the children with household exposure tested negative for TB infection by both tests, indicating the ongoing need for new tests for TB infection that can be easily implemented in TB high-burden settings at minimal cost.

Author Notes

Address correspondence to Anna M. Mandalakas, Baylor College of Medicine, 1102 Bates St., FC-630, Houston, TX 77030. E-mail: anna.mandalakas@bcm.edu

Authors’ addresses: Alexander W. Kay, Baylor College of Medicine, Houston, TX, and Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, TX, E-mail: alexander.kay@bcm.edu. Andrew R. DiNardo, Pilar Ustero, and Anna M. Mandalakas, Baylor College of Medicine, Houston, TX, E-mails: andrew.dinardo@bcm.edu, pustero@yahoo.es, and anna.mandalakas@bcm.edu. Qiniso Dlamini, Jaqueline Kahari, Temhlanga Mndzebele, and Godwin Mtetwa, Baylor College of Medicine, Children’s Foundation-eSwatini, Houston, TX, E-mails: qinisod@baylorswaziland.org.sz, jaqkahari@gmail.com, m.temhlanga@gmail.com, and gmtetwa@baylorswaziland.org.sz. Gugu Maphalala, Eswatini Health Laboratory Services, Ministry of Health, Eswatini, E-mail: gpmaph@gmail.com.

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