Line Lindebo Holm1, Michala Vaaben Rose2, Godfather Kimaro3, Ib C Bygbjerg4, Sayoki G Mfinanga3, Pernille Ravn5, Morten Ruhwald6. 1. Clinical Research Centre, and Departments of Paediatrics and line.lindebo.holm@gmail.com. 2. Infectious Diseases, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark; 3. Muhimbili Medical Research Centre, National Institute for Medical Research, Dar es Salaam, Tanzania; 4. Department of International Health, Immunology and Microbiology, University of Copenhagen, Copenhagen, Denmark; 5. Clinical Research Centre, and Department for Pulmonary and Infectious Diseases, Nordsjaelland Hospital, Hillerød, Denmark; and. 6. Department of Infectious Disease Immunology, Statens Serum Institute, Copenhagen, Denmark.
Abstract
OBJECTIVE: Interferon-γ and IP-10 release assays are diagnostic tests for tuberculosis infection. We have compared the accuracy of IP-10 and QuantiFERON-TB Gold In-tube [QFT-IT] in Tanzanian children suspected of having active tuberculosis (TB). METHODS: Hospitalized Tanzanian children with symptoms of TB were tested with the QFT-IT and IP-10 tests and retrospectively classified into diagnostic groups. Adults with confirmed TB were assessed in parallel. RESULTS: A total of 203 children were included. The median age was 3.0 years (interquartile range: 1.2-7.0), 38% were HIV infected, 36% were aged <2 years, and 58% had a low weight-for-age. IP-10 and QFT-IT test performance was comparable but sensitivity was low: 33% (1 of 3) in children with confirmed TB and 29% (8 of 28) in children with probable TB. Rates of indeterminate responders were high: 29% (59 of 203) for IP-10 and 26% (53 of 203) for QFT-IT. Age <2 years was associated with indeterminate test outcome for both IP-10 (adjusted odds ratio [aOR]: 2.2; P = .02) and QFT-IT (aOR: 2.4; P = .01). TB exposure was associated with positive IP-10 test outcome (aOR: 3.6; P = .01) but not with positive QFT-IT outcome (aOR 1.4; P = .52). In 102 adults, test sensitivity was 80% for both tests (P = .248). CONCLUSIONS: Although IP-10 and QFT-IT performed well in Tanzanian adults, the tests exhibited an equally poor performance in diagnosing active TB in children. Test performance was especially compromised in young children. Neither test can be recommended for use in hospitalized children in high-burden settings.
OBJECTIVE: Interferon-γ and IP-10 release assays are diagnostic tests for tuberculosis infection. We have compared the accuracy of IP-10 and QuantiFERON-TB Gold In-tube [QFT-IT] in Tanzanian children suspected of having active tuberculosis (TB). METHODS: Hospitalized Tanzanian children with symptoms of TB were tested with the QFT-IT and IP-10 tests and retrospectively classified into diagnostic groups. Adults with confirmed TB were assessed in parallel. RESULTS: A total of 203 children were included. The median age was 3.0 years (interquartile range: 1.2-7.0), 38% were HIV infected, 36% were aged <2 years, and 58% had a low weight-for-age. IP-10 and QFT-IT test performance was comparable but sensitivity was low: 33% (1 of 3) in children with confirmed TB and 29% (8 of 28) in children with probable TB. Rates of indeterminate responders were high: 29% (59 of 203) for IP-10 and 26% (53 of 203) for QFT-IT. Age <2 years was associated with indeterminate test outcome for both IP-10 (adjusted odds ratio [aOR]: 2.2; P = .02) and QFT-IT (aOR: 2.4; P = .01). TB exposure was associated with positive IP-10 test outcome (aOR: 3.6; P = .01) but not with positive QFT-IT outcome (aOR 1.4; P = .52). In 102 adults, test sensitivity was 80% for both tests (P = .248). CONCLUSIONS: Although IP-10 and QFT-IT performed well in Tanzanian adults, the tests exhibited an equally poor performance in diagnosing active TB in children. Test performance was especially compromised in young children. Neither test can be recommended for use in hospitalized children in high-burden settings.
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