Diagnostic accuracy and predictive value of the QuantiFERON-TB gold plus assay for tuberculosis in immunocompromised individuals: a prospective TBnet study.
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Sester Martina, Altet-Gomez Neus, Andersen Åse Bengaard, Arias-Guillén Miguel, Avsar Korkut, Bakken Kran Anne-Marte, Bothamley Graham, Nordholm Breschel Anne Christine, Brown James, Chesov Dumitru, Ciobanu Nelly, Cirillo Daniela Maria, Crudu Valeriu, de Souza Galvao Malu, Dilektasli Asli Görek, Dominguez José, Duarte Raquel, Dyrhol-Riise Anne Ma, Goletti Delia, Hoffmann Harald, Ibraim Elmira, Kalsdorf Barbara, Krawczyk Marcin, Kunst Heinke, Lange Berit, Lipman Marc, Matteelli Alberto, Milkiewicz Piotr, Neyer David, Nitschke Martin, Oral Haluk Barbaros, Palacios-Gutiérrez Juan José, Petruccioli Elisa, Raszeja-Wyszomirska Joanna, Ravn Pernille, Rupp Jan, Spohn Hanna-Elisa, Toader Corina, Villar-Hernandez Raquel, Wagner Dirk, van Leth Frank, Martinez Leonardo, Pedersen Ole Skouvig, Lange Christoph
Аннотация
METHODS: In this prospective observational study, immunocompromised adults ≥18 years of age including people living with HIV (PLHIV), chronic renal failure, rheumatoid arthritis, solid-organ transplantation or stem-cell transplantation, and immunocompetent adults with and without TB-disease were recruited at 21 sites in 11 European countries and tested with the QFT+ assay. Individuals without TB-disease were followed up for the development of tuberculosis. TB incidence rates (IR) were calculated, stratified by QFT+ results and acceptance of TPT. This study is registered with Clinicaltrials.gov, NCT02639936.
FINDINGS: A total of 2663 individuals (1115 female, 1548 male) were enrolled from 03/11/2015 to 29/03/2019. Persons without tuberculosis were followed up for at least two years. Among 1758 immunocompromised individuals without active tuberculosis, 13.6% had positive QFT+ results. Sensitivity and specificity for TB-disease were 70.0% (52.1-83.3%) and 91.4% (89.6-92.9%), respectively, in immunocompromised, and 81.4% (76.6-85.3%) and 96.0% (92.5-97.9%), respectively, in immunocompetent individuals. During 2457 cumulative years of follow-up among 932 individuals with chronic renal failure, rheumatoid arthritis, solid-organ transplantation or stem-cell transplantation, including 83 persons with a positive QFT+ test without TPT, no-one developed active tuberculosis. In contrast, among 642 PLHIV without TPT, one with an indeterminate QFT+ and 3/30 individuals with a positive QFT+ developed active tuberculosis; all had detectable HIV-replication and low CD4 T-cell counts (incidence 4.1 (95% CI (1.3-12.4) per 100 person-years). No individuals receiving TPT developed active tuberculosis during 269 years of follow-up.
INTERPRETATION: In immunocompromised individuals in low TB-endemic countries, the 2-year-risk for active tuberculosis was highest among PLHIV with detectable HIV-replication and low CD4-counts. In this study, the QFT+ assay did not strongly predict progression to active tuberculosis, which emphasises the need to incorporate additional risk factors.
FUNDING: None.