D J Horne1, B E Jones2, A Kamada3, K Fukushima4, K L Winthrop5, S A R Siegel6, A Kovacs7, P Anthony7, K A Meekin7, S Bhat2, P Kerndt8, A Chang8, D M Koelle9, M Narita10. 1. Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Department of Global Health, Firland Northwest TB Center, University of Washington, Seattle, Washington. 2. Division of Infectious Diseases, Department of Medicine, University of Southern California, Los Angeles, California, USA. 3. National Hospital Organization Hokkaido Medical Center, Sapporo. 4. Division of Respiratory Medicine, Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, Nagasaki, Japan. 5. Division of Infectious Diseases, Department of Medicine, Oregon Health & Science University, Portland, School of Public Health, Oregon Health & Science University, Portland State University, Portland, Oregon. 6. School of Public Health, Oregon Health & Science University, Portland State University, Portland, Oregon. 7. Maternal, Child, and Adolescent Virology Research Laboratory, University of Southern California, Los Angeles. 8. TB Control Program, Los Angeles County Department of Public Health, Los Angeles, California. 9. Department of Global Health, Division of Allergy and Infectious Diseases, Department of Medicine, Department of Laboratory Medicine, University of Washington, Seattle, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Benaroya Research Institute, Seattle. 10. Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Department of Global Health, Firland Northwest TB Center, University of Washington, Seattle, Washington, Benaroya Research Institute, Seattle.
Abstract
SETTING: QuantiFERON®-TB Gold Plus (QFT-Plus), recently approved for use in the United States, is a new-generation QuantiFERON assay that differs from its predecessors in that it uses an additional antigen tube containing peptides to elicit both CD8+ and CD4+ T-lymphocyte responses. OBJECTIVE: To assess the sensitivity of QFT-Plus compared with QuantiFERON®-TB Gold In-Tube (QFT-GIT) in participants with active TB. DESIGN: Adult patients with active TB at three US and two Japanese sites were eligible for this study if they had culture-confirmed TB and were either untreated or had received 14 days of anti-tuberculosis treatment. RESULTS: We enrolled 164 participants, nine of whom had indeterminate results. Excluding indeterminate values, there were 150 QFT-GIT-positive results among 159 tests and 146 QFT-Plus-positive results among 157 tests, with sensitivities of respectively 94.3% (95%CI 89.5-97.4) and 93.02% (95%CI 87.8-96.5%). The estimated sensitivities for the two tests were not significantly different (P = 0.16). Overall test agreement was 98.7%, with a κ statistic of 0.89 (95%CI 0.75-1.00). CONCLUSION: In this multisite study, we found that QFT-Plus had similar sensitivity to QFT-GIT in adult patients with active TB.
SETTING: QuantiFERON®-TB Gold Plus (QFT-Plus), recently approved for use in the United States, is a new-generation QuantiFERON assay that differs from its predecessors in that it uses an additional antigen tube containing peptides to elicit both CD8+ and CD4+ T-lymphocyte responses. OBJECTIVE: To assess the sensitivity of QFT-Plus compared with QuantiFERON®-TB Gold In-Tube (QFT-GIT) in participants with active TB. DESIGN: Adult patients with active TB at three US and two Japanese sites were eligible for this study if they had culture-confirmed TB and were either untreated or had received 14 days of anti-tuberculosis treatment. RESULTS: We enrolled 164 participants, nine of whom had indeterminate results. Excluding indeterminate values, there were 150 QFT-GIT-positive results among 159 tests and 146 QFT-Plus-positive results among 157 tests, with sensitivities of respectively 94.3% (95%CI 89.5-97.4) and 93.02% (95%CI 87.8-96.5%). The estimated sensitivities for the two tests were not significantly different (P = 0.16). Overall test agreement was 98.7%, with a κ statistic of 0.89 (95%CI 0.75-1.00). CONCLUSION: In this multisite study, we found that QFT-Plus had similar sensitivity to QFT-GIT in adult patients with active TB.
Authors: Duc T Nguyen; Ha Phan; Trang Trinh; Hang Nguyen; Ha Doan; Nam Pham; Hung Nguyen; Hanh Nguyen; Hung V Nguyen; Hoi V Le; Nhung Nguyen; Edward A Graviss Journal: PLoS One Date: 2019-03-04 Impact factor: 3.240