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J Clin Microbiol. 2019 Aug 28. pii: JCM.00985-19. doi: 10.1128/JCM.00985-19. [Epub ahead of print]

Comparing QuantiFERON-TB Gold Plus with other tests to diagnose Mycobacterium tuberculosis infection.

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Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA
Northrop Grumman, Atlanta, GA, USA.
Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Denver Health and Hospital Authority, Denver, CO, USA.
Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
Department of Pathology and Genomic Medicine, Houston Methodist Research Institute, Houston, TX, USA.


The fourth generation QuantiFERON test for tuberculosis infection, QuantiFERON-TB Gold Plus (QFT-Plus) has replaced the earlier version, QuantiFERON-TB Gold In-Tube (QFT-GIT). A clinical need exists for information about agreement between QFT-Plus and other tests.We conducted this study to assess agreement of test results for QFT-Plus with those of QuantiFERON-TB Gold In-Tube (QFT-GIT), T-SPOT.TB (T-SPOT) and the tuberculin skin test (TST).Persons at high risk of LTBI and/or progression to TB disease were enrolled at the 10 sites of the Tuberculosis Epidemiologic Studies Consortium from October 2016 through May 2017; each participant received all four tests. Cohen's kappa (κ) and Wilcoxon signed rank test compared qualitative and quantitative results of QFT-Plus with the other tests.Test results for 506 participants showed 94% agreement between QFT-Plus and QFT-GIT, with 19% positive and 75% negative results. When the tests disagreed, it was most often in the direction of QFT-GIT negative/QFT-Plus positive. QFT-Plus had similar concordance as QFT-GIT with TST (77% and 77%) and T-SPOT (92% and 91%), respectively.Conclusions: The study showed high agreement between QFT-GIT and QFT-Plus in a direct comparison. Both tests had similar agreement with TST and T-SPOT.


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