Sensitivity and specificity of QuantiFERON-TB Gold Plus compared with QuantiFERON-TB Gold In-Tube and T-SPOT.TB on active tuberculosis in Japan

The QuantiFERON-TB Gold Plus (QFT-Plus) was introduced in 2015 as a new generation of interferon-gamma release assays (IGRAs) designed to detect Mycobacterium tuberculosis infection (TB). Examination of its diagnostic accuracy is crucial before it is launched in Japan. We examined 99 patients with l...

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Bibliographic Details
Published in:Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy 2018-03, Vol.24 (3), p.188-192
Main Authors: Takasaki, Jin, Manabe, Toshie, Morino, Eriko, Muto, Yoshikazu, Hashimoto, Masao, Iikura, Motoyasu, Izumi, Shinyu, Sugiyama, Haruhito, Kudo, Koichiro
Format: Article
Language:English
Subjects:
Adult
Confidence Intervals
Female
Humans
IGRA
Interferon-gamma - blood
Interferon-gamma Release Tests - methods
Japan - epidemiology
Male
QFT
Sensitivity
Sensitivity and Specificity
Specificity
T-SPOT
Tertiary Care Centers
Tuberculosis
Tuberculosis - diagnosis
Tuberculosis - epidemiology
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Summary:The QuantiFERON-TB Gold Plus (QFT-Plus) was introduced in 2015 as a new generation of interferon-gamma release assays (IGRAs) designed to detect Mycobacterium tuberculosis infection (TB). Examination of its diagnostic accuracy is crucial before it is launched in Japan. We examined 99 patients with laboratory-confirmed active TB (patients) and 117 healthy volunteers with no risk of TB infection (controls) at a medical center in Tokyo, Japan. Blood samples were collected from both the patients and controls and tested using three types of IGRAs: the QFT-Plus, the QuantiFERON-TB Gold In-Tube (QFT-GIT), and the T-SPOT.TB (T-SPOT). The sensitivity and specificity of each IGRA were examined and compared. The sensitivity of the QFT-Plus was 98.9% (95% confidence interval [CI], 0.934–0.998) and similar to that of the QFT-GIT (97.9%; 95% CI, 0.929–0.998) and T-SPOT (96.9%; 95% CI, 0.914–0.994). The specificity of the QFT-Plus was the same as that of the QFT-GIT and T-SPOT (98.1%; 95% CI, 0.934–0.998). One patient with uncontrolled diabetes mellitus showed negative results on all three IGRAs. The QFT-Plus showed a high degree of agreement with the QFT-GIT and T-SPOT, with high sensitivity and specificity. Severe diabetes mellitus may influence the results of IGRAs. Larger studies are needed to validate the accuracy of the GFT-Plus and determine whether it can contribute as adjunctive method for the early diagnosis of active TB in Japan.
ISSN:1341-321X
1437-7780
DOI:10.1016/j.jiac.2017.10.009