Takasaki Jin, Manabe Toshie, Morino Eriko, Muto Yoshikazu, Hashimoto Masao, Iikura Motoyasu, Izumi Shinyu, Sugiyama Haruhito, Kudo Koichiro
Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.
J Infect Chemother. 2018 Mar;24(3):188-192. doi: 10.1016/j.jiac.2017.10.009. Epub 2017 Nov 3.
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.
QuantiFERON-TB Gold Plus（QFT-Plus）于2015年推出，是新一代用于检测结核分枝杆菌感染（TB）的干扰素-γ释放试验（IGRAs）。在日本推出之前，对其诊断准确性进行检查至关重要。
我们在日本东京的一家医疗中心对99例实验室确诊的活动性结核病患者（患者组）和117名无结核感染风险的健康志愿者（对照组）进行了检查。从患者组和对照组采集血样，并使用三种类型的IGRAs进行检测：QFT-Plus、QuantiFERON-TB Gold In-Tube（QFT-GIT）和T-SPOT.TB（T-SPOT）。检查并比较了每种IGRA的敏感性和特异性。
QFT-Plus的敏感性为98.9%（95%置信区间[CI]，0.934 - 0.998），与QFT-GIT（97.9%；95% CI，0.929 - 0.998）和T-SPOT（96.9%；95% CI，0.914 - 0.994）相似。QFT-Plus的特异性与QFT-GIT和T-SPOT相同（98.1%；95% CI，0.934 - 0.998）。一名未控制的糖尿病患者在所有三种IGRAs检测中均呈阴性结果。
QFT-Plus与QFT-GIT和T-SPOT高度一致，具有高敏感性和特异性。严重糖尿病可能影响IGRAs的检测结果。需要进行更大规模的研究来验证QFT-Plus的准确性，并确定它是否能作为日本活动性结核病早期诊断的辅助方法。
