Hur Yun Gyoung, Hong Ji Young, Choi Dong Hwan, Kim Ahreum, Park So Yeong, Kwon Minsuk, Kang Kyungjoon, Lee Jeong Min, Dockrell Hazel M, Lee Yoonsuk, Joo Hoodon, Cho Sang Nae
Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seoul, Korea.
Department of Pulmonary and Critical Care Medicine, Hallym University Medical Center, Chuncheon, Korea.
Yonsei Med J. 2019 Apr;60(4):375-380. doi: 10.3349/ymj.2019.60.4.375.
This study aimed to evaluate ichroma™ IGRA-TB, a novel point-of-care platform for assaying IFN-γ release, and to compare it with QuantiFERON-TB Gold In-Tube (QFT-GIT) for identifying () infection.
We recruited 60 healthy subjects, and blood samples were obtained in QFT-GIT blood collection tubes. The blood collection tubes were incubated at 37°C, and culture supernatant was harvested after 18-24 hours. IFN-γ responses were assessed by the ichroma™ IGRA-TB cartridge and the QFT-GIT IFN-γ enzyme-linked immunosorbent assay. Three active TB patients were recruited as a positive control for infection.
The area under the receiver operating characteristic curve of the ichroma™ IGRA-TB test for differentiating between infected and non-infected individuals was 0.9706 (<0.001). Inconsistent positivity between the two tests was found in three participants who showed weak positive IFN-γ responses (<1.0 IU/mL) with QFT-GIT. However, the two tests had excellent agreement (95.2%, κ=0.91, <0.001), and a very strong positive correlation was observed between the IFN-γ values of both tests (r=0.91, <0.001).
The diagnostic accuracy demonstrated in this study indicates that the ichroma™ IGRA-TB test could be used as a rapid diagnostic method for detecting latent TB infection. It may be particularly beneficial in resource-limited places that require cost-effective laboratory diagnostics.
本研究旨在评估ichroma™IGRA - TB，一种用于检测干扰素 - γ释放的新型即时检测平台，并将其与管内定量干扰素 - γ释放试验（QFT - GIT）进行比较，以识别（）感染。
我们招募了60名健康受试者，并使用QFT - GIT采血管采集血样。将采血管在37°C下孵育，18 - 24小时后收集培养上清液。通过ichroma™IGRA - TB检测卡和QFT - GIT干扰素 - γ酶联免疫吸附测定法评估干扰素 - γ反应。招募了3名活动性结核病患者作为（）感染的阳性对照。
ichroma™IGRA - TB检测用于区分感染和未感染个体的受试者工作特征曲线下面积为0.9706（<0.001）。在3名QFT - GIT检测显示干扰素 - γ反应弱阳性（<1.0 IU/mL）的参与者中，发现两种检测结果的阳性不一致。然而，两种检测具有极好的一致性（95.2%，κ = 0.91，<0.001），并且两种检测的干扰素 - γ值之间观察到非常强的正相关（r = 0.91，<0.001）。
本研究中证明的诊断准确性表明，ichroma™IGRA - TB检测可作为检测潜伏性结核感染的快速诊断方法。在需要经济高效的实验室诊断的资源有限地区，它可能特别有益。
