Purpose: 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 Mycobacterium tuberculosis (M. tb) infection. Materials and Methods: We recruited 60 healthy subjects, and blood samples were obtained in QFT-GIT blood collection tubes. The blood collection tubes were incubated at 37ºC, 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 M. tb infection. Results: 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 (p<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, p<0.001), and a very strong positive correlation was observed between the IFN-γ values of both tests (r=0.91, p<0.001). Conclusion: 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.
|Number of pages||6|
|Journal||Yonsei medical journal|
|Publication status||Published - 2019 Apr|
Bibliographical noteFunding Information:
Med Inc., Chuncheon, and in part by funding from the Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seoul, South Korea. Sang-Nae Cho received a research grant from Boditech Med Inc., but claims no conflict of interest. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
This work was supported by a research grant from Boditech
© Yonsei University College of Medicine 2019.
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