A Feasibility Study for Diagnosis of Latent Tuberculosis Infection Using an IGRA Point-of-Care Platform in South Korea
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Purpose: This study aimed to evaluate ichromaTM IGRA-TB, a novel point-of-care platform for assaying IFN-γ release, and to compareit 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 responseswere assessed by the ichromaTM IGRA-TB cartridge and the QFT-GIT IFN-γ enzyme-linked immunosorbent assay. Three activeTB patients were recruited as a positive control for M. tb infection. Results: The area under the receiver operating characteristic curve of the ichromaTM IGRA-TB test for differentiating between infectedand non-infected individuals was 0.9706 (p<0.001). Inconsistent positivity between the two tests was found in three participantswho 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 ichromaTM IGRA-TB test could be used as arapid diagnostic method for detecting latent TB infection. It may be particularly beneficial in resource-limited places that requirecost-effective laboratory diagnostics.
Abstract
Purpose: This study aimed to evaluate ichromaTM IGRA-TB, a novel point-of-care platform for assaying IFN-γ release, and to compareit 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 responseswere assessed by the ichromaTM IGRA-TB cartridge and the QFT-GIT IFN-γ enzyme-linked immunosorbent assay. Three activeTB patients were recruited as a positive control for M. tb infection. Results: The area under the receiver operating characteristic curve of the ichromaTM IGRA-TB test for differentiating between infectedand non-infected individuals was 0.9706 (p<0.001). Inconsistent positivity between the two tests was found in three participantswho 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 ichromaTM IGRA-TB test could be used as arapid diagnostic method for detecting latent TB infection. It may be particularly beneficial in resource-limited places that requirecost-effective laboratory diagnostics.
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