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A Feasibility Study for Diagnosis of Latent Tuberculosis Infection Using an IGRA Point-of-Care Platform in South Korea

 Yun-Gyoung Hur  ;  Ji Young Hong  ;  Dong Hwan Choi  ;  Ahreum Kim  ;  So-yeong Park  ;  Minsuk Kwon  ;  Kyungjoon Kang  ;  Jeong-Min Lee  ;  Hazel M. Dockrell  ;  Yoonsuk Lee  ;  Hoodon Joo  ;  Sang-Nae Cho 
 YONSEI MEDICAL JOURNAL, Vol.60(4) : 375-380, 2019 
Journal Title
Issue Date
Adult ; Area Under Curve ; Case-Control Studies ; Enzyme-Linked Immunosorbent Assay/methods* ; Feasibility Studies ; Female ; Humans ; Interferon-gamma/analysis ; Interferon-gamma/blood* ; Interferon-gamma Release Tests/methods* ; Latent Tuberculosis/diagnosis* ; Latent Tuberculosis/ethnology ; Latent Tuberculosis/immunology ; Male ; Mycobacterium tuberculosis/immunology ; Mycobacterium tuberculosis/isolation & purification* ; Point-of-Care Systems* ; ROC Curve ; Reagent Kits, Diagnostic ; Republic of Korea/epidemiology ; Tuberculin Test/methods* ; Young Adult
IFN-γ ; QuantiFERON-TB Gold In-Tube test ; latent TB infection ; point-of-care platform ; tuberculosis ; ichroma™ IGRA-TB
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 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 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.
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1. College of Medicine (의과대학) > Dept. of Microbiology (미생물학교실) > 1. Journal Papers
Yonsei Authors
Cho, Sang Nae(조상래)
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