A Feasibility Study for Diagnosis of Latent Tuberculosis Infection Using an IGRA Point-of-Care Platform in South Korea
10.3349/ymj.2019.60.4.375
- Author:
Yun Gyoung HUR
1
;
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
Author Information
1. Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seoul, Korea. hur1225@gmail.com
- Publication Type:Original Article
- Keywords:
ichroma™ IGRA-TB;
IFN-γ;
latent TB infection;
point-of-care platform;
QuantiFERON-TB Gold In-Tube test;
tuberculosis
- MeSH:
Diagnosis;
Enzyme-Linked Immunosorbent Assay;
Feasibility Studies;
Healthy Volunteers;
Humans;
Korea;
Latent Tuberculosis;
Methods;
Mycobacterium tuberculosis;
Point-of-Care Systems;
ROC Curve;
Tuberculosis
- From:Yonsei Medical Journal
2019;60(4):375-380
- CountryRepublic of Korea
- Language:English
-
Abstract:
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℃, 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.