Yonsei Med J.  2019 Apr;60(4):375-380. 10.3349/ymj.2019.60.4.375.

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

• Hur YG
• Hong JY
• Choi DH
• Kim A
• Park SY
• Kwon M
• Kang K
• Lee JM
• Dockrell H
• Lee Y
• Joo H
• Cho SN

• KMID: 2450193
• DOI: http://doi.org/10.3349/ymj.2019.60.4.375

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 ichromaâ„¢ 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.

Keyword

ichroma™ IGRA-TB; IFN-γ; latent TB infection; point-of-care platform; QuantiFERON-TB Gold In-Tube test; tuberculosis

MeSH Terms

Diagnosis*
Enzyme-Linked Immunosorbent Assay
Feasibility Studies*
Healthy Volunteers
Humans
Korea*
Latent Tuberculosis*
Methods
Mycobacterium tuberculosis
Point-of-Care Systems*
ROC Curve
Tuberculosis

Figure

• 

  Fig. 1 Diagnostic value of the ichroma™ IGRA-TB test in identifying M. tb infection. The IFN-γ responses measured by ichroma™ IGRA-TB cartridges distinguished infected individuals with an AUC of 0.9706 (95% CI, 0.92–1.00, p<0.001) in ROC curve analysis (p<0.001). IGRA, IFN-γ release assay; TB, tuberculosis; CI, confidence interval; AUC, area under the curve; ROC, receiver operating characteristic.

• 

  Fig. 2 Association of IFN-γ release between two different assays. The association of the IFN-γ responses between the QFT-GIT and ichroma™ IGRA-TB tests was analyzed by Spearman's correlation coefficient. The graph shows a very strong positive correlation of IFN-γ values between the two tests (r=0.91, p<0.001). QFT-GIT, QuantiFERON-TB Gold In-Tube; IGRA, IFN-γ release assay; TB, tuberculosis.

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