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

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  • Additional Information
    • Source:
      Publisher: Yonsei University Country of Publication: Korea (South) NLM ID: 0414003 Publication Model: Print Cited Medium: Internet ISSN: 1976-2437 (Electronic) Linking ISSN: 05135796 NLM ISO Abbreviation: Yonsei Med J Subsets: MEDLINE
    • Publication Information:
      Original Publication: Seoul : Yonsei University
    • Subject Terms:
      Point-of-Care Systems*; Enzyme-Linked Immunosorbent Assay/*methods ; Interferon-gamma/*blood ; Interferon-gamma Release Tests/*methods ; Latent Tuberculosis/*diagnosis ; Mycobacterium tuberculosis/*isolation & purification ; Tuberculin Test/*methods; Adult ; Area Under Curve ; Case-Control Studies ; Feasibility Studies ; Female ; Humans ; Interferon-gamma/analysis ; Latent Tuberculosis/ethnology ; Latent Tuberculosis/immunology ; Male ; Mycobacterium tuberculosis/immunology ; ROC Curve ; Reagent Kits, Diagnostic ; Republic of Korea/epidemiology ; Young Adult
    • 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°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.
      Competing Interests: The authors have no potential conflicts of interest to disclose.
      (© Copyright: Yonsei University College of Medicine 2019.)
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    • Grant Information:
      International Boditech Med Inc.; International YUCM
    • Contributed Indexing:
      Keywords: IFN-γ; QuantiFERON-TB Gold In-Tube test; latent TB infection; point-of-care platform; tuberculosis; ichroma™ IGRA-TB
    • Accession Number:
      0 (Reagent Kits, Diagnostic)
      82115-62-6 (Interferon-gamma)
    • Publication Date:
      Date Created: 20190323 Date Completed: 20190509 Latest Revision: 20200309
    • Publication Date:
      20221213
    • Accession Number:
      PMC6433574
    • Accession Number:
      10.3349/ymj.2019.60.4.375
    • Accession Number:
      30900424