Performance evaluation of a new automated chemiluminescent immunoanalyzer-based interferon-gamma releasing assay advansure I3 in comparison with the QuantiFERON-TB Gold In-tube assay

Jin Ju Kim, Younhee Park, Dasom Choi, Hyon Suk Kim

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2 Citations (Scopus)

Abstract

Background: The interferon-gamma (IFN-γ) releasing assay (IGRA) is widely used for latent tuberculosis infection (LTBI) diagnosis. We evaluated the analytical performance of a new automated chemiluminescent immunoanalyzer-based IGRA (CLIA-IGRA), AdvanSure I3 (LG Life Sciences, Seoul, Korea) and compared it with that of the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay. Methods: Repeatability and reproducibility were evaluated at four levels. Detection capability, including limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ), was evaluated using IFN-γ standard material (National Institute for Biological Standards and Control code: 87/586). Agreement between the results of two assays was evaluated using 341 blood samples from healthcare workers and patients at a tertiary care hospital. To determine the cut-off value of CLIA-IGRA for diagnosing LTBI, the ROC curve was analyzed. Results: Repeatability and reproducibility were 4.86-7.00% and 6.36-7.88% CV, respectively. LoB, LoD, and LoQ were 0.022, 0.077, and 0.249 IU/mL, respectively. IFN-γ values between CLIA-IGRA and QFT-GIT showed a strong correlation within the analytical measurable range of both assays, especially when the value was low. Qualitative comparison of the two assays yielded a 99.1% overall agreement (kappa coefficient=0.98). A cut-off value of 0.35 IU/mL was appropriate for diagnosing LTBI. Conclusions: CLIA-IGRA is a reliable assay for LTBI diagnosis, with performance similar to that of QFT-GIT.

Original languageEnglish
Pages (from-to)33-39
Number of pages7
JournalAnnals of laboratory medicine
Volume40
Issue number1
DOIs
Publication statusPublished - 2020

Bibliographical note

Publisher Copyright:
© Korean Society for Laboratory Medicine This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

All Science Journal Classification (ASJC) codes

  • Clinical Biochemistry
  • Biochemistry, medical

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