Ann Lab Med 2020; 40(1): 33-39  https://doi.org/10.3343/alm.2020.40.1.33
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, M.D., Younhee Park, M.D., Ph.D., Dasom Choi, M.T., and Hyon-Suk Kim, M.D., Ph.D.
Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
Corresponding author: Hyon-Suk Kim, M.D., Ph.D.
Department of Laboratory Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea
Tel: +82-2-2228-2443 Fax: +82-2-313-0956 E-mail: kimhs54@yuhs.ac
Received: January 8, 2019; Revised: April 18, 2019; Accepted: July 24, 2019; Published online: January 1, 2020.
© Korean Society for Laboratory Medicine. All rights reserved.

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.
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.
Keywords: Performance, Interferon-γ releasing assay, Latent tuberculosis infection, Chemiluminescent immunoanalyzer, QuantiFERON-TB Gold In‑Tube



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