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KMID : 1100720200400010033
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Annals of Laboratory Medicine
2020 Volume.40 No. 1 p.33 ~ p.39
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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
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Kim Jin-Ju
Park Youn-Hee
Choi Da-Som
Kim Hyon-Suk
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Abstract
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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.
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KEYWORD
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Performance, Interferon-γ releasing assay, Latent tuberculosis infection, Chemiluminescent immunoanalyzer, QuantiFERON-TB Gold In-Tube
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