新自动化化学发光免疫分析试剂盒（AdvanSure I3）检测γ干扰素释放试验与 QuantiFERON-TB Gold In-Tube 检测试剂盒的性能评估比较。
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.
机构信息
Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
出版信息
Ann Lab Med. 2020 Jan;40(1):33-39. doi: 10.3343/alm.2020.40.1.33.
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.
背景
干扰素-γ（IFN-γ）释放测定（IGRA）广泛用于潜伏性结核感染（LTBI）的诊断。我们评估了一种新的基于自动化化学发光免疫分析的 IGRA（CLIA-IGRA），AdvanSure I3（LG Life Sciences，首尔，韩国）的分析性能，并将其与 QuantiFERON-TB Gold In-Tube（QFT-GIT）检测进行了比较。
方法
在四个水平上评估重复性和再现性。使用 IFN-γ 标准物质（国家生物标准与控制研究所代码：87/586）评估检测能力，包括空白限（LoB）、检测限（LoD）和定量限（LoQ）。使用三级保健医院医护人员和患者的 341 份血样评估两种检测方法结果的一致性。为了确定 CLIA-IGRA 诊断 LTBI 的截断值，进行了 ROC 曲线分析。
结果
重复性和再现性分别为 4.86-7.00%和 6.36-7.88%CV。LoB、LoD 和 LoQ 分别为 0.022、0.077 和 0.249 IU/mL。在两种检测方法的分析可测量范围内，CLIA-IGRA 和 QFT-GIT 的 IFN-γ 值之间显示出很强的相关性，尤其是低值时。两种检测方法的定性比较显示总符合率为 99.1%（kappa 系数=0.98）。0.35 IU/mL 的截断值适合诊断 LTBI。
结论
CLIA-IGRA 是一种可靠的 LTBI 诊断检测方法，其性能与 QFT-GIT 相似。
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