Department of Laboratory Medicine, Korea University College of Medicine, Seoul 02841, Republic of Korea.
Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Yangsan 50612, Republic of Korea.
Medicina (Kaunas). 2023 Sep 27;59(10):1734. doi: 10.3390/medicina59101734.
: This study aimed to evaluate the performance of a new chemiluminescent immunoassay-based tuberculosis (TB) interferon-gamma release assay (IGRA), AdvanSureI3 TB-IGRA (LG Chem Ltd., Seoul, Republic of Korea), for detecting latent tuberculosis infection in comparison with T-SPOT. (Oxford Immunotec, Oxford, UK). : Between June 2021 and December 2021, 125 non-duplicate blood specimens were collected from adult volunteers; each subject received both tests concurrently. Total agreement and Cohen's kappa coefficient (κ) were used to calculate concordance. The Jonckheere-Terpstra test was used to examine the correlation between interferon-gamma (IFN-γ) levels in AdvanSureI3 TB-IGRA and spot counts in T-SPOT.. : The IGRA findings of the two assays revealed 90.8% (95% confidence interval [CI] = 84.2-94.8) total agreement with κ of 0.740 (95% CI = 0.595-0.885), showing substantial agreement between the two tests. Additionally, the amount of IFN-γ in AdvanSureI3 TB-IGRA increased with the spot counts in T-SPOT. ( < 0.001). : Our research revealed that the results of the AdvanSureI3 TB-IGRA were comparable to those of T-SPOT..
这项研究旨在评估一种新的基于化学发光免疫分析的结核（TB）干扰素-γ释放测定（IGRA），AdvanSureI3 TB-IGRA（LG Chem Ltd.，韩国首尔），用于检测潜伏性结核感染，与 T-SPOT.（Oxford Immunotec，英国牛津）进行比较。
在 2021 年 6 月至 2021 年 12 月期间，从成年志愿者中收集了 125 份非重复的血液样本；每位受试者同时接受了这两种检测。总一致性和 Cohen's kappa 系数（κ）用于计算一致性。Jonckheere-Terpstra 检验用于检查 AdvanSureI3 TB-IGRA 中干扰素-γ（IFN-γ）水平与 T-SPOT.中的斑点计数之间的相关性。
两种检测方法的 IGRA 结果显示，总一致性为 90.8%（95%置信区间 [CI] = 84.2-94.8），κ值为 0.740（95% CI = 0.595-0.885），表明两种检测方法之间具有高度一致性。此外，AdvanSureI3 TB-IGRA 中的 IFN-γ含量随着 T-SPOT.中的斑点计数增加而增加（<0.001）。
我们的研究表明，AdvanSureI3 TB-IGRA 的结果与 T-SPOT.的结果相当。
