Bellagha Rahma, Dhaouadi Tarak, Riahi Awatef, Ben Rehouma Wahiba, Jedidi Hajer, Mouelhi Leila, Abdelmoula Leila, Ben Abdallah Taïeb, Gorgi Yousr, Sfar Imen
Research Laboratory in Immunology of Renal Transplantation and Immunopathology (LR03SP01), Charles Nicolle Hospital, Tunis El Manar University, Tunis, Tunisia.
Department of Gastro-Enterology, Charles Nicolle Hospital, Tunis, Tunisia.
SAGE Open Med. 2024 Sep 9;12:20503121241279116. doi: 10.1177/20503121241279116. eCollection 2024.
Screening for latent tuberculosis infection using Interferon-Gamma Release Assays is a routine procedure prior to the initiation of anti-tumor necrosis factor (TNF) biotherapy or immunosuppressive therapy. However, indeterminate results are relatively frequent and are an obstacle to treatment initiation.
The aim of this cross-sectional study was to estimate the frequency of indeterminate QuantiFERON-TB Gold Plus test results in Tunisian patients, and to analyze the potential clinico-biological risk factors associated with these indeterminate results.
Whole blood samples from 712 patients being monitored for autoimmune diseases and candidates for anti-TNF biotherapy or switch of immunosuppressive therapy were used to screen for latent tuberculosis infection using the QuantiFERON-TB Gold Plus test. Based on literature background, the following variables were tested for the association with indeterminate results: gender, age, diabetes, immunosuppressive drugs, lymphocyte count, Neutrophil-to-lymphocyte ratio, serum albumin, and estimated glomerular filtration rate.
The QuantiFERON-TB Gold Plus test was negative in 572 (80.3%) patients, positive in 106 (14.9%), and indeterminate in 34 (4.8%) cases. Positive results were significantly associated with a family history of confirmed and treated tuberculosis, OR (95% CI) = 52 (20.2-134.3). The use of immunosuppressive drugs and duration of treatment were significantly associated with the occurrence of indeterminate results: OR (95% CI) = 24.5 (5.8-103) and OR (95% CI) = 1.004 (1.002-1.007), respectively. Biologically, lymphopenia, hypoalbuminemia, and decreased estimated glomerular filtration rate were significant risk factors for indeterminate results: = 5 E-6, = 4.3 E-4, and = 0.002, respectively. Thus, a multiple logistic regression model based on these three biological parameters enabled us to develop a predictive score for indeterminate results with a sensitivity of 91.2% and a specificity of 99.9%, AUC = 0.9964 (0.9917-1), = 2.8 E-52.
Immunosuppressive therapy, lymphopenia, hypoalbuminemia, and kidney failure appeared to be risk factors for indeterminate QuantiFERON-TB Gold Plus results.
在开始使用抗肿瘤坏死因子（TNF）生物疗法或免疫抑制疗法之前，使用干扰素-γ释放试验筛查潜伏性结核感染是一项常规程序。然而，不确定结果相对常见，是治疗开始的一个障碍。
这项横断面研究的目的是估计突尼斯患者中QuantiFERON-TB Gold Plus试验不确定结果的频率，并分析与这些不确定结果相关的潜在临床生物学危险因素。
使用QuantiFERON-TB Gold Plus试验对712名正在接受自身免疫性疾病监测且为抗TNF生物疗法或免疫抑制疗法转换候选者的患者的全血样本进行潜伏性结核感染筛查。基于文献背景，对以下变量进行与不确定结果的相关性测试：性别、年龄、糖尿病、免疫抑制药物、淋巴细胞计数、中性粒细胞与淋巴细胞比值、血清白蛋白和估计肾小球滤过率。
QuantiFERON-TB Gold Plus试验在572名（80.3%）患者中为阴性，106名（14.9%）为阳性，34名（4.8%）为不确定结果。阳性结果与确诊并接受治疗的结核病家族史显著相关，比值比（95%可信区间）=52（20.2-134.3）。免疫抑制药物的使用和治疗持续时间与不确定结果的发生显著相关：比值比（95%可信区间）分别为24.5（5.8-103）和1.004（1.002-1.007）。从生物学角度来看，淋巴细胞减少、低白蛋白血症和估计肾小球滤过率降低是不确定结果的显著危险因素：分别为5×10⁻⁶、4.3×10⁻⁴和0.002。因此，基于这三个生物学参数的多元逻辑回归模型使我们能够开发出一种不确定结果的预测评分，敏感性为91.2%，特异性为99.9%，曲线下面积=0.9964（0.9917-1），P=2.8×10⁻⁵²。
免疫抑制疗法、淋巴细胞减少、低白蛋白血症和肾衰竭似乎是QuantiFERON-TB Gold Plus结果不确定的危险因素。
