The Preliminary Application of Whole Blood Interferon-Gamma Release Assay Combined with T Lymphocyte Subset Detection in Diagnosis of Pulmonary Tuberculosis
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摘要:
目的 探讨全血γ-干扰素释放试验(Interferon-gamma release assay,IGRA)联合T淋巴细胞亚群检测在肺结核诊断中的价值。 方法 纳入2015年9月至2016年2月在中国人民解放军联勤保障部队第九二〇医院感染科住院诊断为肺结核的全部患者58例,其中痰涂阳活动性肺结核或肺穿刺活检组织学确诊为肺结核患者41例,痰涂阴性而临床诊断为肺结核(且经临床抗结核治疗有效)的肺结核患者17例。同时选择中国人民解放军联勤保障部队第九二〇医院同期健康体检的自愿者48例作为对照组。所有受试者进行全血IGRA检测、T淋巴细胞亚群检测。 结果 IGRA检查诊断肺结核的灵敏度为86.2%(50 / 58),特异度为95.8%(46 /48),漏诊率为13.8%(8 / 58),误诊率为4.2%(2/ 48),ROC曲线下面积AUC = 0.816(P = 0.001)。治疗前肺结核组患者CD3(+)、CD4(+)及CD4(+)/CD8(+)较正常组明显下降,CD8(+)较正常组明显升高,并与正常组比较差异均具有统计学意义(P < 0.05)。IGRA检查联合T淋巴细胞亚群检测诊断肺结核的灵敏度为96.6%(56/ 58),特异度为91.7%(44/ 48),漏诊率为3.4%(2/ 58),误诊率为8.3%(4/48),IGRA实验联合T淋巴细胞亚群检测ROC曲线下面积AUC = 0.911(P < 0.001)。 结论 IGRA检查联合T淋巴细胞亚群检测诊断肺结核具有较高灵敏度和特异性,漏诊率较单一IGRA检测明显降低,具有较高诊断价值,值得临床推广。 Abstract:Objective To evaluate the clinical application value of whole blood interferon-gamma release assay (IGRA) combined with T lymphocyte subset detection in diagnosis of pulmonary tuberculosis (TB). Methods A total of 58 consecutive patients diagnosed with pulmonary tuberculosis who were hospitalized in our hospital from September 2015 to February 2016 in our hospital were enrolled, including 41 patients with sputum-coated positive pulmonary tuberculosis or confirmed as the pulmonary tuberculosis by pulmonary fine needle aspiration biopsy, and 17 patients with sputum-coated negative and clinically diagnosed as the pulmonary tuberculosis by effective anti-tuberculosis treatment. 48 healthy volunteers were randomly selected in our hospital as the control group. All subjects underwent blood γ- interferon release assay, and T lymphocyte subsets test. Results The sensitivity of IGRA diagnosis of tuberculosis was 86.2% (50/58), the specificity was 95.8% (46/48), the underdiagnosis rate was 13.8% (8/58), and the misdiagnosis rate was 4.2% (2/48), and the area under the ROC curve (AUC) was 0.816 (P = 0.001). CD3+, CD4+ and CD4+/CD8+ were significantly decreased and CD8+ was significantly increased in the TB group at the baseline, and the differences were statistically significant compared with the control group (P < 0.05). The sensitivity of IGRA combined with T lymphocyte subsets detection for the diagnosis of tuberculosis was 96.6% (56/58), the specificity was 91.7% (44/48), the underdiagnosis rate was 3.4% (2/58) and the misdiagnosis rate was 8.3% (4/48). The AUC of IGRA test combined with T lymphocyte subsets detection was 0.911 (P < 0.001). Conclusion The IGRA combined with T lymphocyte subsets test has the high sensitivity and specificity in the diagnosis of the pulmonary tuberculosis, and the rate of missed diagnosis is significantly lower than that of single IGRA test, which has the high diagnostic value and is worthy of clinical promotion. -
表 1 受试者基线资料 [
$\bar x \pm s$ /n(%)]Table 1. Baseline characteristics of subjects [
$\bar x \pm s$ /n(%)]类别 肺结核组(n = 58) 健康对照组(n = 48) t χ2 P 性别n(%) 男 39(67.2) 30(62.5) \ 0.260 0.610 女 19(32.8) 18(37.5) 年龄($\bar x$ ± s)(岁) 38 ± 15.8 40 ± 10.1 最大年龄 70 68 0.564 \ 0.575 最小年龄 19 19 痰涂阳性肺结核n(%) 41(70.7) \ 轻度肺结核 15(36.6) 中度肺结核 8(19.5) 重度肺结核 18(43.9) \ 0.054 0.973 痰涂阴性肺结核n(%) 17(29.3) \ 轻度肺结核 6(.3) 中度肺结核 3(17.7) 重度肺结核 8(47) IGRA n(%) 阳性 50(86.2) 2(4.2) 70.73 < 0.001* 阴性 8(13.8) 46(95.8) T淋巴细胞表达率 CD3(+) 63.1 ± 7.6 70.5 ± 8 3.796 \ < 0.001* CD4(+) 29.6 ± 8.5 37.4 ± 5.3 4.142 \ < 0.001* CD8(+) 28.1 ± 5.1 24.4 ± 3.7 3.158 \ 0.002* CD4(+)/CD8(+) 1.3 ± 0.3 1.6 ± 0.4 3.966 \ < 0.001* *P < 0.05。 表 2 肺结核组和对照组IGRA结果 n(%)
Table 2. Results of IGRA in TB group and control group n(%)
分组 肺结核组 对照组 合计 χ21 P1 χ22 P2 痰涂阳性1 痰涂阴性2 IGRA(+) 33(80.5) 15(88.2) 2(4.2) 50 53.981 < 0.001* 45.939 < 0.001* IGRA(−) 8(19.5) 2(11.8) 46(95.8) 56 合计 41 17 48 106 注:。χ21 为痰涂阳性组与对照组比较,χ22 为痰涂阴性组与对照组比较;*表示P < 0.05。 表 3 IGRA检测肺结核的四格表(n)
Table 3. The 2 × 2 table of IGRA detection of pulmonary tuberculosis (n)
项目 肺结核 合计 + − IGRA + 50 2 52 − 8 46 54 合计 58 48 106 注:联合试验指IGRA联合T淋巴细胞亚群检测。 表 4 联合试验检测肺结核的四格表(n)
Table 4. The 2 × 2 table of IGRA combined with T lymphocyte subset detection of pulmonary tuberculosis (n)
项目 肺结核 合计 + − 联合试验 + 56 4 52 − 2 44 54 合计 58 48 106 注:联合试验指IGRA联合T淋巴细胞亚群检测。 -
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