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中华肺部疾病杂志(电子版)

中华肺部疾病杂志(电子版) ›› 2024, Vol. 17 ›› Issue (01) : 19 -24. doi: 10.3877/cma.j.issn.1674-6902.2024.01.004

论著

TSPOT.TB、Genechip、AFB及其联合应用在结核病中的诊断价值
熊欢庆1, 王惠琴2, 李玉娟3, 刘刚3, 金发光3,†()   
  1. 1. 712046　咸阳，陕西中医药大学
    2. 712099　咸阳，陕西中医药大学第二附属医院
    3. 710038　西安，空军军医大学唐都医院呼吸与危重症医学科
  • 收稿日期:2023-11-22 出版日期:2024-02-25
  • 通信作者: 金发光

Analysis of diagnostic efficacy of TSPOT.TB, Genechip, AFB, and their combined applications in tuberculosis

huanqing Xiong1, huiqin Wang2, yujuan Li3, gang Liu3, Faguang Jin3,†()   

  1. 1. Shanxi University of Chinese Medicine, Xianyang 712046, China
    2. The Second Affiliated Hospital of Shanxi University of Chinese Medicine, Xianyang 712099, China
    3. Department of Respiratory and Critical Care Medicine, The Second Affiliated Hospital of Air Force Medical University, Xi′an 710038, China
  • Received:2023-11-22 Published:2024-02-25
  • Corresponding author: Faguang Jin
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熊欢庆, 王惠琴, 李玉娟, 刘刚, 金发光. TSPOT.TB、Genechip、AFB及其联合应用在结核病中的诊断价值[J]. 中华肺部疾病杂志(电子版), 2024, 17(01): 19-24.

huanqing Xiong, huiqin Wang, yujuan Li, gang Liu, Faguang Jin. Analysis of diagnostic efficacy of TSPOT.TB, Genechip, AFB, and their combined applications in tuberculosis[J]. Chinese Journal of Lung Diseases(Electronic Edition), 2024, 17(01): 19-24.

目的

结核感染T细胞斑点实验(T cells spot test of tuberculosis infection, TSPOT.TB)与基因芯片(Genechip)是一种新型结核诊断检测方法，自2021年1月唐都医院开始常规应用TSPOT.TB、Genechip，评价诊断、分析联合诊断的可行性。

方法

回顾性选取2021年1月至2023年4月我院收治的256例住院患者，行T-SPOT.TB、Genechip、抗酸杆菌涂片镜检(acid-fast bacilli smear microscopy, AFB)，根据复合参考标准(compostie reference standard, CRS)考虑活动性结核病例。对三种检验方法进行比较和评价。

结果

256例患者同时接受T-SPOT.TB、Genechip法、AFB法检测，其中105例(41.02%)确诊为活动性结核病。>60岁141例(55.08%)，<60岁115例(44.92%)。>60岁患者，T-SPOT.TB法、AFB法、Genechip法检测结核的敏感性、特异性、AUC分别为：47.45%、82.93%、0.652；16.94%、98.78%、0.579；74.57%、98.78%、0.867；<60岁患者，分别为：44.65%、85.50%、0.656；10.86%、100.00%、0.554；73.91%、98.55%、0.862。联合检测中，>60岁患者，AFB＋Genechip法检验价值最高，敏感性、特异性、AUC为84.74%、97.56%、0.912。<60岁患者，T-SPOT.TB＋AFB＋Genechip联合诊断价值最高，敏感性、特异性、AUC分别为：100.00%、84.05%、0.920。

结论

Genechip检测具有高敏感性与高特异性，在结核病诊断中具有应用价值。TSPOT.TB、AFB、Genechip联合用于结核病的诊断率高，具有临床意义。

关键词: 结核病, 结核感染T细胞斑点实验, 基因芯片, 抗酸杆菌涂片镜检
Objective

The T cells spot test of tuberculosis infection(TSPOT.TB) and Genechip assays are new methods for the diagnosis and detection of tuberculosis (TB) infection. There is limited research on these methods in China. Since January 2021, the TSPOT.TB and Genechip assays have been routinely used at Tangdu Hospital. Therefore, the aim of this study was to investigate the efficacy of TSPOT.TB and Genechip assays and explore the feasibility of their combined diagnosis, providing reference and guidance for TB detection and diagnosis in non-TB comprehensive hospitals.

Methods

A retrospective study was conducted on 256 hospitalized patients admitted to Tangdu Hospital from January, 2021, to April, 2023. All patients underwent TSPOT.TB, Genechip, and acid-fast bacilli smear microscopy (AFB) tests. Active TB cases were considered based on a composite reference standard (CRS). The three diagnostic methods were compared and evaluated.

Results

A total of 256 patients underwent TSPOT.TB, Genechip, and AFB testing simultaneously. Among them, 105(41.02%) were diagnosed with active TB. with 141(55.08%) being over 60 years old and 105(44.92%) being under 60 years old. For patients over 60 years old, the sensitivity, specificity, and AUC of T-SPOT.TB, AFB, and Genechip assays for TB detection were as follows: 47.45%, 82.93%, 0.652; 16.94%, 98.78%, 0.579; 74.57%, 98.78%, 0.867. For patients under 60 years old, the sensitivity, specificity, and AUC of T-SPOT.TB, AFB, and Genechip assays for TB detection were as follows: 44.65%, 85.50%, 0.656; 10.86%, 100.00%, 0.554; 73.91%, 98.55%, 0.862. In combined testing, for patients over 60 years old, the AFB+ Genechip assay showed the highest diagnostic efficacy with sensitivity, specificity, and AUC of 84.74%, 97.56%, and 0.912, respectively. For patients under 60 years old, the T-SPOT.TB+ AFB+ Genechip combination had the highest diagnostic efficacy with sensitivity, specificity, and AUC of 100.00%, 84.05%, and 0.920, respectively.

Conclusion

The Genechip assay has high sensitivity and specificity and is highly valuable in TB diagnosis. However, the combined use of TSPOT.TB, AFB, and Genechip assays for TB diagnosis shows higher efficacy and can more effectively diagnose TB.

Key words: Tuberculosis, T cells spot test of tuberculosis infection, Genechip, Acid-fast bacilli smear microscopy
图1 265例患者诊断分类的流程图注：TSPOT.TB：结核感染T细胞斑点实验；Genechip：基因芯片；AFB：抗酸杆菌涂片镜检
表1 TSPOT.TB、AFB和Genechip的诊断价值比较(n＝256)
指标检测 敏感性(%)(95%CI) 特异性(%)(95%CI) 阳性预测值(%)(95%CI) 阴性预测值(%)(95%CI)
TSPOT.TB 46.22(36.56～56.22) 82.67(75.63～88.47) 65.30(55.61～73.83) 68.52(64.24～72.46)
AFB 14.15(8.12～22.34) 99.33(96.35～100.00) 93.76(66.73～99.17) 62.03(60.21～63.95)
Genechip 75.47(66.26～83.34) 99.33(96.35～100.00) 98.70(91.83～99.81) 85.11(80.42～88.86)
表2 T-SPOT.TB、AFB、Genechip联合诊断60岁以上之间的结果(n＝141)
指标单和/或叠加 灵敏度(%)(95%CI) 特异性(%)(95%CI) 阳性预测值(%)(95%CI) 阴性预测值(%)(95%CI)
TSPOT.TB 47.45(34.22～60.86) 82.93(73.01～90.33) 66.67(53.62～77.54) 68.60(62.85～74.01)
AFB 16.94(8.41～28.93) 98.78(93.31～99.90) 90.96(56.82～98.78) 62.33(59.51～65.07)
Genechip 74.57(61.51～85.03) 98.78(93.31～99.90) 97.76(86.14～99.68) 84.30(77.71～89.35)
TSPOT.TB＋AFB 52.54(39.10～65.76) 81.70(71.64～89.32) 67.31(55.10～77.63) 70.55(64.24～76.19)
AFB＋Genechip 84.74(73.02～92.76) 97.56(91.42～99.78) 96.15(86.30～98.91) 89.83(82.94～94.16)
TSPOT.TB＋Genechip 89.83(79.16～96.10) 82.92(73.01～90.33) 79.12(69.91～86.05) 91.88(84.03～96.04)
TSPOT.TB＋AFB Genechip 94.91(85.82～98.90) 81.71(71.63～89.31) 78.85(70.10～85.51) 95.76(88.04～98.51)
表3 TSPOT.TB、AFB、Genechip联合诊断60岁以下之间的结果(n＝115)
指标单和/或叠加 敏感性(%)(95%CI) 特异性(%)(95%CI) 阳性预测值(%)(95%CI) 阴性预测值(%)(95%CI)
TSPOT.TB 44.65(31.14～60.82) 85.50 (75.71～92.53) 63.61(48.73～76.35) 72.30(66.54～77.41)
AFB 10.86(3.38～23.56) 100.00(95.41～100.00) 100.00(47.89～100.00) 65.53(58.02～75.01)
Genechip 73.91(57.56～84.54) 98.55(93.21～99.63) 94.46(81.02～98.58) 85.71(79.06～90.52)
TSPOT.TB＋AFB 50.00(34.91～65.03) 85.51(74.93～92.81) 69.62(54.76～81.34) 71.92(65.43～77.66)
AFB＋Genechip 84.78(71.14～93.66) 98.55(92.14～99.92) 97.56(84.73～99.61) 90.62(83.05～95.07)
TSPOT.TB＋Genechip 95.65(85.24～99.46) 84.05(73.21～91.73) 80.01(69.83～87.35) 96.67(88.12～99.18)
TSPOT.TB＋AFB＋Genechip 100.00(92.26～100.00) 84.05(73.24～91.70) 80.76(70.85～87.77) 100.00(93.84～100.00)
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