The performance and limitation of T-SPOT.TB for the diagnosis of TB in a high prevalence setting.

The performance and limitation of T-SPOT.TB for the diagnosis of TB in a high prevalence setting.
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T-SPOT.TB 在高患病率环境中诊断结核病的性能和局限性。

DOI:
10.3978/j.issn.2072-1439.2014.04.38
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发表时间:
2014-05
期刊:
J Thorac Dis
影响因子:
--
通讯作者:
Hu, Zhongyi
Hu, Zhongyi
中科院分区:
其他
文献类型:
--
作者:
Liu, Zhonghua;Li, Zhiqiang;Mei, Shencong;Hu, Zhongyi

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背景 结核病(TB)的诊断仍然很困难。T-SPOT.TB是一种较有前景的结核病诊断方法,但在特定人群中的诊断价值尚需进一步研究。 方法 本研究采用分层比较分析的方法,探讨T-SPOT.TB检测在中国南方结核病高发区的临床应用价值和局限性。共纳入413名受试者,包括163名肺结核(PTB)、39名肺外结核(EPTB)、106名非结核性肺部疾病(NTBPDs)、20名医务人员和85名健康对照。 结果 根据T-SPOT.TB结果,我国南方地区一般人群中潜伏性结核感染(LTBI)的发生率较高,尤其是在NTBPDS和医务人员中。T-SPOT.TB在结核感染低风险人群(如普通人群)中诊断活动性结核(ATB)具有较高的性能,但在结核感染高风险人群(如肺部疾病患者(PD)或医务人员)中,由于LTBI的干扰,T-SPOT.TB对ATB的诊断不可靠。在此条件下,测定的排除值似乎优于纳入值。我们认为T-SPOT.TB适用于EPTB和ATB合并糖尿病(DM)的筛查。然而,我们发现T-SPOT.TB在痰涂片阴性人群中的敏感性不如在痰涂片阳性人群中高。 结论 在高患病率环境中,应结合受试者的特征谨慎解释T-SPOT.TB检测结果。
BACKGROUND Tuberculosis (TB) diagnosis remains difficulty. The previous reports have shown that the T-SPOT.TB assay may be a more promising diagnostic tool for TB, however, it needs a further study to evaluate the diagnostic value of T-SPOT.TB for the specific populations in a high prevalence setting. METHODS In this present study, we conducted stratified and comparable analyses to explore the clinical value and the limitation of T-SPOT.TB assay in TB diagnosis in a high TB prevalence setting, Southern China. A total of 413 subjects including 163 pulmonary TB (PTB), 39 extrapulmonary TB (EPTB), 106 non-TB pulmonary diseases (NTBPDs), 20 medical staff and 85 healthy controls were included in the study. RESULTS According to T-SPOT.TB, there had a high incidence of latent TB infection (LTBI) in general population in Southern China, especially in the NTBPDS and medical staff. The T-SPOT.TB had a high performance in the diagnosis of active TB (ATB) in a lower risk of TB infection population such as the general population, however, the T-SPOT.TB for the diagnosis of ATB in the high risk of TB infection populations involving close contacts such as the patients with pulmonary diseases (PD) or medical staff isn't reliable due to the interference by LTBI. Under this condition, the value of rule-out of the assay was seemed to be better than that of rule-in. We believed that the T-SPOT.TB is suitable for screening both the EPTB and the ATB combined with diabetes mellitus (DM). However, we found that the sensitivity of T-SPOT.TB in sputum smear-negative population wasn't as high as that in smear-positive population. CONCLUSIONS The T-SPOT.TB testing results should be interpreted with caution combined with subject's characteristics in a high prevalence setting.
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