1 Department of Transfusion, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China ; 2 Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, China ; 3 Department of Laboratory Medicine, Changzhou Tumor Hospital Soochow University, Changzhou 213001, China ; 4 Department of Emergency Medicine, Changzhou Tumor Hospital Soochow University, Changzhou 213001, China.
J Thorac Dis. 2014 Jun;6(6):713-9. doi: 10.3978/j.issn.2072-1439.2014.04.38.
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.
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.
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.
The T-SPOT.TB testing results should be interpreted with caution combined with subject's characteristics in a high prevalence setting.
结核病（TB）的诊断仍然具有挑战性。先前的报告表明，T 细胞斑点试验（T-SPOT.TB）可能是一种更有前途的 TB 诊断工具，但需要进一步研究来评估 T-SPOT.TB 在高流行地区特定人群中的诊断价值。
本研究采用分层和可比分析方法，探讨 T-SPOT.TB 检测在我国南方高 TB 流行地区的 TB 诊断中的临床价值和局限性。共纳入 413 例受试者，包括 163 例肺结核（PTB）、39 例肺外结核（EPTB）、106 例非结核肺部疾病（NTBPDs）、20 名医务人员和 85 名健康对照者。
根据 T-SPOT.TB，我国南方一般人群中潜伏性 TB 感染（LTBI）的发生率较高，尤其是在 NTBPDs 和医务人员中。T-SPOT.TB 在低 TB 感染风险人群（如一般人群）中对活动性 TB（ATB）的诊断具有较高的性能，但在高 TB 感染风险人群（如肺病患者或医务人员等密切接触者）中，T-SPOT.TB 对 ATB 的诊断不可靠，因为 LTBI 会产生干扰。在这种情况下，该检测方法排除 ATB 的价值似乎优于其诊断 ATB 的价值。我们认为 T-SPOT.TB 适合与糖尿病（DM）结合筛查 EPTB 和 ATB。然而，我们发现 T-SPOT.TB 在痰涂片阴性人群中的敏感性不如涂片阳性人群。
在高流行地区，应结合受试者的特征，谨慎解读 T-SPOT.TB 检测结果。
