比较 QuantiFERON-TB Gold Plus 和 T-SPOT.TB 在发热患者中诊断活动性结核病的诊断准确性。

Comparison of diagnostic accuracy of QuantiFERON-TB Gold Plus and T-SPOT.TB in the diagnosis of active tuberculosis in febrile patients.

机构信息

Division of Infectious Diseases, Department of Internal medicine, State Key Laboratory of Complex Severe and Rare Disease, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Clinical Epidemiology Unit, Peking Union Medical College, International Clinical Epidemiology Network, Beijing, China.

出版信息

J Evid Based Med. 2022 Jun;15(2):97-105. doi: 10.1111/jebm.12477. Epub 2022 Jun 28.

DOI:10.1111/jebm.12477

PMID:35762517

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9540107/

Abstract

OBJECTIVE

This study aimed to compare the accuracy of QuantiFERON-TB Gold Plus (QFT-Plus) and T-SPOT.TB for diagnosing active tuberculosis (ATB) in febrile patients, to explore influencing factors of positive results and to verify the potential value of QFT-Plus in the identification of ATB and latent tuberculosis infection (LTBI).

METHODS

A total of 240 febrile patients with ATB (n = 80) and non-ATB (n = 160) were recruited to assess the accuracy of QFT-Plus and T-SPOT.TB for diagnosing ATB. Multivariable logistic regression was used to analyze the influencing factors of positive results.

RESULTS

The proportion of indeterminate results (ITRS) in QFT-Plus and T-SPOT.TB were 3.3% and 0%, respectively. The consistency between the results of the QFT-Plus and T-SPOT.TB was substantial. The area under the receiver operating characteristic curve (AUROC) of the QFT-Plus and T-SPOT.TB for diagnosing ATB was 0.792 and 0.849 (p = 0.070), respectively. The sensitivity of differentiating ATB from non-ATB was 92.2% in QFT-Plus versus 95.0% in T-SPOT.TB. The influencing factors of T-SPOT.TB positive result were male (odds ratio (OR) = 2.33, 95% confidence interval (CI) 1.27-4.26, p = 0.006), evidence of previous TB (OR 11.36, 95% CI 4.62-27.94, p < 0.001), while male (OR = 3.17, 95% CI 1.73-5.84, p < 0.001), evidence of previous TB (OR = 7.58, 95% CI 3.60-15.98, p <0.001), and use of immunosuppressant (OR = 0.49, 95% CI 0.260.94, p = 0.030) were influencing factors for QFT-Plus positive result. There was no significant difference in QFT-Plus in differentiating ATB from LTBI in febrile patients.

CONCLUSION

There was no significant difference between QFT-Plus and T-SPOT.TB for diagnosing ATB in febrile patients. QFT-Plus is prone to ITRS. The influencing factors including males, evidence of the previous TB, and use of immunosuppressant should be considered when interpreting positive results.

摘要

目的

本研究旨在比较结核感染 T 细胞斑点试验（T-SPOT.TB）和结核菌素纯蛋白衍生物（QuantiFERON-TB Gold Plus，QFT-Plus）检测在发热患者中诊断活动性结核病（ATB）的准确性，探讨阳性结果的影响因素，并验证 QFT-Plus 对 ATB 和潜伏性结核感染（LTBI）的潜在鉴别价值。

方法

共纳入 240 例 ATB（n = 80）和非 ATB（n = 160）发热患者，评估 QFT-Plus 和 T-SPOT.TB 检测 ATB 的准确性。采用多变量逻辑回归分析阳性结果的影响因素。

结果

QFT-Plus 和 T-SPOT.TB 检测的不确定结果（ITRS）比例分别为 3.3%和 0%。QFT-Plus 和 T-SPOT.TB 检测结果具有较高的一致性。QFT-Plus 和 T-SPOT.TB 检测对 ATB 的诊断受试者工作特征曲线（ROC）下面积（AUROC）分别为 0.792 和 0.849（p = 0.070）。QFT-Plus 对 ATB 与非 ATB 的鉴别诊断灵敏度为 92.2%，T-SPOT.TB 为 95.0%。T-SPOT.TB 阳性结果的影响因素为男性（比值比（OR）= 2.33，95%置信区间（CI）1.27-4.26，p = 0.006）、有既往 TB 证据（OR 11.36，95%CI 4.62-27.94，p < 0.001），而男性（OR = 3.17，95%CI 1.73-5.84，p < 0.001）、有既往 TB 证据（OR = 7.58，95%CI 3.60-15.98，p < 0.001）和使用免疫抑制剂（OR = 0.49，95%CI 0.26-0.94，p = 0.030）是 QFT-Plus 阳性结果的影响因素。QFT-Plus 对发热患者中 ATB 与 LTBI 的鉴别诊断无明显差异。