两项用于诊断结核分枝杆菌感染的商业血液检测在常规临床实践中的应用：一项前瞻性研究。

Use in routine clinical practice of two commercial blood tests for diagnosis of infection with Mycobacterium tuberculosis: a prospective study.

作者信息

Ferrara Giovanni, Losi Monica, D'Amico Roberto, Roversi Pietro, Piro Roberto, Meacci Marisa, Meccugni Barbara, Dori Ilaria Marchetti, Andreani Alessandro, Bergamini Barbara Maria, Mussini Cristina, Rumpianesi Fabio, Fabbri Leonardo M, Richeldi Luca

机构信息

Section of Respiratory Disease, Department of Oncology, Haematology, and Respiratory Disease, University of Modena and Reggio Emilia, Via del Pozzo, 71-41100 Modena, Italy.

出版信息

Lancet. 2006 Apr 22;367(9519):1328-34. doi: 10.1016/S0140-6736(06)68579-6.

DOI:10.1016/S0140-6736(06)68579-6

PMID:16631911

Abstract

BACKGROUND

Two commercial blood assays for the diagnosis of latent tuberculosis infection--T-SPOT.TB and QuantiFERON-TB Gold--have been separately compared with the tuberculin skin test. Our aim was to compare the efficacy of all three tests in the same population sample.

METHODS

We did a prospective study in 393 consecutively enrolled patients who were tested simultaneously with T-SPOT.TB and QuantiFERON-TB Gold because of suspected latent or active tuberculosis. 318 patients also had results available for a tuberculin skin test.

FINDINGS

Overall agreement with the skin test was similar (T-SPOT.TB kappa=0.508, QuantiFERON-TB Gold kappa=0.460), but fewer BCG-vaccinated individuals were identified as positive by the two blood assays than by the tuberculin skin test (p=0.003 for T-SPOT.TB and p<0.0001 for QuantiFERON-TB Gold). Indeterminate results were significantly more frequent with QuantiFERON-TB Gold (11%, 43 of 383) than with T-SPOT.TB (3%, 12 of 383; p<0.0001) and were associated with immunosuppressive treatments for both tests. Age younger than 5 years was significantly associated with indeterminate results with QuantiFERON-TB Gold (p=0.003), but not with T-SPOT.TB. Overall, T-SPOT.TB produced significantly more positive results (38%, n=144, vs 26%, n=100, with QuantiFERON-TB Gold; p<0.0001), and close contacts of patients with active tuberculosis were more likely to be positive with T-SPOT.TB than with QuantiFERON-TB Gold (p=0.0010).

INTERPRETATION

T-SPOT.TB and QuantiFERON-TB Gold have higher specificity than the tuberculin skin test. Rates of indeterminate and positive results, however, differ between the blood tests, suggesting that they might provide different results in routine clinical practice.

摘要

背景

两种用于诊断潜伏性结核感染的商业血液检测方法——T-SPOT.TB和QuantiFERON-TB Gold——已分别与结核菌素皮肤试验进行了比较。我们的目的是在同一人群样本中比较这三种检测方法的效果。

方法

我们对393例因疑似潜伏性或活动性结核病而同时接受T-SPOT.TB和QuantiFERON-TB Gold检测的连续入组患者进行了一项前瞻性研究。318例患者也有结核菌素皮肤试验结果。

结果

与皮肤试验的总体一致性相似（T-SPOT.TB的kappa值为0.508，QuantiFERON-TB Gold的kappa值为0.460），但两种血液检测方法将接种卡介苗的个体判定为阳性的人数少于结核菌素皮肤试验（T-SPOT.TB为p=0.003，QuantiFERON-TB Gold为p<0.0001）。QuantiFERON-TB Gold的不确定结果（11%，383例中的43例）明显多于T-SPOT.TB（3%，383例中的12例；p<0.0001），且两种检测方法的不确定结果均与免疫抑制治疗有关。5岁以下儿童的QuantiFERON-TB Gold不确定结果显著相关（p=0.003），但与T-SPOT.TB无关。总体而言，T-SPOT.TB产生的阳性结果显著更多（38%，n=144例，而QuantiFERON-TB Gold为26%，n=100例；p<0.0001），活动性结核病患者的密切接触者中，T-SPOT.TB检测为阳性的可能性高于QuantiFERON-TB Gold（p=0.0010）。