结核病（TB）诊断工具箱：一项印度多中心研究（2006 - 2008年）；基于PGL-Tb1和ESAT-6/CFP10抗原的血清学检测用于结核病诊断的评估
A toolbox for tuberculosis (TB) diagnosis: an Indian multi-centric study (2006-2008); evaluation of serological assays based on PGL-Tb1 and ESAT-6/CFP10 antigens for TB diagnosis.
作者信息
Lagrange Philippe H, Thangaraj Satheesh K, Dayal Rajeshwar, Deshpande Alaka, Ganguly Nirmal K, Girardi Enrico, Joshi Beenu, Katoch Kiran, Katoch Vishwa M, Kumar Manoj, Lakshmi Vemu, Leportier Marc, Longuet Christophe, Malladi Subbalaxmi V S, Mukerjee Deepali, Nair Deepthi, Raja Alamelu, Raman Balambal, Rodrigues Camilla, Sharma Pratibha, Singh Amit, Singh Sarman, Sodha Archana, Kabeer Basirudeen Syed Ahamed, Vernet Guy, Goletti Delia
机构信息
Service de Microbiologie, Hôpital Saint Louis, Paris, France.
BioMérieux, Marcy-l'Etoile, France and New Delhi, India.
出版信息
PLoS One. 2014 May 5;9(5):e96367. doi: 10.1371/journal.pone.0096367. eCollection 2014.
BACKGROUND
The aim of this multi-centric prospective study in India was to assess the accuracy of a serological test as an additional tool for diagnosing active tuberculosis (ATB). In particular, an assay based on ELISA using a phenolic glycolipid (PGL-Tb1) or a fusion protein (ESAT-6/CFP10) was compared to the tuberculin skin test (TST) and the microbiological results according to HIV status.
METHODS
Individuals with and without ATB and HIV infection were enrolled. Serology and TST results were analyzed per se and in combination with the microbiological data.
RESULTS
Among the 778 ATB patients, 102 were HIV-infected, 316 HIV-uninfected and 360 had an HIV-unknown status. Of the 945 non-ATB subjects, 559 were at low risk (community adults) and 386 at high risk of M. tuberculosis exposure. Among those with ATB, the sensitivity of ELISA-PGL-Tb1 for ATB was higher than that of ELISA-ESAT-6/CFP10, both in HIV-infected (72.3% versus 63.7%, p = 0.29) and HIV-uninfected/HIV-unknown groups (40.5% versus 28.6%; p<0.0001), whereas the specificity was around 91% for both tests. Sensitivity for ATB increased when the results of the two ELISA were combined, reaching 75.5% in the HIV-infected and 50.9% in the group of HIV-uninfected/HIV-unknown ATB, with a significant decrease of the global specificity (83.9%). Analyzing the ELISA results with the microbiological results, we observed that the sensitivity of both serology tests was independent of the ATB patients' smear microscopy (SM) status and grade. Combining the results of SM with both ELISA, the detection of ATB patients significantly increased (p<0.0001), particularly in those with extrapulmonary TB (up to 45.1%) or HIV infection (up to 83.3%). No significant association was observed between TST and serology results.
CONCLUSIONS
In this prospective multi-centric study, the combination of two rapid tests, such as SM and serology, might be useful in detecting ATB, especially in HIV-infected patients.
背景
这项在印度开展的多中心前瞻性研究旨在评估一种血清学检测作为诊断活动性结核病（ATB）辅助工具的准确性。具体而言，将基于酶联免疫吸附测定（ELISA）使用酚糖脂（PGL-Tb1）或融合蛋白（ESAT-6/CFP10）的检测方法与结核菌素皮肤试验（TST）以及根据HIV感染状况得出的微生物学检测结果进行比较。
方法
纳入患有和未患有ATB以及HIV感染的个体。对血清学和TST结果单独进行分析，并与微生物学数据相结合进行分析。
结果
在778例ATB患者中，102例为HIV感染者，316例为未感染HIV者，360例HIV感染状况未知。在945例非ATB受试者中，559例为低风险（社区成年人），386例为结核分枝杆菌暴露高风险者。在ATB患者中，ELISA-PGL-Tb1对ATB的敏感性高于ELISA-ESAT-6/CFP10，在HIV感染者中（72.3%对63.7%，p = 0.29）以及未感染HIV/ HIV感染状况未知组中（40.5%对28.6%；p<0.0001）均如此，而两种检测的特异性均约为91%。当将两种ELISA检测结果合并时，对ATB的敏感性增加，在HIV感染者中达到75.5%，在未感染HIV/ HIV感染状况未知的ATB组中达到50.9%，但总体特异性显著降低（83.9%）。将ELISA结果与微生物学结果进行分析时，我们观察到两种血清学检测的敏感性均与ATB患者的涂片显微镜检查（SM）状况和分级无关。将SM结果与两种ELISA结果相结合，ATB患者的检出率显著提高（p<0.0001），尤其是在肺外结核患者中（高达45.1%）或HIV感染者中（高达83.3%）。未观察到TST与血清学结果之间存在显著关联。
结论
在这项前瞻性多中心研究中，两种快速检测方法（如SM和血清学）的联合应用可能有助于检测ATB，尤其是在HIV感染患者中。
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