Wu Xiaoxin, Wang Yeping, Weng Tianhao, Hu Chenyu, Wang Frederick X C, Wu Zhigang, Yu Dongshan, Lu Huoquan, Yao Hangping
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou Center of Clinical Experimental Medicine, The People's Hospital of Changxin, Huzhou, China Department of Bioengineering, Erik Jonsson School of Engineering and Computer Science, The University of Texas at Dallas, TX.
Medicine (Baltimore). 2017 Dec;96(51):e9350. doi: 10.1097/MD.0000000000009350.
The early secreted protein early secretory antigenic target 6(ESAT-6) and the culture filtrate protein 10 (CFP-10) are 2 antigens that are specific to Mycobacterium tuberculosis. These 2 antigens are good targets for tuberculosis (TB) detection.To rapidly diagnose TB across a variety of samples, we developed colloidal gold immunochromatographic strips (ICSs) based on ESAT-6 and CFP-10.The strips were evaluated using 233 samples, including sputum, plasma, and pleural effusion samples.The positive detection rates for ICSs for ESAT-6 and CFP-10 in sputum (culture-positive for M tuberculosis) were 100% and 91.2%, respectively. The positive detection rates for ICSs for ESAT-6 and CFP-10 in plasma were 34.1% and 29.4%, respectively. The positive detection rates for ICSs for ESAT-6 and CFP-10 in pleural effusion were 64.7% and 55.9%, respectively. Experimental analysis of culture supernatant showing that the ICS developed for ESAT-6 had a sensitivity of 100% and a specificity of 91.2%. While the ICS developed for CFP-10 had a sensitivity of 91.2% and a specificity of 88.2%.The validity of the test is limited by source of sample. The technique is sensitive and specific for samples in sputum and culture media but not for plasma or pleural effusion samples. Detection of M tuberculosis using ICSs is rapid, simple, and relatively effective; thus, ICSs are a potential screening tool for TB.
早期分泌蛋白早期分泌性抗原靶点6（ESAT-6）和培养滤液蛋白10（CFP-10）是结核分枝杆菌特有的两种抗原。这两种抗原是结核病（TB）检测的良好靶点。为了快速诊断各种样本中的结核病，我们基于ESAT-6和CFP-10开发了胶体金免疫层析试纸条（ICSs）。使用包括痰液、血浆和胸腔积液样本在内的233个样本对试纸条进行了评估。痰液（结核分枝杆菌培养阳性）中ESAT-6和CFP-10的ICSs阳性检出率分别为100%和91.2%。血浆中ESAT-6和CFP-10的ICSs阳性检出率分别为34.1%和29.4%。胸腔积液中ESAT-6和CFP-10的ICSs阳性检出率分别为64.7%和55.9%。培养上清液的实验分析表明，针对ESAT-6开发的ICS灵敏度为100%，特异性为91.2%。而针对CFP-10开发的ICS灵敏度为91.2%，特异性为88.2%。检测的有效性受样本来源的限制。该技术对痰液和培养基中的样本敏感且特异，但对血浆或胸腔积液样本不敏感。使用ICSs检测结核分枝杆菌快速、简单且相对有效；因此，ICSs是一种潜在的结核病筛查工具。
