Mycobacterium tuberculosis (Mtb) is a pathogenic bacterium that causes tuberculosis (TB). This contagious disease remains a severe health problem in the world. The disease is transmitted via inhalation of airborne droplets carrying Mtb from TB patients. Early detection of the disease is vital to prevent transmission of the infection to people in close contact with the patients. To date, there is a need of a simple, rapid, sensitive and specific diagnostic test for TB. Previous studies showed the potential of Mtb 16 kDa antigen (Ag16) in TB diagnosis. In this study, lateral flow immunoassay, also called simple strip immunoassay or immunochromatographic test (ICT) for detection of Ag16 was developed (Mtb-strip) and assessed as a potential rapid TB diagnosis method. A monoclonal antibody against Ag16 was optimized as the capturing and detection antibody on the Mtb-strip. Parameters affecting the performance of the Mtb-strip were also optimized before a complete prototype was developed. Analytical sensitivity showed that Mtb-strip was capable to detect as low as 125 ng of purified Ag16. The analytical sensitivity of Mtb-strip suggests its potential usefulness in different clinical applications.

结核分枝杆菌（Mtb）是引起结核病（TB）的致病细菌。这种传染性疾病仍然是世界范围内的严重健康问题。该病是通过吸入携带结核病患者携带Mtb的飞沫传播的。疾病的早​​期发现对于防止感染传播给与患者密切接触的人至关重要。迄今为止，需要对结核病进行简单，快速，敏感和特定的诊断测试。先前的研究表明Mtb 16 kDa抗原（Ag16）在结核病诊断中的潜力。在这项研究中，开发了用于检测Ag16的侧向流免疫测定法（也称为简单条带免疫测定法或免疫色谱测试（ICT））（Mtb条），并被评估为潜在的快速TB诊断方法。优化了针对Ag16的单克隆抗体，作为Mtb条上的捕获和检测抗体。在开发完整的原型之前，还优化了影响Mtb带性能的参数。分析灵敏度表明，Mtb条能够检测低至125 ng的纯化Ag16。Mtb带的分析灵敏度表明其在不同临床应用中的潜在用途。