Combining faster detection with ID: a new paradigm for mycobacterial culture

项目总结/摘要 结核病是传染病发病和死亡的主要原因之一 据估计，全球有960万例活动性结核病病例，150万人死于结核病。 每年的疾病尽管出现了新技术，但培养仍然是结核病的金标准 诊断和治疗监测。2007年，世界卫生组织（WHO） 推荐使用液体培养系统，使用分枝杆菌生长指示剂 试管（MGIT）和药敏试验（DST）在中低收入国家，以解决 由于艾滋病毒合并感染和耐药结核病的高流行率，而 自动液体培养系统可以检测分枝杆菌的存在，但它们不提供 物种级别的鉴定，需要对阳性样品进行单独的鉴定试验。 Specific Technologies拥有一种新颖的传感器技术，可轻松适应现有的 液体培养系统，不仅检测分枝杆菌的存在，而且还提供 种属和菌株鉴定。在与斯坦福大学学院的合作下， Medicine，Specific Technologies已经证明了比色传感器阵列的能力， 对血培养中18种临床相关细菌进行检测和鉴定， 准确度超过1,192次试验。CSA还允许区分不相关的 耐甲氧西林金黄色葡萄球菌，表明代谢组学指纹可以 区分同一物种的不同菌株。最近，这些成果得到了推广 为了证明CSA传感器用于表征10种分枝杆菌， 液体培养在这里，我们建议进一步开发和商业验证这种廉价， 用于分枝杆菌培养的简单和新颖的感测范例，结合改进的速度， 检测与免提物种ID。菌株水平的签名，我们已经证明 可能对获得假定的易感性特征具有深远的价值， 在结核病感染的低资源环境中追踪耐药菌株。

Project Summary/Abstract Tuberculosis (TB) is one of the leading causes of morbidity and mortality from infectious disease worldwide with an estimated 9.6 million cases of active TB and 1.5 million deaths from the disease annually. Despite emerging new technologies, culture remains the gold standard in TB diagnosis and therapeutic monitoring. In 2007, the World Health Organization (WHO) recommended the use of a liquid culturing system using the Mycobacteria Growth Indicator Tube (MGIT) and drug susceptibility test (DST) in middle and low income countries to address challenges due to the high prevalence of HIV co-infection and drug-resistant TB. While automated liquid culture systems can detect the presence of mycobacteria, they do not furnish species-level identification, requiring separate identification tests for positive samples. Specific Technologies has a novel sensor technology that can be easily adapted into an existing liquid culture system to not only detect the presence of mycobacteria, but also to provide species and strain identification. In collaboration with the Stanford University School of Medicine, Specific Technologies has demonstrated the colorimetric sensor array’s ability to detect and identify that 18 clinically-relevant bacterial species in blood culture with 95% accuracy over 1,192 trials. The CSA also allowed discrimination between unrelated strains of methicillin-resistant Staphylococcus aureus, indicating that the metabolomic fingerprint can differentiate different strains of the same species. Recently, these results have been extended to demonstrate the use of CSA sensors for the characterization of 10 mycobacterial species in liquid culture. Here, we propose to further develop and commercially validate this inexpensive, simple and novel sensing paradigm for mycobacterial culture, combining improved speed to detection with the hands free species ID. The strain-level signature we have demonstrated could have profound value for obtaining putative susceptibility profiles, and epidemiologically tracking resistant strains in the low resource environments characteristic of TB infection.