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

将更快的检测与 ID 相结合：分枝杆菌培养的新范例

• 批准号: 9240535
• 负责人: PAUL RHODES
• 金额: $ 100万
• 依托单位: SPECIFIC DIAGNOSTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-01 至 2020-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9240535
• 关键词: Address; Award; Blood; Cessation of life; Characteristics; Classification; Clinical; Collaborations; Communicable Diseases; Data; Detection; Development; Diagnosis; Discrimination; Disease; Drug resistance in tuberculosis; Environment; Epidemiology; Fingerprint; Genus Mycobacterium; Goals; Gold; Growth; HIV; Hand; High Prevalence; Infection; Laboratories; Libraries; Liquid substance; Measures; Monitor; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Organism; Patients; Performance; Pharmaceutical Preparations; Phase; Predisposition; Research; Resources; Sampling; Sensitivity and Specificity; Speed; Sputum; Support System; System; Technology; Testing; Therapeutic; Time; Tube; Tuberculosis; Universities; Validation; Variant; Work; World Health Organization; clinically relevant; co-infection; commercialization; improved; instrument; low and middle-income countries; medical schools; metabolomics; methicillin resistant Staphylococcus aureus; microorganism; mortality; mycobacterial; new technology; novel; resistant strain; sensor; tuberculosis drugs

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.

项目概要/摘要 结核病 (TB) 是传染病发病和死亡的主要原因之一 全球估计有 960 万活动性结核病病例，150 万人死于结核病 尽管新技术层出不穷，文化仍然是结核病的黄金标准。 2007年，世界卫生组织（WHO）提出了诊断和治疗监测。 建议使用分枝杆菌生长指示剂的液体培养系统 中低收入国家的管（MGIT）和药敏试验（DST）以解决 艾滋病毒合并感染和耐药结核病的高患病率带来的挑战。 自动化液体培养系统可以检测分枝杆菌的存在，但它们不提供 物种层面的鉴定，需要对阳性样本进行单独的鉴定测试。 Specific Technologies 拥有一种新颖的传感器技术，可以轻松适应现有的 液体培养系统不仅可以检测分枝杆菌的存在，还可以提供 与斯坦福大学学院合作进行物种和菌株鉴定。 医学、特定技术已经证明了比色传感器阵列的能力 检测并鉴定血培养物中的 18 种临床相关细菌，检测率达 95% CSA 还允许区分不相关的菌株。超过 1,192 次试验的准确性。 耐甲氧西林金黄色葡萄球菌，表明代谢组指纹可以 最近，这些结果得到了扩展。 演示使用 CSA 传感器来表征 10 种分枝杆菌物种 在这里，我们建议进一步开发和商业验证这种廉价的、 用于分枝杆菌培养的简单而新颖的传感范例，将提高的速度与 使用免提物种 ID 进行检测 我们已经展示了菌株级别的特征。 对于获得假定的易感性概况可能具有深远的价值，并且在流行病学上 在结核病感染的资源匮乏的环境中追踪耐药菌株。