21ENGBIO-THE TRANSDUCING ANALYTICAL BIOSYSTEM (TABS): A PLATFORM FOR DIAGNOSTICS (TABS-DX)

21ENGBIO-转换分析生物系统 (TABS)：诊断平台 (TABS-DX)

• 批准号: BB/W011905/1
• 负责人: Elizabeth Hall
• 金额: $ 12.83万
• 依托单位: University of Cambridge
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=BB%2FW011905%2F1
• 关键词: 21ENGBIO; TRANSDUCING; ANALYTICAL; BIOSYSTEM; TABS

The world market for biosensors was $42Bn before Covid and is expected to double in the next 6yrs, still dominated by clinical diagnostics and disease management, demanding new technologies for early detection at lower cost. Covid-19 testing made in vitro diagnostics (IVDs) a household product, but IVDs are not only expected to play their part in faster identification of causative pathogens and containment of infectious disease, but there is also a need in treatment and management in acute and chronic disease, enabling earlier diagnosis with appropriate treatment, improving patient outcomes. There is interest from neonatal and paediatric units in Cystatin C (CysC) as a marker of acute renal function, as well as a predictor of morbidity and mortality. It is a much earlier indicator than the normally used creatinine and is particularly attractive for assessing kidney function in paediatrics/neonatology and intensive care, where acute fluctuations in glomerular filtration rate GFR and lack of creatinine sensitivity to incipient renal impairment puts children at risk from antibiotic toxicity. Many bioanalytical reagents for medical diagnostics are enzymes, antibodies, peptides etc. They are derived from nature and mostly produced by fermentation techniques. However, they aren't intrinsically smart materials; ie they don't usually yield an analytical signal that can be measured without further (chemical) modification of the bioanalytical reagent or addition of chemical indicators. The additional manufacturing costs and chemical reagents adds significant cost and reduces the 'green' impact of the manufacturing by fermentation. It also means that small volume biomarker measurement targets do not become commercially viable. It needs 'blockbuster' targets like glucose monitoring for diabetics to be an attractive commercial investment.In this project we will use synthetic biology to make smart analytical reagents: the TRANSDUCING ANALYTICAL BIOSYSTEM (TABS) as a platform for diagnostics (TABS-DX). The TABS can be attached to fibres and particles, making them easier to use and to store. A CysC point of care test system will be designed and a novel vacuum printing technique will be trialed to deposit the fibres or particles to produce prototype in vitro diagnostics for CysC, which will be tested in a clinical study, with the paediatrics unit.

全球生物传感器市场在COVID之前为420亿美元，预计未来6年将翻一番，仍以临床诊断和疾病管理为主，需要新技术以更低的成本进行早期检测。COVID-19检测使体外诊断（IVD）成为一种家用产品，但IVD不仅有望在更快地识别致病病原体和遏制传染病方面发挥作用，而且还需要在急性和慢性疾病的治疗和管理中发挥作用，以便通过适当的治疗进行早期诊断，改善患者的预后。新生儿和儿科单位对胱抑素C（CysC）作为急性肾功能的标志物以及发病率和死亡率的预测因子感兴趣。这是一个比通常使用的肌酐更早的指标，对于评估儿科/泌尿科和重症监护中的肾功能特别有吸引力，其中肾小球滤过率GFR的急性波动和肌酐对早期肾损害的敏感性缺乏使儿童面临抗生素毒性的风险。许多用于医学诊断的生物分析试剂是酶、抗体、肽等。它们来自自然界，大多数通过发酵技术生产。然而，它们本质上不是智能材料;即它们通常不会产生可以在不对生物分析试剂进行进一步（化学）修饰或添加化学指示剂的情况下测量的分析信号。额外的制造成本和化学试剂增加了显著的成本并降低了通过发酵制造的“绿色”影响。这也意味着小体积生物标志物测量目标不会变得商业上可行。在这个项目中，我们将使用合成生物学来制造智能分析试剂：作为诊断平台的TRANSDUCING ANALYTICAL BIOSYSTEM（TABS）（TABS-DX）。TABS可以附着在纤维和颗粒上，使它们更容易使用和储存。将设计一种CysC护理点测试系统，并将试验一种新的真空打印技术来存款纤维或颗粒，以产生CysC的体外诊断原型，该原型将在儿科临床研究中进行测试。