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RAPID point-of-care infection detection and antibiotic-resistance TESTing enabled with laser-patterned microfluidic devices (RAPID-TEST)

使用激光图案微流体装置实现快速护理点感染检测和抗生素耐药性测试 (RAPID-TEST)

基本信息

批准号：
EP/P025757/1
负责人：
Collin Lawrence Sones
金额：
$ 100.23万
依托单位：
University of Southampton
依托单位国家：
英国
项目类别：
Research Grant
财政年份：
2017
资助国家：
英国
起止时间：
2017 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=EP%2FP025757%2F1
关键词：
RAPID point care infection detection

项目摘要

The aim of this proposal is to use our proprietary laser printing technique to develop low-cost, paper-based diagnostic tests addressing a genuine unmet healthcare need, namely the rapid identification of bacterial infections and antibiotic susceptibility profiles to guide therapeutic decision making. Our point-of-care (POC) tests will be suitable for use in a clinic or by the patients themselves as part of a pre-consultation screening process or on-going home monitoring. We have already developed our paper testing platform and demonstrated excellent microfluidic properties, establishing the proof of principle that the devices can be impregnated with a colorimetric system capable of detecting the inflammatory marker, C-reactive protein. We are now building on this concept for developing excitingly ambitious and conceptually novel diagnostic tests for use at the POC. Our target diseases, urinary tract infections (UTIs) and the chronic airway disease in cystic fibrosis (CF) are in themselves serious and currently sub-optimally managed, but importantly, the successful technology will also be applicable to a large number of other medical and industrial applications. Bacterial infections affect large numbers of people, with significant quality of life and healthcare cost consequences. There have been very few new antibiotic agents developed over the last 1-2 decades and there is increasing concern over the global epidemic of antimicrobial resistance (AMR). A major part of this problem relates directly to the widespread and indiscriminate use of broad-spectrum, non-targeted antibiotics. Choosing the correct antibiotic is however difficult in the absence of an accurate diagnosis. Current protocols for the identification of an infecting pathogen and follow-on testing of its susceptibility to antibiotics are time-consuming and require specialist microbiology culture-based procedures. These approaches are not only costly and inconvenient, but there is a period of diagnostic uncertainty during which treatment is chosen empirically and may be sub-optimal. Patients' health and well-being is adversely impacted and these delays contribute to the emergence of AMR.Our proposed novel microfluidics-based devices will uniquely serve a dual purpose - first, rapid, POC identification of a pathogen and second, cheap and expedited testing for its antibiotic resistance profile. We will achieve this through the use of an optimised enzyme-linked immunosorbent assay (ELISA) to produce an immediate colour change on contact with the chosen bacterial antigen. We have selected three problematic bacteria causing UTIs and serious infection in patients with CF. Once single detection systems have been optimised, the next task will be to multiplex them onto the same device. Coupled with the detection system will be chromogenic, agar-based culture wells containing various antibiotics. After a short period of incubation, ~ 24 hours, colour changes will indicate the antibiotics to which the bacteria are resistant. This process would significantly reduce the current diagnostic time of 3-4 days.These tools will be important and timely for GPs/Consultants in delivering an accurate antibiotic treatment of their patient's infections with significant savings in healthcare costs. For the patients, there will be reduction in symptoms and consequent improvements in quality of life. In the context of CF, a life-long disease, the devices could be used by patients in their own homes for long-term surveillance, in a fashion very aligned with the UK CF Trust's flagship SmartCare programme; this will not only empower patients in self-management, and facilitate earlier treatment, but we may ultimately be able to allow non-infected patients to have contact with each other - lack of real-time knowledge of an individual's infection status currently mandates strict segregation which has a negative impact on patients' well-being.

该提案的目的是使用我们专有的激光打印技术开发低成本的纸质诊断测试，以解决真正未满足的医疗保健需求，即快速识别细菌感染和抗生素敏感性特征，以指导治疗决策。我们的床旁（POC）测试将适合在诊所使用，或由患者自己作为咨询前筛查过程或正在进行的家庭监测的一部分。我们已经开发了我们的纸测试平台，并展示了优异的微流体特性，建立了原理证明，即设备可以浸渍有能够检测炎症标志物C反应蛋白的比色系统。我们现在正在这个概念的基础上开发令人兴奋的雄心勃勃的和概念新颖的诊断测试在POC使用。我们的目标疾病，尿路感染（UTIs）和囊性纤维化（CF）中的慢性气道疾病本身就很严重，目前管理不佳，但重要的是，成功的技术也将适用于大量其他医疗和工业应用。细菌感染影响大量人群，对生活质量和医疗保健成本产生重大影响。在过去的1- 20年中，几乎没有开发出新的抗生素制剂，并且对全球流行的抗菌素耐药性（AMR）的关注日益增加。这个问题的一个主要部分与广泛和不加区别地使用广谱、非靶向抗生素直接有关。然而，在没有准确诊断的情况下，选择正确的抗生素是困难的。目前用于鉴定感染病原体和后续测试其对抗生素的敏感性的方案是耗时的，并且需要基于微生物培养的专业程序。这些方法不仅昂贵和不方便，而且有一段诊断不确定的时期，在此期间，治疗是凭经验选择的，可能是次优的。患者的健康和福祉受到不利影响，这些延迟导致AMR的出现。我们提出的新型微流体设备将独特地服务于双重目的-第一，快速，病原体的POC鉴定，第二，廉价和快速的抗生素耐药性测试。我们将通过使用优化的酶联免疫吸附试验（ELISA）来实现这一目标，以在与所选细菌抗原接触时立即产生颜色变化。我们选择了三个问题细菌引起尿路感染和严重感染的CF患者。一旦单一检测系统得到优化，下一个任务将是将它们多路复用到同一设备上。与检测系统相结合的是含有各种抗生素的显色琼脂基培养威尔斯孔。经过一段短时间的孵育后，约24小时，颜色变化将指示细菌对哪些抗生素具有耐药性。这一过程将大大缩短目前3-4天的诊断时间。这些工具对于全科医生/顾问提供准确的抗生素治疗患者感染非常重要和及时，并显著节省医疗保健成本。对于患者来说，症状会减轻，生活质量也会随之改善。在CF这种终身疾病的背景下，患者可以在自己家中使用这些设备进行长期监测，这与英国CF信托基金会的旗舰SmartCare计划非常一致;这不但可加强病人自我管理的能力，方便病人及早接受治疗，但我们最终可能会允许未感染的病人相互接触--缺乏真实的--对个体感染状况的及时了解目前要求严格隔离，这对患者的健康有负面影响。

项目成果

期刊论文数量（10）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

A SARS-CoV-2 nucleocapsid ELISA represents a low-cost alternative to lateral flow testing for community screening in LMI countries.

DOI：
10.1016/j.jinf.2021.08.049
发表时间：
2022-01
期刊：
The Journal of infection
影响因子：
0
作者：
Humbert MV;Opurum PC;Brendish NJ;Poole S;He P;Katis I;Quaye J;Bediako Y;Duriez PJ;Eason RW;Sones C;Quaye O;Awandare GA;Christodoulides M;Clark TW;Quashie PK;McCormick CJ
通讯作者：
McCormick CJ

Laser-patterned lateral-flow devices with multiple flow-paths for semi-quantitative measurement of the inflammatory biomarker, C-reactive protein (Conference Presentation)

具有多个流路的激光图案侧流装置，用于半定量测量炎症生物标志物 C 反应蛋白（会议演示）