Pilot study for low-cost, rapid, and accessible infectious disease diagnostics via alpha particle detection

通过阿尔法粒子检测进行低成本、快速且易于获得的传染病诊断的试点研究

基本信息

项目摘要

The following contains proprietary/privileged information that Travis Schlappi and Kevin Hickerson request not be released to persons outside the government, except for purposes of review and evaluation. Summary: Diagnosis of infectious disease is less effective when the diagnostic test does not meet one or more of the necessary standards of affordability, accessibility, and accuracy. The shortcomings of current diagnostic methods have been apparent in the COVID-19 pandemic, where some tests are accurate, but not affordable or accessible (e.g. RT-PCR tests that detect COVID RNA in a centralized lab), while other tests have become more accessible and affordable, but have low accuracy (e.g. rapid antigen tests). The high false negative rate of rapid antigen tests precludes their ability to limit disease transmission as asymptomatic carriers that test negative continue infecting others; therefore, RT-PCR or other nucleic acid (NA) tests remain the preferred testing method. This tradeoff of high accuracy with high cost, high complexity, and slow turnaround time, or low accuracy with low cost, low complexity, and fast turnaround time is an unsolved problem in medical diagnostics. The critical barrier to making progress is that the bacteria, viruses, NAs, or proteins of interest exist in the respiratory, blood, stool, or urine sample in too low of a concentration to be directly detected. To achieve sufficient sensitivity, current methods therefore amplify the pathogenic organism or amplify a target biomolecule coming from the pathogen. Even with recent advances, these amplification methods still require many steps and costly instruments to purify the target molecule from the sample and perform amplification. The goal of the proposed project is to do a pilot study for developing a new diagnostic technology that does not require target amplification, but instead detects radiologically labeled biomolecules with high sensitivity, low cost, and widespread accessibility. The proposed principle is similar to a sandwich immunoassay commonly found on lateral flow strips, such as at-home pregnancy tests. In Aim 1, nanoparticles of naturally abundant elements that have functionally identical radioisotopes will be formulated and characterized. The results from these experiments will inform which radioisotope is well-suited to be used in an integrated device. In Aim 2, a prototype will be developed for a radioactive particle detector from inexpensive, commercially available electronics, such as a CMOS sensor from a smartphone. The final detection device will be significantly simpler and cheaper than currently available tests because the multiple fluid handling and temperature control steps typically required for target purification and/or enzymatic amplification are avoided. If this pilot study proves successful, future work will develop an in vitro diagnostic device to detect infectious disease that satisfies all ASSURED criteria (affordable, sensitive, specific, user-friendly, rapid, equipment-free, deliverable). Clinical practice, disease management, pandemic preparedness, and healthcare of citizens around the globe would be transformed with rapid (<5 min), affordable (<$5), sensitive, and accessible tests for infectious diseases.
以下包含Travis Schlappi和Kevin Hickerson要求禁止的专有/特权信息 向政府以外的人发布,但为了审查和评估的目的除外。 总结: 当诊断测试不符合以下一个或多个条件时,传染病的诊断不太有效: 可负担性、可获得性和准确性的必要标准。目前诊断的缺点 方法在COVID-19大流行中很明显,其中一些测试是准确的,但负担不起, (例如,在集中实验室检测COVID RNA的RT-PCR测试),而其他测试已经变得更加容易 容易获得和负担得起,但准确性低(如快速抗原检测)。快速诊断的高假阴性率 抗原检测排除了他们作为检测阴性的无症状携带者限制疾病传播的能力 继续感染其他人;因此,RT-PCR或其他核酸(NA)测试仍然是首选的测试 法这种高精度与高成本、高复杂性和慢周转时间或低精度的折衷 具有低成本、低复杂性和快速周转时间是医学诊断中未解决的问题。临界 取得进展的障碍是细菌、病毒、NA或感兴趣的蛋白质存在于呼吸道,血液, 粪便或尿液样品中浓度太低而不能直接检测。为了获得足够的灵敏度, 因此,目前的方法扩增病原生物体或扩增来自病原生物体的靶生物分子。 病原体即使有了最新的进展,这些扩增方法仍然需要许多步骤并且成本高昂。 使用仪器从样品中纯化靶分子并进行扩增。建议的目标 项目是进行一项试点研究,以开发一种新的诊断技术,不需要靶扩增, 而是以高灵敏度、低成本和广泛应用的方式检测放射性标记的生物分子 可访问性。所提出的原理类似于通常在侧向流动条上发现的夹心免疫测定, 比如在家里做怀孕测试。在目标1中,天然丰富元素的纳米颗粒具有功能性 将配制和表征相同的放射性同位素。这些实验的结果将告诉我们, 放射性同位素非常适合用于集成装置中。在目标2中,将开发一个原型, 放射性粒子检测器,其来自廉价的市售电子器件,诸如来自 智能手机最终的检测设备将比目前可用的测试明显更简单和更便宜 因为靶纯化和/或纯化通常需要多个流体处理和温度控制步骤, 避免了酶促扩增。如果这项试点研究证明是成功的,未来的工作将开发一种体外 检测传染病的诊断设备,满足所有保证标准(可负担的,敏感的,特异的, 用户友好、快速、无需设备、可交付)。临床实践、疾病管理、流行病 地球仪将通过快速(<5分钟)、负担得起的 (<5美元),敏感,方便的传染病测试。

项目成果

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Travis S. Schlappi其他文献

Improving the Speed and Performance of Point-of-Care Diagnostics with Microfluidics
利用微流控技术提高即时诊断的速度和性能
  • DOI:
  • 发表时间:
    2018
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Travis S. Schlappi
  • 通讯作者:
    Travis S. Schlappi
Localization of Short-Chain Polyphosphate Enhances its Ability to Clot Flowing Blood Plasma
短链聚磷酸盐的定位增强了其凝固流动血浆的能力
  • DOI:
  • 发表时间:
    2017
  • 期刊:
  • 影响因子:
    4.6
  • 作者:
    J. Yeon;Nima Mazinani;Travis S. Schlappi;Karen Y. T. Chan;J. Baylis;Stephanie A. Smith;Alexander J. Donovan;Damien Kudela;G. Stucky;Y. Liu;J. Morrissey;C. Kastrup
  • 通讯作者:
    C. Kastrup

Travis S. Schlappi的其他文献

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{{ truncateString('Travis S. Schlappi', 18)}}的其他基金

Pilot study for low-cost, rapid, and accessible infectious disease diagnostics via alpha particle detection
通过阿尔法粒子检测进行低成本、快速且易于获得的传染病诊断的试点研究
  • 批准号:
    10440761
  • 财政年份:
    2022
  • 资助金额:
    $ 6.5万
  • 项目类别:
Multiplexed pathogen identification via bead-based isothermal amplification in a low-cost microfluidic device
在低成本微流体装置中通过基于珠子的等温扩增进行多重病原体识别
  • 批准号:
    10002215
  • 财政年份:
    2019
  • 资助金额:
    $ 6.5万
  • 项目类别:
Multiplexed pathogen identification via bead-based isothermal amplification in a low-cost microfluidic device
在低成本微流体装置中通过基于珠子的等温扩增进行多重病原体识别
  • 批准号:
    10264024
  • 财政年份:
    2019
  • 资助金额:
    $ 6.5万
  • 项目类别:

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