Dual Capability Time-resolved Fluorescence and Colourimetric Based Lateral Flow Reader for High Sensitivity Diagnostics Applications

“侧流分析（LFA）是一种诊断测试，其中液体样品被施加到预先用试剂图案化的小硝酸纤维素膜上，用于检测特定的蛋白质、细胞、化学分子或微生物。现有市场每年价值约55亿美元（来源：MarketsandMarkets 2017年侧向流分析市场报告），LFA用于许多应用，包括人类诊断（例如传染病，滥用药物），动物健康，农业，食品监测和环境测试。大多数现有的测试，例如妊娠测试，是基于产生阳性或阴性测试结果的有色线的存在或不存在。对于许多应用，这种定性结果是足够的，并且事实上，LFA的应用主要限于定性或半定量测试。然而，当需要确定存在多少分析物时，存在许多其他用途。例如：在人类健康中，检测心脏标志物;在动物健康中，在动物中使用抗生素;在农业中，食品中的霉菌毒素。在接触点（POC）环境中，对实验室标准的定量LFA结果有着重要的需求，特别是LFA读取器系统，它允许以非常高的灵敏度进行定量。我们的愿景是开发和推出一个高度灵活、经济高效、领先的侧流读取器平台，在POC环境中提供实验室标准的测试结果。时间分辨荧光检测（TRFL）技术有可能通过实现向更高灵敏度的LFA的范式转变，彻底改变包括临床、动物健康、环境和农业技术检测市场在内的一系列领域的诊断检测。我们的目标是测试一种新型侧向流测试读取器的可行性，该读取器可以在单个桌面仪器中读取比色和荧光，特别是基于TRFL的测试，该桌面仪器适用于各种设置，包括GP手术，兽医诊所和农场。我们的技术将使用长寿命的铕基荧光团来突出分析物。利用这种标签的长衰减时间特性，我们将设计一种新的系统，该系统通过时间门控技术将我们感兴趣的信号与背景噪声分离。据我们所知，目前还没有支持同时双信号检测技术的LFA阅读器可用于商业或开发中。这一创新通过在紧凑的台式系统上对以前无法测量的分析物进行定量以及允许使用一个读取器来测量不同的LFA类型来提供成本效益。"

"Lateral flow assays (LFA) are diagnostics tests where a liquid sample is applied to a small nitrocellulose membrane pre-patterned with reagents for detection of particular proteins, cells, chemical molecules or microorganisms. The existing market is worth circa $5.5bn per annum (Source: MarketsandMarkets 2017 Lateral Flow Assay Market Report) with LFAs used for numerous applications including human diagnostics (e.g. infectious disease, drugs of abuse), animal health, agricultural, food monitoring and environmental testing. Most of the existing tests, such as pregnancy tests, are based on the presence or absence of coloured lines generating a positive or a negative test result.For many applications this qualitative result is sufficient and in fact the application of LFAs is largely limited to qualitative or semi-quantitative tests. However, there are many other uses when determining how much of the analyte is present is required. For example: in human health, testing of cardiac markers; in animal health, the use of antibiotics in animals; in agriculture, mycotoxins in food. There is a significant requirement for laboratory-standard quantitative LFA results in a point of contact (POC) environment and in particular a LFA reader system that allows quantification with very high sensitivity.Our vision is to develop and launch a highly flexible, cost-effective, leading-edge lateral flow reader platform that delivers laboratory standard test results in a POC environment. Time resolved fluorescence detection (TRFL) technology has the potential to revolutionise diagnostic testing across a range of areas including the clinical, animal health, environmental and agri-tech testing markets through enabling a paradigm shift to higher sensitivity LFAs. Our objective is to test the feasibility of a novel lateral flow test reader which can read both colourimetric and fluorescence, specifically TRFL, based tests in a single desktop instrument that is suitable for use in a variety of settings including GP surgeries, veterinary clinics and farms. Our technique will use long-life Europium based fluorophores to highlight the analyte. Using the long decay time property of this label, we will design a novel system which isolates our signal of interest from the background noise by separating them in time by a time-gated technique. To our knowledge there are no LFA readers supporting simultaneous dual-signal-detection technology commercially available or in development. This innovation provides cost-effectiveness by enabling quantification of analytes previously unmeasurable on a compact, desktop system as well as allowing one reader to be used to measure different LFA types."