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

侧向流动分析(LFA)是一种诊断测试，将液体样本应用于预先印有试剂的小硝化纤维素膜上，以检测特定的蛋白质、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：Marketand Markets 2017侧流分析市场报告)，LFA用于多种应用，包括人类诊断(例如传染病、滥用药物)、动物健康、农业、食品监测和环境检测。现有的大多数测试，如怀孕测试，都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。对许多应用来说，这个定性结果就足够了，事实上，LFA的应用主要限于定性或半定量测试。然而，当需要确定分析物的存在程度时，还有许多其他用途。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，在食品中使用真菌毒素。在接触点(POC)环境中对实验室标准定量LFA结果有很大的需求，特别是能够以非常高的灵敏度进行量化的LFA读取器系统。我们的愿景是开发和推出高度灵活、经济高效、领先的横向流动读取器平台，在POC环境中提供实验室标准测试结果。时间分辨荧光检测(TRFL)技术通过实现向更高灵敏度的LFA的范式转变，有可能在临床、动物健康、环境和农业技术检测市场等一系列领域的诊断测试领域带来革命性的变化。我们的目标是测试一种新型的横向流动测试读取器的可行性，该读取器可以在一台台式仪器上同时读取比色和荧光测试，特别是基于TRFL的测试，该仪器适用于各种环境，包括全科医生诊所、兽医诊所和农场。我们的技术将使用长寿命的基于铕的荧光团来突出分析物。利用这种标签的长衰减时间特性，我们将设计一种新颖的系统，通过时间门控技术在时间上将感兴趣的信号与背景噪声分离。据我们所知，目前还没有LFA读取器支持商业上可用的或正在开发中的同时双信号检测技术。这一创新提供了成本效益，使以前无法在紧凑的台式系统上测量的分析物能够被量化，并允许使用一个读取器来测量不同的LFA类型。“

"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."