Biomedical Diagnostics Institute, National Centre for Sensor Research, Dublin City University, Ireland; School of Physical Sciences, Dublin City University, Ireland.
INSIGHT: Centre for Data Analytics, National Centre for Sensor Research, Dublin City University, Ireland.
Biosens Bioelectron. 2014 Jun 15;56:352-8. doi: 10.1016/j.bios.2014.01.031. Epub 2014 Jan 27.
Mortality rates of up to 50% have been reported after liver failure due to drug-induced hepatotoxicity and certain viral infections (Gao et al., 2008). These adverse conditions frequently affect HIV and tuberculosis patients on regular medication in resource-poor settings. Here, we report full integration of sample preparation with the read-out of a 5-parameter liver assay panel (LAP) on a portable, easy-to-use, fast and cost-efficient centrifugal microfluidic analysis system (CMAS). Our unique, dissolvable-film based centrifugo-pneumatic valving was employed to provide sample-to-answer fashion automation for plasma extraction (from finger-prick of blood), metering and aliquoting into separate reaction chambers for parallelized colorimetric quantification during rotation. The entire LAP completes in less than 20 min while using only a tenth the reagent volumes when compared with standard hospital laboratory tests. Accuracy of in-situ liver function screening was validated by 96 separate tests with an average coefficient of variance (CV) of 7.9% compared to benchtop and hospital lab tests. Unpaired two sample statistical t-tests were used to compare the means of CMAS and benchtop reader, on one hand; and CMAS and hospital tests on the other. The results demonstrate no statistical difference between the respective means with 94% and 92% certainty of equivalence, respectively. The portable platform thus saves significant time, labour and costs compared to established technologies, and therefore complies with typical restrictions on lab infrastructure, maintenance, operator skill and costs prevalent in many field clinics of the developing world. It has been successfully deployed to a centralised lab in Nigeria.
据报道，药物性肝毒性和某些病毒性感染导致肝衰竭的死亡率高达 50%（Gao 等人，2008）。在资源匮乏的环境中，这些不利情况经常影响正在接受常规药物治疗的艾滋病毒和结核病患者。在这里，我们报告了在便携式、易于使用、快速且具有成本效益的离心微流控分析系统（CMAS）上，完全将样品制备与 5 个参数的肝分析试剂盒（LAP）的检测结果集成在一起。我们独特的、基于溶解膜的离心气动阀用于提供从血浆提取（指尖采血）、计量和分配到单独的反应室的样本到答案的自动化，用于旋转时的平行比色定量。整个 LAP 不到 20 分钟即可完成，与标准医院实验室测试相比，仅使用十分之一的试剂体积。通过 96 项单独的测试验证了原位肝功能筛选的准确性，平均变异系数（CV）为 7.9%，与台式和医院实验室测试相比。使用未配对的两样本统计 t 检验比较了 CMAS 和台式读数器一方面的平均值；以及 CMAS 和医院测试的平均值。结果表明，各自平均值之间没有统计学差异，置信度分别为 94%和 92%。与现有技术相比，该便携式平台在时间、劳动力和成本方面具有显著优势，因此符合许多发展中国家现场诊所中常见的实验室基础设施、维护、操作人员技能和成本的典型限制。它已成功部署到尼日利亚的一个集中实验室。
