In this study, a novel film-based immunochromatographic microfluidic device (IMD) has been developed for malaria diagnosis. A microfluidic channel was patterned on a polyethylene terephthalate (PET) double-sided adhesive film using a plotting cutter and was assembled with a polycarbonate (PC) film. The PC film used for the probe immobilization layer was activated using oxygen plasma treatment to modify the film surface with avidin-biotin linker to immobilize a capture antibody. A fluorescent labeled Pan type mAb conjugate was prepared for signal indicator after undergoing a sandwich enzyme-linked immunosorbent assay (ELISA). Target antigens include Plasmodium falciparum (P. falciparum) lactate dehydrogenase (LDH) and Plasmodium vivax (P. vivax) LDH which were injected into the sample inlet. Target antigens combined with the conjugate and then flowed to the detection chamber where two test dots and a control dot (Ctrl) exist. In the presence of P. falciparum LDH, three detection dots including test dot 1 (T1), test dot 2 (T2) and Ctrl revealed fluorescence signals where P. falciparum mAb, Pan type pLDH mAb and goat anti-mouse IgG were immobilized, respectively. When P. vivax LDH was present, T2 and Ctrl dots showed fluorescence signals while no signal was detected with the negative control. P. falciparum LDH and P. vivax LDH were successfully detected on the IMD with a detection limit of 50 ng/mL and 100 ng/mL, respectively. The IMD provides a point-of-care diagnosis platform which is able to analyze pathogenic bacteria and viruses that can be applied in the field of clinical diagnosis and food safety testing.

中文翻译：

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基于膜的免疫层析微流控设备的开发，用于疟疾诊断。

在这项研究中，已开发出一种新型的基于膜的免疫色谱微流控装置（IMD）用于疟疾诊断。使用绘图刀在聚对苯二甲酸乙二酯（PET）双面胶膜上对微流体通道进行构图，然后将其与聚碳酸酯（PC）膜组装在一起。使用氧等离子体处理活化用于探针固定层的PC膜，以用抗生物素蛋白-生物素接头修饰膜表面以固定捕获抗体。经过夹心酶联免疫吸附测定（ELISA）后，制备了荧光标记的Pan型mAb偶联物作为信号指示剂。靶抗原包括恶性疟原虫（P. falciparum）乳酸脱氢酶（LDH）和间日疟原虫（间日疟原虫））注入样品入口的LDH。靶抗原与结合物结合，然后流入检测室，在检测室中存在两个测试点和一个对照点（Ctrl）。在恶性疟原虫LDH的存在下，三个检测点包括测试点1（T1），测试点2（T2）和Ctrl显示了荧光信号，其中固定了恶性疟原虫mAb，Pan型pLDH mAb和山羊抗小鼠IgG，分别。当存在间日疟原虫LDH时，T2和Ctrl点显示荧光信号，而阴性对照未检测到信号。恶性疟原虫LDH和间日疟原虫在IMD上成功检测到LDH，检出限分别为50 ng / mL和100 ng / mL。IMD提供了即时诊断平台，该平台能够分析可在临床诊断和食品安全测试领域中应用的病原细菌和病毒。