Handheld Microfluidic Filtration Platform Enables Rapid, Low-Cost, and Robust Self-Testing of SARS-CoV-2 Virus.

Handheld Microfluidic Filtration Platform Enables Rapid, Low-Cost, and Robust Self-Testing of SARS-CoV-2 Virus.
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DOI:
10.1002/smll.202104009
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发表时间:
2021-12
期刊:
Small (Weinheim an der Bergstrasse, Germany)
影响因子:
--
通讯作者:
Lao T
Lao T
中科院分区:
其他
文献类型:
--
作者:
Xu J;Suo W;Goulev Y;Sun L;Kerr L;Paulsson J;Zhang Y;Lao T

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The COVID-19 pandemic has led to an unprecedented crisis of both public health and economy. The prevention of further spread relies greatly on the timely and accurate identification of infected individuals. Here, we report of a novel microfluidic test kit combining ultrahigh throughput hydrodynamic filtration and sandwich immunoassay. Specifically, nano and micro- beads coated with two different, noncompetitive antibodies, are used to capture SARS-CoV-2 nucleocapsid (N) proteins simultaneously, forming larger complexes. Microfluidic filtration discards free nanobeads through pillar gaps with a defined width but retains antigen-bridged complexes in the observation zone, where a display of red color indicates the presence of antigen in the sample. This testing platform exhibits high throughput separation (<30 seconds) and enrichment of antigen that exceeds the traditional lateral flow assays or microfluidic assays, with a low limit of detection (LoD) < 100 copies/mL. In two rounds of clinical trials conducted in December 2020 (93 individuals) and August 2021 (12 individuals), our assays demonstrate high sensitivities of 95.4% and 100%, respectively, which proves this microfluidic test kit capable of detecting SARS-CoV-2 virus variants evolved over significant periods of time. Furthermore, the mass-produced chip can be fabricated at a cost of $0.98/test and the robust design allows the chip to be reused for over 50 times. All of these features make our microfluidic test kit particularly suitable for areas with inadequate medical infrastructure and a shortage of laboratory resources. A microfluidic diagnostic platform combining sandwich immunoassay and hydrodynamic filtration is presented for detection of SARS-CoV-2 virus. The nano- and micro- beads are coated with high-affinity antibodies to capture SARS-CoV-2 nucleocapsid proteins. Microfluidic filtration discards free nanobeads through pillar gaps with 30 μm in width but retains antigen-bridged complexes in the observation zone, where a display of red color indicates the presence of antigen in the sample.
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