Capillary flow-driven immunoassay platform for COVID-19 antigen diagnostics

Over the last few years, the SARS-CoV-2 pandemic has made the need for rapid, affordable diagnostics more compelling than ever. While traditional laboratory diagnostics like PCR and well-plate ELISA are sensitive and specific, they can be costly and take hours to complete. Diagnostic tests that can...

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Bibliographic Details
Published in:	Analytica chimica acta Vol. 1277; p. 341634
Main Authors:	Link, Jeremy S., Carrell, Cody S., Jang, Ilhoon, Barstis, Elijah J.O., Call, Zachary D., Bellows, Rae A., O'Donnell-Sloan, John J., Terry, James S., Anderson, Loran B.R., Panraksa, Yosita, Geiss, Brian J., Dandy, David S., Henry, Charles S.
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 09-10-2023
Subjects:	Antibodies Capillary-driven microfluidics COVID-19 COVID-19 - diagnosis COVID-19 Testing Diagnostic testing Enzyme-Linked Immunosorbent Assay Humans Immunoassay Immunoassays Point-of-care SARS-CoV-2 COVID-19 Diagnostic testing SARS-CoV-2 Point-of-care Immunoassays Capillary-driven microfluidics
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Summary:	Over the last few years, the SARS-CoV-2 pandemic has made the need for rapid, affordable diagnostics more compelling than ever. While traditional laboratory diagnostics like PCR and well-plate ELISA are sensitive and specific, they can be costly and take hours to complete. Diagnostic tests that can be used at the point-of-care or at home, like lateral flow assays (LFAs) are a simple, rapid alternative, but many commercially available LFAs have been criticized for their lack of sensitivity compared to laboratory methods like well-plate ELISAs. The Capillary-Driven Immunoassay (CaDI) device described in this work uses microfluidic channels and capillary action to passively automate the steps of a traditional well-plate ELISA for visual read out. This work builds on prior capillary-flow devices by further simplifying operation and use of colorimetric detection. Upon adding sample, an enzyme-conjugated secondary antibody, wash steps, and substrate are sequentially delivered to test and control lines on a nitrocellulose strip generating a colorimetric response. The end user can visually detect SARS-CoV-2 antigen in 15–20 min by naked eye, or results can be quantified using a smartphone and software such as ImageJ. An analytical detection limit of 83 PFU/mL for SARS-CoV-2 was determined for virus in buffer, and 222 PFU/mL for virus spiked into nasal swabs using image analysis, similar to the LODs determined by traditional well-plate ELISA. Additionally, a visual detection limit of 100 PFU/mL was determined in contrived nasal swab samples by polling 20 untrained end-users. While the CaDI device was used for detecting clinically relevant levels of SARS-CoV-2 in this study, the CaDI device can be easily adapted to other immunoassay applications by changing the reagents and antibodies. [Display omitted] •Developed a device that steps of a traditional ELISA from 1 user step.•Device detects SARS-CoV-2 nucleocapsid protein at similar LOD to an ELISA.•Able to visually detect clinically relevant levels of SARS-CoV-2 in 20 min.•Aspects of the device can be adjusted to detect other diseases.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 James S. Terry: Investigation, methodology, resources, writing original draft. Zachary D. Call: Investigation. Loran B. R. Anderson: Investigation, methodology, resources, writing original draft. Ilhoon Jang: Conceptualization, methodology, investigation, writing - review and editing. Brian J. Geiss: Conceptualization, project administration, resources, writing-review and editing, funding acquisition. David S. Dandy: Conceptualization, project administration, resources, writing-review and editing. Elijah J. O. Barstis: Investigation, formal analysis, writing original draft. Yosita Panraksa: Investigation Jeremy S. Link: Conceptualization, methodology, investigation, formal analysis, writing original draft, review and editing. Cody S. Carell: Conceptualization, methodology, investigation, writing original draft. These authors contributed equally to this work John J. Odonell-Sloan: Investigation. Charles S. Henry: Conceptualization, project administration, resources, writing-review and editing, supervision, funding acquisition. Author Contributions Rae A. Bellows: Investigation.
ISSN:	0003-2670 1873-4324 1873-4324
DOI:	10.1016/j.aca.2023.341634