A rapid quantitative on-site coronavirus disease 19 serological test

Jeong Hoon Lee; Pan Kee Bae; Hyunho Kim; Yoon Ji Song; So Yeon Yi; Jungsun Kwon; Joon Seok Seo; Jeong min Lee; Han Sang Jo; Seon Mee Park; Hee Sue Park; Kyeong Seob Shin; Seok Chung; Yong Beom Shin

doi:10.1016/j.bios.2021.113406

A rapid quantitative on-site coronavirus disease 19 serological test

Jeong Hoon Lee, Pan Kee Bae, Hyunho Kim, Yoon Ji Song, So Yeon Yi, Jungsun Kwon, Joon Seok Seo, Jeong min Lee, Han Sang Jo, Seon Mee Park, Hee Sue Park, Kyeong Seob Shin, Seok Chung, Yong Beom Shin

School of Mechanical Engineering

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

On-site severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) serological assays allow for timely in-field decisions to be made regarding patient status, also enabling population-wide screening to assist in controlling the coronavirus disease 2019 (COVID-19) pandemic. Here we propose a rapid microfluidic serological assay with two unique functions of nanointerstice filling and digitized flow control, which enable the fast/robust filling of the sample fluid as well as precise regulation of duration and volume of immune reaction. Developed microfluidic assay showed enhanced limit of detection, and 91.67% sensitivity and 100% specificity (n = 152) for clinical samples of SARS CoV-2 patients. The assay enables daily monitoring of IgM/IgG titers and patterns, which could be crucial parameters for convalescence from COVID-19 and provide important insight into how the immune system responds to SARS CoV-2. The developed on-site microfluidic assay presented the mean time for IgM and IgG seroconversions, indicating that these titers plateaued days after seroconversion. The mean duration from day 0 to PCR negativity was 19.4 days (median 20 d, IQR 16–21 d), with higher IgM/IgG titres being observed when PCR positive turns into negative. Simple monitoring of these titres promotes rapid on-site detection and comprehensive understanding of the immune response of COVID-19 patients.

Original language	English
Article number	113406
Journal	Biosensors and Bioelectronics
Volume	191
DOIs	https://doi.org/10.1016/j.bios.2021.113406
Publication status	Published - 2021 Nov 1

Keywords

COVID-19
Immunoassay
Microfluidics
POCT
SARS-CoV-2

ASJC Scopus subject areas

Biotechnology
Biophysics
Biomedical Engineering
Electrochemistry

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10.1016/j.bios.2021.113406

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title = "A rapid quantitative on-site coronavirus disease 19 serological test",

abstract = "On-site severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) serological assays allow for timely in-field decisions to be made regarding patient status, also enabling population-wide screening to assist in controlling the coronavirus disease 2019 (COVID-19) pandemic. Here we propose a rapid microfluidic serological assay with two unique functions of nanointerstice filling and digitized flow control, which enable the fast/robust filling of the sample fluid as well as precise regulation of duration and volume of immune reaction. Developed microfluidic assay showed enhanced limit of detection, and 91.67% sensitivity and 100% specificity (n = 152) for clinical samples of SARS CoV-2 patients. The assay enables daily monitoring of IgM/IgG titers and patterns, which could be crucial parameters for convalescence from COVID-19 and provide important insight into how the immune system responds to SARS CoV-2. The developed on-site microfluidic assay presented the mean time for IgM and IgG seroconversions, indicating that these titers plateaued days after seroconversion. The mean duration from day 0 to PCR negativity was 19.4 days (median 20 d, IQR 16–21 d), with higher IgM/IgG titres being observed when PCR positive turns into negative. Simple monitoring of these titres promotes rapid on-site detection and comprehensive understanding of the immune response of COVID-19 patients.",

keywords = "COVID-19, Immunoassay, Microfluidics, POCT, SARS-CoV-2",

author = "Lee, {Jeong Hoon} and Bae, {Pan Kee} and Hyunho Kim and Song, {Yoon Ji} and Yi, {So Yeon} and Jungsun Kwon and Seo, {Joon Seok} and Lee, {Jeong min} and Jo, {Han Sang} and Park, {Seon Mee} and Park, {Hee Sue} and Shin, {Kyeong Seob} and Seok Chung and Shin, {Yong Beom}",

note = "Funding Information: H.K, Y.S, and S.C were supported by Samsung Research Funding and the Incubation Center of Samsung Electronics under Project SRFC-MA1502-51; P.K.B, S.Y.Y, J.K, and Y.B.S were supported by the BioNano Health-Guard Research Center funded by the Ministry of Science and ICT (MSIT) of South Korea as a Global Frontier Project (Grant number H-GUARD_2013M3A6B2078950 ). Publisher Copyright: {\textcopyright} 2021 Elsevier B.V.",

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AU - Lee, Jeong Hoon

AU - Bae, Pan Kee

AU - Kim, Hyunho

AU - Song, Yoon Ji

AU - Yi, So Yeon

AU - Kwon, Jungsun

AU - Seo, Joon Seok

AU - Lee, Jeong min

AU - Jo, Han Sang

AU - Park, Seon Mee

AU - Park, Hee Sue

AU - Shin, Kyeong Seob

AU - Chung, Seok

AU - Shin, Yong Beom

N1 - Funding Information: H.K, Y.S, and S.C were supported by Samsung Research Funding and the Incubation Center of Samsung Electronics under Project SRFC-MA1502-51; P.K.B, S.Y.Y, J.K, and Y.B.S were supported by the BioNano Health-Guard Research Center funded by the Ministry of Science and ICT (MSIT) of South Korea as a Global Frontier Project (Grant number H-GUARD_2013M3A6B2078950 ). Publisher Copyright: © 2021 Elsevier B.V.

PY - 2021/11/1

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N2 - On-site severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) serological assays allow for timely in-field decisions to be made regarding patient status, also enabling population-wide screening to assist in controlling the coronavirus disease 2019 (COVID-19) pandemic. Here we propose a rapid microfluidic serological assay with two unique functions of nanointerstice filling and digitized flow control, which enable the fast/robust filling of the sample fluid as well as precise regulation of duration and volume of immune reaction. Developed microfluidic assay showed enhanced limit of detection, and 91.67% sensitivity and 100% specificity (n = 152) for clinical samples of SARS CoV-2 patients. The assay enables daily monitoring of IgM/IgG titers and patterns, which could be crucial parameters for convalescence from COVID-19 and provide important insight into how the immune system responds to SARS CoV-2. The developed on-site microfluidic assay presented the mean time for IgM and IgG seroconversions, indicating that these titers plateaued days after seroconversion. The mean duration from day 0 to PCR negativity was 19.4 days (median 20 d, IQR 16–21 d), with higher IgM/IgG titres being observed when PCR positive turns into negative. Simple monitoring of these titres promotes rapid on-site detection and comprehensive understanding of the immune response of COVID-19 patients.

AB - On-site severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) serological assays allow for timely in-field decisions to be made regarding patient status, also enabling population-wide screening to assist in controlling the coronavirus disease 2019 (COVID-19) pandemic. Here we propose a rapid microfluidic serological assay with two unique functions of nanointerstice filling and digitized flow control, which enable the fast/robust filling of the sample fluid as well as precise regulation of duration and volume of immune reaction. Developed microfluidic assay showed enhanced limit of detection, and 91.67% sensitivity and 100% specificity (n = 152) for clinical samples of SARS CoV-2 patients. The assay enables daily monitoring of IgM/IgG titers and patterns, which could be crucial parameters for convalescence from COVID-19 and provide important insight into how the immune system responds to SARS CoV-2. The developed on-site microfluidic assay presented the mean time for IgM and IgG seroconversions, indicating that these titers plateaued days after seroconversion. The mean duration from day 0 to PCR negativity was 19.4 days (median 20 d, IQR 16–21 d), with higher IgM/IgG titres being observed when PCR positive turns into negative. Simple monitoring of these titres promotes rapid on-site detection and comprehensive understanding of the immune response of COVID-19 patients.

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A rapid quantitative on-site coronavirus disease 19 serological test

Abstract

Keywords

ASJC Scopus subject areas

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