Journal Home > Volume 12 , Issue 4

To combat the COVID-19 pandemic, serologic lateral flow immunoassays are required to facilitate accurate diagnosis of SARS-CoV-2 infection and confirmation of molecular results. This study evaluated sensitivity of two different designs of colloidal gold serologic tests (antigen based total antibody test and antibody based IgG test) by using residual serum samples from patients who were evaluated for SARS-CoV-2 infection status by polymerase chain reaction (PCR). The results showed 100% specificity for both tests, while when testing of 16 positive patients, the data showed 90% sensitivity for total antibody test and 30% for IgG test. This study demonstrates high diagnostic accuracy for anti-SARS-CoV-2 total antibody tests and will facilitate further development and selection of serological assays.


menu
Abstract
Full text
Outline
About this article

Development and Head-to-Head Comparison of TwoColloidal gold Based SerologicLateral Flow Assays for SARS-CoV-2 Antibody Tests

Show Author's information Jing Tian1Kan Wang2Yanlei Liu2Hui liang1Xueling Li1Daxiang Cui1,2( )
National Engineering Research Center for Nanotechnology, Shanghai, China
Institute of Nano Biomedicine and Engineering, Shanghai Engineering Research Centre for Intelligent Diagnosis and Treatment Instrument, Department of Instrument Science and Engineering, School of Electronic Information and Electrical Engineering, Shanghai Jiao Tong University, Shanghai, China

Abstract

To combat the COVID-19 pandemic, serologic lateral flow immunoassays are required to facilitate accurate diagnosis of SARS-CoV-2 infection and confirmation of molecular results. This study evaluated sensitivity of two different designs of colloidal gold serologic tests (antigen based total antibody test and antibody based IgG test) by using residual serum samples from patients who were evaluated for SARS-CoV-2 infection status by polymerase chain reaction (PCR). The results showed 100% specificity for both tests, while when testing of 16 positive patients, the data showed 90% sensitivity for total antibody test and 30% for IgG test. This study demonstrates high diagnostic accuracy for anti-SARS-CoV-2 total antibody tests and will facilitate further development and selection of serological assays.

Keywords: COVID-19, SARS-CoV-2, Rapid point-of-care tests (POCTs), Serologic lateral flow assays (LFA), Colloidal gold

References(9)

[1]

Coronaviridae Study Group of the International Committee on Taxonomy of Viruses, The species severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol, 2020, 5(4): 536-544.

[2]

K.G. Andersen, A. Rambaut, W.I. Lipkin, et al., The proximal origin of SARS-CoV-2. Nat Med, 2020, 26: 450-452.

[3]

A. Grifoni, J. Sidney, et al., A sequence homology and bioinformatic approach can predict candidate targets for immune responses to SARS-CoV-2. Cell Host & Microbe, 2020, 27(4): 671-680.e2.

[4]

A. Wu, Y. Peng, et al., Genome composition and divergence of the novel coronavirus (2019-nCoV) originating in China. Cell Host & Microbe, 2020, 27(3): 325-328.

[5]

M. Qiu, Y. Shi, et al., Antibody responses to individual proteins of SARS coronavirus and their neutralization activities Microbes and Infection, 2005, 7: 882-889.

[6]

Q.X. Long, B.Z. Liu, et al., Antibody responses to SARS-CoV-2 in patients with COVID-19. Nature Medicine, 2020, 26: 845-848.

[7]
B. Meyer, et al., Validation of a commercially available SARS-CoV-2 serological immunoassay, Clinical Microbiology and Infection.
[8]
S. E Conklin, et al., Evaluation of Serological SARS-CoV-2 Lateral Flow Assays for Rapid Point of Care Testing. MedRxiv.
[9]

E. Brochot, B. Demey, et al., Comparison of different serological assays for SARS-CoV-2 in real life. Journal of Clinical Virology, 2020, 130: 104569.

Publication history
Copyright
Rights and permissions

Publication history

Received: 25 August 2020
Accepted: 31 August 2020
Published: 25 October 2020
Issue date: December 2020

Copyright

© Jing Tian, Wang Kan, Liu Yanlei, Liang Hui, Li Xueling, and Cui Daxiang.

Rights and permissions

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Return