Performance evaluation of newly developed surrogate virus neutralization tests for detecting neutralizing antibodies against SARS-CoV-2

Oh Joo Kweon; Joon Yong Bae; Yong Kwan Lim; Yoojeong Choi; Sohyun Lee; Man Seong Park; In Bum Suh; Hana Kim; Young Sam Jee; Mi Kyung Lee

doi:10.1038/s41598-023-31114-9

Performance evaluation of newly developed surrogate virus neutralization tests for detecting neutralizing antibodies against SARS-CoV-2

Oh Joo Kweon, Joon Yong Bae, Yong Kwan Lim, Yoojeong Choi, Sohyun Lee, Man Seong Park, In Bum Suh, Hana Kim, Young Sam Jee, Mi Kyung Lee

Department of Biomedical Sciences

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

2 Citations (Scopus)

Abstract

We evaluated newly developed surrogate virus neutralization tests (sVNT) for detecting neutralizing antibodies (NAbs) against the receptor binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit (MiCo BioMed, Gyeonggi-do, Republic of Korea, hereafter, “eCoV-CN”) is an enzyme-linked immunosorbent assay-based sVNT, and VERI-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (MiCo BioMed, hereafter, “rCoV-RN”) is a point-of-care lateral-flow immunochromatography test with auto-scanner. A total of 411 serum samples were evaluated. Both evaluations used a 50% plaque reduction neutralization test (PRNT₅₀) as the gold standard. Compared with PRNT₅₀, the eCoV-CN showed 98.7% positive percent agreement (PPA), 96.8% negative percent agreement (NPA), 97.4% total percent agreement (TPA), with kappa values of 0.942. The rCoV-RN showed 98.7% PPA, 97.4% NPA, 97.8% TPA, and kappa values of 0.951, comparing to PRNT₅₀. Neither assay indicated cross-reactivity for other pathogens, and the signal indexes were statistically significantly correlated to the PRNT₅₀ titer. The two evaluated sVNTs show comparable performances to the PRNT₅₀ with the advantages of technical simplicity, speed, and do not require cell culture facilities.

Original language	English
Article number	4961
Journal	Scientific reports
Volume	13
Issue number	1
DOIs	https://doi.org/10.1038/s41598-023-31114-9
Publication status	Published - 2023 Dec

Bibliographical note

Funding Information:
We thank MiCo BioMed Inc. for providing the VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and VERI-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit for this study. MiCo BioMed Inc. provided technical support and had no role in the study design, data collection, or interpretation. The human-derived materials were provided by Chung-Ang University Hospital Human Biobank.

Funding Information:
This work was supported by the National Research Foundation of Korea (NRF) Grant by the Ministry of Science and ICT (MSIT), Republic of Korea (Grant No. 2020R1A5A1018052 and NRF-2022M3A9I2017241).

Publisher Copyright:
© 2023, The Author(s).

ASJC Scopus subject areas

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@article{11da39ea04cb4e029eb93a0638247b1a,

title = "Performance evaluation of newly developed surrogate virus neutralization tests for detecting neutralizing antibodies against SARS-CoV-2",

abstract = "We evaluated newly developed surrogate virus neutralization tests (sVNT) for detecting neutralizing antibodies (NAbs) against the receptor binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit (MiCo BioMed, Gyeonggi-do, Republic of Korea, hereafter, “eCoV-CN”) is an enzyme-linked immunosorbent assay-based sVNT, and VERI-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (MiCo BioMed, hereafter, “rCoV-RN”) is a point-of-care lateral-flow immunochromatography test with auto-scanner. A total of 411 serum samples were evaluated. Both evaluations used a 50% plaque reduction neutralization test (PRNT50) as the gold standard. Compared with PRNT50, the eCoV-CN showed 98.7% positive percent agreement (PPA), 96.8% negative percent agreement (NPA), 97.4% total percent agreement (TPA), with kappa values of 0.942. The rCoV-RN showed 98.7% PPA, 97.4% NPA, 97.8% TPA, and kappa values of 0.951, comparing to PRNT50. Neither assay indicated cross-reactivity for other pathogens, and the signal indexes were statistically significantly correlated to the PRNT50 titer. The two evaluated sVNTs show comparable performances to the PRNT50 with the advantages of technical simplicity, speed, and do not require cell culture facilities.",

author = "Kweon, {Oh Joo} and Bae, {Joon Yong} and Lim, {Yong Kwan} and Yoojeong Choi and Sohyun Lee and Park, {Man Seong} and Suh, {In Bum} and Hana Kim and Jee, {Young Sam} and Lee, {Mi Kyung}",

note = "Funding Information: We thank MiCo BioMed Inc. for providing the VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and VERI-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit for this study. MiCo BioMed Inc. provided technical support and had no role in the study design, data collection, or interpretation. The human-derived materials were provided by Chung-Ang University Hospital Human Biobank. Funding Information: This work was supported by the National Research Foundation of Korea (NRF) Grant by the Ministry of Science and ICT (MSIT), Republic of Korea (Grant No. 2020R1A5A1018052 and NRF-2022M3A9I2017241). Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = dec,

doi = "10.1038/s41598-023-31114-9",

language = "English",

volume = "13",

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T1 - Performance evaluation of newly developed surrogate virus neutralization tests for detecting neutralizing antibodies against SARS-CoV-2

AU - Kweon, Oh Joo

AU - Bae, Joon Yong

AU - Lim, Yong Kwan

AU - Choi, Yoojeong

AU - Lee, Sohyun

AU - Park, Man Seong

AU - Suh, In Bum

AU - Kim, Hana

AU - Jee, Young Sam

AU - Lee, Mi Kyung

N1 - Funding Information: We thank MiCo BioMed Inc. for providing the VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and VERI-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit for this study. MiCo BioMed Inc. provided technical support and had no role in the study design, data collection, or interpretation. The human-derived materials were provided by Chung-Ang University Hospital Human Biobank. Funding Information: This work was supported by the National Research Foundation of Korea (NRF) Grant by the Ministry of Science and ICT (MSIT), Republic of Korea (Grant No. 2020R1A5A1018052 and NRF-2022M3A9I2017241). Publisher Copyright: © 2023, The Author(s).

PY - 2023/12

Y1 - 2023/12

N2 - We evaluated newly developed surrogate virus neutralization tests (sVNT) for detecting neutralizing antibodies (NAbs) against the receptor binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). VERI-Q SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit (MiCo BioMed, Gyeonggi-do, Republic of Korea, hereafter, “eCoV-CN”) is an enzyme-linked immunosorbent assay-based sVNT, and VERI-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit (MiCo BioMed, hereafter, “rCoV-RN”) is a point-of-care lateral-flow immunochromatography test with auto-scanner. A total of 411 serum samples were evaluated. Both evaluations used a 50% plaque reduction neutralization test (PRNT50) as the gold standard. Compared with PRNT50, the eCoV-CN showed 98.7% positive percent agreement (PPA), 96.8% negative percent agreement (NPA), 97.4% total percent agreement (TPA), with kappa values of 0.942. The rCoV-RN showed 98.7% PPA, 97.4% NPA, 97.8% TPA, and kappa values of 0.951, comparing to PRNT50. Neither assay indicated cross-reactivity for other pathogens, and the signal indexes were statistically significantly correlated to the PRNT50 titer. The two evaluated sVNTs show comparable performances to the PRNT50 with the advantages of technical simplicity, speed, and do not require cell culture facilities.

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Performance evaluation of newly developed surrogate virus neutralization tests for detecting neutralizing antibodies against SARS-CoV-2

Abstract

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