Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies

Rapid and accurate measurement of SARS-CoV-2 neutralizing antibodies (nAbs) can aid in understanding the development of immunity against COVID-19. This study evaluated the diagnostic performance of a rapid SARS-CoV-2 nAb detection test called the BZ COVID-19 nAb test BZ-nAb (BZ-nAb; BioZentech). Usi...

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Main Authors: Bo Kyeung Jung, Jung Yoon, Joon-Yong Bae, Jeonghun Kim, Man-Seong Park, Suk Yong Lee, Chae Seung Lim
Format: Article
Language:English
Published: MDPI AG 2021-11-01
Series:Diagnostics
Subjects:
Online Access:https://www.mdpi.com/2075-4418/11/12/2193
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author Bo Kyeung Jung
Jung Yoon
Joon-Yong Bae
Jeonghun Kim
Man-Seong Park
Suk Yong Lee
Chae Seung Lim
author_facet Bo Kyeung Jung
Jung Yoon
Joon-Yong Bae
Jeonghun Kim
Man-Seong Park
Suk Yong Lee
Chae Seung Lim
author_sort Bo Kyeung Jung
collection DOAJ
description Rapid and accurate measurement of SARS-CoV-2 neutralizing antibodies (nAbs) can aid in understanding the development of immunity against COVID-19. This study evaluated the diagnostic performance of a rapid SARS-CoV-2 nAb detection test called the BZ COVID-19 nAb test BZ-nAb (BZ-nAb; BioZentech). Using the 90% plaque-reduction neutralization test (PRNT-90) as a reference, 104 serum specimens collected from COVID-19-positive and -negative patients were grouped into 40 PRNT-90-positive and 64 PRNT-90-negative specimens. The performance of the BZ-nAb was compared with that of the cPass surrogate virus neutralization test (cPass sVNT; Genscript). The BZ-nAb showed a sensitivity ranging from 92.5%–95.0% and specificity ranging from 96.9%–100%, whereas cPass sVNT showed a sensitivity of 100% (95% confidence interval (CI) 90.5%–100%) and specificity of 98.4% (95% CI, 91.6%–100%). The dilution factor obtained with PRNT-90 showed a stronger correlation with the percent inhibition of cPass sVNT (r = 0.8660, <i>p</i> < 0.001) compared with the test and control line ratio (T/C ratio) of the BZ-nAb (r = −0.7089, <i>p</i> < 0.001). An almost perfect agreement was seen between the BZ-nAb and cPass sVNT results, with a strong negative correlation between the BZ-nAb T/C ratio and cPass sVNT percent inhibition (r = −0.8022, <i>p</i> < 0.001). In conclusion, the diagnostic performance of the BZ-nAb was comparable to that of the cPass sVNT, although the BZ-nAb had a slightly lower sensitivity.
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spelling doaj.art-b799d9ab6a60425f86ff1101c8a9f4922023-11-23T07:52:42ZengMDPI AGDiagnostics2075-44182021-11-011112219310.3390/diagnostics11122193Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing AntibodiesBo Kyeung Jung0Jung Yoon1Joon-Yong Bae2Jeonghun Kim3Man-Seong Park4Suk Yong Lee5Chae Seung Lim6Department of Laboratory Medicine, Dankook University College of Medicine, Cheonan 31116, KoreaDepartment of Laboratory Medicine, College of Medicine, Korea University, Seoul 08308, KoreaDepartment of Microbiology, Institute for Viral Diseases, College of Medicine, Korea University, Seoul 02841, KoreaDepartment of Microbiology, Institute for Viral Diseases, College of Medicine, Korea University, Seoul 02841, KoreaDepartment of Microbiology, Institute for Viral Diseases, College of Medicine, Korea University, Seoul 02841, KoreaCreativity Lab., Creativity & Innovation Center, Samsung Electronics, Suwon 16677, KoreaDepartment of Laboratory Medicine, College of Medicine, Korea University, Seoul 08308, KoreaRapid and accurate measurement of SARS-CoV-2 neutralizing antibodies (nAbs) can aid in understanding the development of immunity against COVID-19. This study evaluated the diagnostic performance of a rapid SARS-CoV-2 nAb detection test called the BZ COVID-19 nAb test BZ-nAb (BZ-nAb; BioZentech). Using the 90% plaque-reduction neutralization test (PRNT-90) as a reference, 104 serum specimens collected from COVID-19-positive and -negative patients were grouped into 40 PRNT-90-positive and 64 PRNT-90-negative specimens. The performance of the BZ-nAb was compared with that of the cPass surrogate virus neutralization test (cPass sVNT; Genscript). The BZ-nAb showed a sensitivity ranging from 92.5%–95.0% and specificity ranging from 96.9%–100%, whereas cPass sVNT showed a sensitivity of 100% (95% confidence interval (CI) 90.5%–100%) and specificity of 98.4% (95% CI, 91.6%–100%). The dilution factor obtained with PRNT-90 showed a stronger correlation with the percent inhibition of cPass sVNT (r = 0.8660, <i>p</i> < 0.001) compared with the test and control line ratio (T/C ratio) of the BZ-nAb (r = −0.7089, <i>p</i> < 0.001). An almost perfect agreement was seen between the BZ-nAb and cPass sVNT results, with a strong negative correlation between the BZ-nAb T/C ratio and cPass sVNT percent inhibition (r = −0.8022, <i>p</i> < 0.001). In conclusion, the diagnostic performance of the BZ-nAb was comparable to that of the cPass sVNT, although the BZ-nAb had a slightly lower sensitivity.https://www.mdpi.com/2075-4418/11/12/2193SARS-CoV-2COVID-19neutralizing antibodiesRDTELISA
spellingShingle Bo Kyeung Jung
Jung Yoon
Joon-Yong Bae
Jeonghun Kim
Man-Seong Park
Suk Yong Lee
Chae Seung Lim
Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies
Diagnostics
SARS-CoV-2
COVID-19
neutralizing antibodies
RDT
ELISA
title Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies
title_full Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies
title_fullStr Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies
title_full_unstemmed Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies
title_short Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies
title_sort performance evaluation of the bz covid 19 neutralizing antibody test for the culture free and rapid detection of sars cov 2 neutralizing antibodies
topic SARS-CoV-2
COVID-19
neutralizing antibodies
RDT
ELISA
url https://www.mdpi.com/2075-4418/11/12/2193
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