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Article

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

1
Department of Laboratory Medicine, Dankook University College of Medicine, Cheonan 31116, Korea
2
Department of Laboratory Medicine, College of Medicine, Korea University, Seoul 08308, Korea
3
Department of Microbiology, Institute for Viral Diseases, College of Medicine, Korea University, Seoul 02841, Korea
4
Creativity Lab., Creativity & Innovation Center, Samsung Electronics, Suwon 16677, Korea
*
Author to whom correspondence should be addressed.
Diagnostics 2021, 11(12), 2193; https://doi.org/10.3390/diagnostics11122193
Submission received: 27 October 2021 / Revised: 23 November 2021 / Accepted: 23 November 2021 / Published: 25 November 2021

Abstract

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, p < 0.001) compared with the test and control line ratio (T/C ratio) of the BZ-nAb (r = −0.7089, p < 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, p < 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.
Keywords: SARS-CoV-2; COVID-19; neutralizing antibodies; RDT; ELISA SARS-CoV-2; COVID-19; neutralizing antibodies; RDT; ELISA

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MDPI and ACS Style

Jung, B.K.; Yoon, J.; Bae, J.-Y.; Kim, J.; Park, M.-S.; Lee, S.Y.; Lim, C.S. Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies. Diagnostics 2021, 11, 2193. https://doi.org/10.3390/diagnostics11122193

AMA Style

Jung BK, Yoon J, Bae J-Y, Kim J, Park M-S, Lee SY, Lim CS. Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies. Diagnostics. 2021; 11(12):2193. https://doi.org/10.3390/diagnostics11122193

Chicago/Turabian Style

Jung, Bo Kyeung, Jung Yoon, Joon-Yong Bae, Jeonghun Kim, Man-Seong Park, Suk Yong Lee, and Chae Seung Lim. 2021. "Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies" Diagnostics 11, no. 12: 2193. https://doi.org/10.3390/diagnostics11122193

APA Style

Jung, B. K., Yoon, J., Bae, J.-Y., Kim, J., Park, M.-S., Lee, S. Y., & Lim, C. S. (2021). Performance Evaluation of the BZ COVID-19 Neutralizing Antibody Test for the Culture-Free and Rapid Detection of SARS-CoV-2 Neutralizing Antibodies. Diagnostics, 11(12), 2193. https://doi.org/10.3390/diagnostics11122193

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