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

Diagnostics

Suk Yong Lee¹  Chae Seung Lim²  Jung Yoon²  Bo Kyeung Jung³  Man-Seong Park⁴  Jeonghun Kim⁴  Joon-Yong Bae⁴ 

[1] Creativity Lab., Creativity & Innovation Center, Samsung Electronics, Suwon 16677, Korea;Department of Laboratory Medicine, College of Medicine, Korea University, Seoul 08308, Korea;Department of Laboratory Medicine, Dankook University College of Medicine, Cheonan 31116, Korea;Department of Microbiology, Institute for Viral Diseases, College of Medicine, Korea University, Seoul 02841, Korea;

关键词: SARS-CoV-2;    COVID-19;    neutralizing antibodies;    RDT;    ELISA;   

DOI  :  10.3390/diagnostics11122193

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown