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Comparative Study
. 2021 Sep;35(9):e23921.
doi: 10.1002/jcla.23921. Epub 2021 Aug 8.

Performance evaluation of three automated quantitative immunoassays and their correlation with a surrogate virus neutralization test in coronavirus disease 19 patients and pre-pandemic controls

Kiwook Jung  1 , Sue Shin  1 , Minjeong Nam  2 , Yun Ji Hong  1 , Eun Youn Roh  1 , Kyoung Un Park  1 , Eun Young Song  1
Affiliations
Comparative Study

Performance evaluation of three automated quantitative immunoassays and their correlation with a surrogate virus neutralization test in coronavirus disease 19 patients and pre-pandemic controls

Kiwook Jung et al. J Clin Lab Anal. 2021 Sep.

Abstract

Background: SARS-CoV-2 pandemic is currently ongoing, meanwhile vaccinations are rapidly underway in some countries. The quantitative immunoassays detecting antibodies against spike antigen of SARS-CoV-2 have been developed based on the findings that they have a better correlation with the neutralizing antibody.

Methods: The performances of the Abbott Architect SARS-CoV-2 IgG II Quant, DiaSorin LIAISON SARS-CoV-2 TrimericS IgG, and Roche Elecsys anti-SARS-CoV-2 S were evaluated on 173 sera from 126 SARS-CoV-2 patients and 151 pre-pandemic sera. Their correlations with GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit were also analyzed on 173 sera from 126 SARS-CoV-2 patients.

Results: Architect SARS-CoV-2 IgG II Quant and Elecsys anti-SARS-CoV-2 S showed the highest overall sensitivity (96.0%), followed by LIAISON SARS-CoV-2 TrimericS IgG (93.6%). The specificities of Elecsys anti-SARS-CoV-2 S and LIAISON SARS-CoV-2 TrimericS IgG were 100.0%, followed by Architect SARS-CoV-2 IgG II Quant (99.3%). Regarding the correlation with cPass neutralization antibody assay, LIAISON SARS-CoV-2 TrimericS IgG showed the best correlation (Spearman rho = 0.88), followed by Architect SARS-CoV-2 IgG II Quant and Elecsys anti-SARS-CoV-2 S (all rho = 0.87).

Conclusions: The three automated quantitative immunoassays showed good diagnostic performance and strong correlations with neutralization antibodies. These assays will be useful in diagnostic assistance, evaluating the response to vaccination, and the assessment of herd immunity in the future.

Keywords: SARS-CoV-2; immunoassays; neutralizing antibody; spike antigen; virus neutralization test.

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Figures

FIGURE 1
FIGURE 1
Spearman correlation between three immunoassays and cPass neutralization antibody. (A‐C). Abbott SARS‐CoV‐2 IgG II Quant (A), Roche Elecsys anti‐SARS‐CoV‐2 S (B), and DiaSorin LIAISON SARS‐CoV‐2 TrimericS IgG (C) demonstrated strong correlations with Genscript cPass surrogate virus neutralization test (Spearman's rho of 0.87, 0.87, and 0.88 for each). (D‐F). Three immunoassays demonstrated strong correlations with each other. Spearman's rho of 0.88 between Abbott SARS‐CoV‐2 IgG II Quant and Roche Elecsys anti‐SARS‐CoV‐2 (D); Spearman's rho of 0.9 between Abbott SARS‐CoV‐2 IgG II Quant and DiaSorin LIAISON SARS‐CoV‐2 TrimericS IgG (E); Spearman's rho of 0.85 between Roche Elecsys anti‐ SARS‐CoV‐2 and DiaSorin LIAISON SARS‐CoV‐2 TrimericS IgG (F)
FIGURE 2
FIGURE 2
Receiver operating characteristics (ROC) curve analysis for three immunoassays. Area under the curve were 0.993 for Abbott Quant (A), 0.989 for DiaSorin TrimericS (B), and 0.983 for Roche S (C), which means excellent performances for all three immunoassays
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