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. 2022 Dec;8(12):e12614.
doi: 10.1016/j.heliyon.2022.e12614. Epub 2022 Dec 23.

Performance and correlation of ten commercial immunoassays for the detection of SARS-CoV-2 antibodies

Dewi Lokida  1 , Muhammad Karyana  2 , Herman Kosasih  3 , Yan Mardian  3 , Retna Indah Sugiyono  2 , Dona Arlinda  2 , Nurhayati Lukman  3 , Gustiani Salim  3 , Deni Pepy Butar Butar  3 , Adhella Menur Naysilla  3 , Irmansyah  2
Affiliations

Performance and correlation of ten commercial immunoassays for the detection of SARS-CoV-2 antibodies

Dewi Lokida et al. Heliyon. 2022 Dec.

Abstract

Accurate immunoassays with a good correlation to neutralizing antibodies are required to support SARS-CoV-2 diagnosis, management, vaccine deployment, and epidemiological investigation. We conducted a study to evaluate the performance and correlation of the surrogate virus neutralization test (sVNT) and other commercial immunoassays. We tested 107 sera of COVID-19 confirmed cases from three different time points, 58 confirmed non-COVID-19 sera, and 52 sera collected before the pandemic with two sVNTs, seven chemiluminescent assays, and one fluorescein assay. All assays achieved excellent sensitivity (95%-100%, ≥15 days after onset of illness), specificity (95.5%-100%), and showed moderate to high correlation with GenScript sVNT (r = 0.58 to r = 0.98), except Roche total antibodies (r = 0.48). Vazyme sVNT and Siemens total antibodies showed the highest correlation with GenScript sVNT (r = 0.98 and 0.88, respectively). Median indexes that may be used to estimate sera with the highest ability to inhibit SARS-CoV-2 and ACE-2 receptor attachment (GenScript sVNT inhibition 90%-100%) were 6.9 S/C (Abbott IgG), 161.9 COI (FREND™ IgG), 16.8 AU/ml (Snibe IgG), 40.1 S/CO (Beckman IgG), 281.9 U/ml (Mindray IgG), 712.2 U/ml (Mindray total antibodies), >10 index (Siemens total antibodies), and 95.3% inhibition (Vazyme sVNT). All ten commercial COVID-19 serology assays, with different targeting antigens, demonstrated a reliable performance, supporting the utility of those assays in clinical and research settings. However, further studies using more samples are needed to refine the results of evaluating the performances of these marketed serological assays. Reliable serological assays would be useful for clinicians, researchers and epidemiologists in confirming SARS-CoV-2 infections, observing SARS-CoV-2 transmission, and immune response post infection and vaccination, leading to better management and control of the disease.

Keywords: Antibodies; Immunoassays; SARS-CoV-2; sVNT.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Correlation between COVID-19 commercial immunoassays.
Figure 2
Figure 2
Violin Plot of nine COVID-19 commercial immunoassays for detecting SARS-CoV-2 antibodies compared to GenScript sVNT. (A). Abbott IgG compared to GenScript sVNT. (B). FREND™ IgG compared to GenScript sVNT. (C). Roche total antibodies compared to GenScript sVNT. (D). Snibe IgG compared to GenScript sVNT. (E). Beckman IgG compared to GenScript sVNT. (F). Mindray IgG compared to GenScript sVNT. (G). Mindray total antibodies compared to GenScript sVNT. (H). Siemens total antibodies compared to GenScript sVNT. (I). Vazyme sVNT compared to GenScript sVNT.
See this image and copyright information in PMC

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