Kosin Med J.  2022 Jun;37(2):154-162. 10.7180/kmj.22.114.

Performance comparison between Elecsys Anti-SARS-CoV-2 and Anti-SARS-CoV-2 S and Atellica IM SARS-CoV-2 Total and SARS-CoV-2 IgG assays

• Jeong S
• Hong YR
• Hwang H

• KMID: 2532046
• DOI: http://doi.org/10.7180/kmj.22.114

Abstract

Background
Although serological severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests from several manufacturers have been introduced in South Korea and some are commercially available, the performance of these test kits has not yet been sufficiently validated. Therefore, we compared the performance of Elecsys Anti-SARS-CoV-2 (ACOV2) and Anti-SARS-CoV-2 S (ACOV2S) and Atellica IM SARS-CoV-2 Total (COV2T) and SARS-CoV-2 IgG (sCOVG) serological tests in this study.
Methods
A total of 186 patient samples were used. For each test, we analyzed the positive rate of serological antibody tests, precision, linearity, and agreement among the four assays.
Results
The positive rates of COV2T, sCOVG, and ACOV2S were high (81.7%–89.2%) in total, with those for ACOV2S being the highest, while those of ACOV2 were as low as 44.6%. This may be related to the high completion rate of vaccination in Korea. The repeatability and within-laboratory coefficients of variation were within the claimed allowable imprecision; however, further research is needed to establish an allowable imprecision at low concentrations. COV2T showed a linear fit, whereas sCOVG and ACOV2S were appropriately modeled with a nonlinear fit. Good agreement was found among COV2T, sCOVG, and ACOV2S; however, the agreement between ACOV2 and any one of the other methods was poor.
Conclusions
Considering the different antigens used in serological SARS-CoV-2 antibody assays, the performance of the tested assays is thought to show no significant difference for the qualitative detection of antibodies to SARS-CoV-2.

Keyword

COVID-19; Nucleocapsid proteins; Quantitative test; SARS-CoV-2; Serological antibody test; Spike protein

Figure

• 

  Fig. 1. Linearity of COV2T, sCOVG, and ACOV2S using Cobas 8000 e801 and Atellica IM automated analyzers. The COV2T (A) and sCOVG (B) were tested on an Atellica IM automated analyzer, the ACOV2S (C) being tested on a Cobas 8000 e801 automated analyzer. The COV2T showed excellent linearity within each analytical measurement range, therefore, a difference plot was not presented. SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; COV2T, Atellica IM SARS-CoV-2 Total; sCOVG, Atellica IM SARS-CoV-2 IgG; ACOV2S, Elecsys Anti-SARS-CoV-2 S.

• 

  Fig. 2. Bland-Altman plot for ACOV2S, COV2T and sCOVG. (A-C) Differences are presented as U/mL (left column) and percentage (right column) for each Bland-Altman plot. The mean presents the mean difference between x and y, and the 95% LoA lines indicate the mean difference ±1.96 standard deviation. sCOVG, Atellica IM SARS-CoV-2 IgG; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; COV2T, Atellica IM SARS-CoV-2 Total; ACOV2S, Elecsys Anti-SARS-CoV-2 S; LoA, limits of agreement.

Reference

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