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Related Experiment Video

Updated: Nov 4, 2025

A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
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High-throughput immunoassays for SARS-CoV-2 - considerable differences in performance when comparing three methods.

Oskar Ekelund1,2, Kim Ekblom3,4, Sofia Somajo2

  • 1Department of Clinical Microbiology, Växjö Central Hospital, Växjö, Sweden.

Infectious Diseases (London, England)
|May 31, 2021
PubMed
Summary

Performance of SARS-CoV-2 antibody tests varied significantly. The Roche assay showed the highest sensitivity, but caution is advised for using these antibody tests in low-prevalence settings.

Keywords:
COVID-19SARS-CoV-2antibodiesimmunologyserology

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Area of Science:

  • Immunology
  • Infectious Diseases
  • Diagnostic Assays

Background:

  • High-throughput assays for SARS-CoV-2 antibodies are crucial for COVID-19 pandemic management.
  • Evaluating the performance of these diagnostic tools against established criteria is essential.

Purpose of the Study:

  • To assess the performance of three high-throughput antibody assays and one rapid lateral flow test for SARS-CoV-2.
  • To compare assay performance against regulatory authority criteria.

Main Methods:

  • Analyzed 315 samples: 150 pre-pandemic, 152 SARS-CoV-2 RT-PCR positive, and 13 potentially cross-reactive.
  • Evaluated four assays: Abbott SARS-CoV-2 IgG, Roche Elecsys Anti-SARS-CoV-2, DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG, and Dynamiker 2019-nCOV IgG/IgM Rapid Test.

Main Results:

  • All assays demonstrated high specificity (96.7%–99.3%).
  • Sensitivity varied: Roche (98.7%), DiaSorin (89.0%), Abbott (80.9%), and Dynamiker (72.4%).

Conclusions:

  • Significant variability exists in the performance of evaluated SARS-CoV-2 antibody assays.
  • Assay performance differs in meeting regulatory criteria, necessitating cautious clinical implementation, especially in low-prevalence settings.