Related Experiment Video
Updated: Dec 17, 2025
07:08
A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
Published on: April 6, 2021
5.4K
Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisation
A J Jääskeläinen1, S Kuivanen2, E Kekäläinen3
1HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Finland.
Summary
This study evaluated six commercial immunoassays for detecting SARS-CoV-2 antibodies against virus neutralization. Performance varied significantly, highlighting the need for careful selection and potential two-tier testing strategies for COVID-19 serodiagnostics.
Area of Science:
- Clinical diagnostics
- Immunology
- Virology
Background:
- Reliable, high-throughput serological assays are crucial for managing the COVID-19 pandemic.
- Evaluating novel virus tests requires comparison against a gold standard, such as virus neutralization.
- Commercial immunoassays vary in performance for detecting SARS-CoV-2 antibodies.
Purpose of the Study:
- To compare the performance of six commercial immunoassays for SARS-CoV-2 antibody detection.
- To assess these assays against a microneutralization test (MNT) as the gold standard.
- To provide data for optimizing SARS-CoV-2 serodiagnostic strategies.
Main Methods:
- Compared four automated and two lateral flow immunoassays against MNT.
- Utilized patient panels (N=70) with PCR-confirmed COVID-19 and negative panels (N=81).
- Determined specificity and sensitivity of each commercial assay relative to MNT results.
Main Results:
- Forty-one of 62 COVID-19 patients demonstrated neutralizing antibodies.
- Specificity ranged from 68.3% to 97.5%, and sensitivity from 43.8% to 87.8% across assays.
- Significant variability in performance was observed among the evaluated commercial SARS-CoV-2 antibody tests.
Conclusions:
- Commercial immunoassay performance for SARS-CoV-2 antibody detection is highly variable.
- Laboratories should carefully select assays and consider strategies like two-tier testing.
- Optimizing SARS-CoV-2 serodiagnostics requires rigorous evaluation against gold standards like MNT.
