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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
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Evaluating a novel, highly sensitive, and quantitative reagent for detecting SARS-CoV-2 antigen
Ryo Kobayashi1, Ryosei Murai2, Koichi Asanuma2
1Division of Laboratory Medicine, Sapporo Medical University Hospital, Sapporo, Japan; Department of Infection Control and Laboratory Medicine, Sapporo Medical University School of Medicine, Sapporo, Japan.
Summary
A new SARS-CoV-2 antigen test offers accurate and rapid detection of the virus. This assay is valuable for clinical diagnosis and screening, providing a simpler alternative to PCR.
Area of Science:
- Virology
- Immunology
- Medical Diagnostics
Background:
- The global spread of SARS-CoV-2 necessitates rapid and accurate diagnostic tools.
- Early detection of SARS-CoV-2 infection is crucial for disease control.
- A novel quantitative reagent for SARS-CoV-2 antigen detection has been developed.
Purpose of the Study:
- To evaluate a new quantitative reagent for SARS-CoV-2 antigen detection.
- To assess the performance of the novel antigen test using an automated laboratory device.
- To compare antigen detection with nucleic acid testing for SARS-CoV-2.
Main Methods:
- Nasopharyngeal samples were collected from 47 SARS-CoV-2-infected patients and 200 healthy donors.
- SARS-CoV-2 antigen levels were measured using Lumipulse Presto SARS-CoV-2 Ag.
- SARS-CoV-2 nucleic acid was detected using the 2019 Novel Coronavirus Detection Kit.
Main Results:
- The SARS-CoV-2 antigen test demonstrated a sensitivity of 75.7% and specificity of 96.0%.
- Concordance between antigen and nucleic acid tests was 66% in the positive group.
- A significant correlation (r=0.74) was observed between SARS-CoV-2 antigen concentration and RNA levels, with discrepancies noted later in infection or in immune patients.
Conclusions:
- The novel SARS-CoV-2 antigen detection assay is sensitive, rapid, and accurate.
- This assay offers a user-friendly diagnostic method, potentially simplifying clinical diagnosis and screening.
- The test serves as a valuable alternative to PCR-based methods, requiring no specialized techniques.
