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Updated: Dec 20, 2025
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
Diagnostic performance of immunochromatography assay for rapid detection of IgM and IgG in coronavirus disease 2019
Jung-Yoon Choe1, Ji-Won Kim1, Hyun Hee Kwon2
1Division of Rheumatology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Republic of Korea.
Insights
This study shows that an immunochromatography-based rapid test accurately detects COVID-19 antibodies (IgM/IgG). The test demonstrated high sensitivity and specificity, making it a practical tool for diagnosing coronavirus disease 2019.
Area of Science:
- Medical Diagnostics
- Immunology
- Infectious Diseases
Background:
- Serologic assays are crucial for detecting coronavirus disease 2019 (COVID-19) infection.
- Evaluating the diagnostic performance of rapid immunochromatography-based tests is essential for widespread application.
Purpose of the Study:
- To assess the diagnostic accuracy of an immunochromatography-based COVID-19 immunoglobulin G (IgG)/immunoglobulin M (IgM) rapid test.
- To compare the test's performance against real-time reverse transcription-polymerase chain reaction (RT-PCR) using human serum samples.
Main Methods:
- 149 subjects were enrolled, categorized by RT-PCR results (70 COVID-19 positive, 79 negative).
- An immunochromatography-based COVID-19 IgG/IgM rapid test was performed on serum samples.
- Key performance metrics including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and receiver operating characteristic (ROC) curve were calculated with 95% confidence intervals (CI).
Main Results:
- The test detected IgM or IgG antibodies in 92.9% of COVID-19 positive subjects and 3.8% of negative subjects.
- Sensitivity was 92.9% (95% CI: 84.1-97.6) and specificity was 96.2% (95% CI: 89.3-99.2).
- Positive predictive value (PPV) reached 95.6% and negative predictive value (NPV) was 93.8%, with an area under the ROC curve of 0.945 (95% CI: 0.903-0.988).
Conclusions:
- The immunochromatography-based COVID-19 IgG/IgM rapid test demonstrates high diagnostic performance.
- The assay is a useful and practical tool for detecting COVID-19, particularly when IgM or IgG antibodies are present.
Abstract:
Serologic assays have been developed to detect infection with coronavirus disease 2019 (COVID-19). This study was conducted to evaluate the diagnostic performance of an immunochromatography-based assay of human serum for COVID-19. The present study enrolled 149 subjects who had been tested by real-time reverse transcription-polymerase chain reaction (RT-PCR) for COVID-19 and were classified into two groups: 70 who were positive for COVID-19 and 79 who were negative for COVID-19 based on RT-PCR. An immunochromatography-based COVID-19 immunoglobulin G (IgG)/immunoglobulin M (IgM) rapid test on the sera of the study population was applied to measure the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and receiver operating characteristic (ROC) curve compared to RT-PCR, with a 95% confidence interval (CI). IgM or IgG antibodies were detected in 65 subjects (92.9%) classified as positive for COVID-19 and in three subjects (3.8%) classified as negative for COVID-19. The sensitivity and specificity percentages for IgM or IgG antibodies were 92.9% (95% CI: 84.1-97.6) and 96.2% (95% CI: 89.3-99.2), respectively, with 95.6% PPV and 93.8% NPV. The PPV rapidly improved with increasing disease prevalence from 19.8% to 96.1% in the presence of either IgM or IgG, while the NPV remained high with a change from 99.9% to 93.1%. The area under the ROC curve was 0.945 (95% CI: 0.903-0.988) for subjects with either IgM or IgG positivity. In conclusion, the immunochromatography-based COVID-19 IgG/IgM rapid test is a useful and practical diagnostic assay for detection of COVID-19, especially in the presence of IgM or IgG antibodies.
