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Establishing a high sensitivity detection method for SARS-CoV-2 IgM/IgG and developing a clinical application of this
Chunyan Zhang1, Lei Zhou2,3, Hao Liu2,3
1Chinese PLA General Hospital, Beijing, People's Republic of China.
Emerging Microbes & Infections
|August 18, 2020
Summary
A new SARS-CoV-2 antibody test strip accurately detects COVID-19 infection. This rapid, on-site testing method aids in diagnosing and predicting the clinical course of coronavirus disease 2019 (COVID-19).
Area of Science:
- Medical Diagnostics
- Immunology
- Virology
Background:
- COVID-19, caused by SARS-CoV-2, rapidly spread globally from its origin in Wuhan.
- Accurate and timely diagnostic tools are crucial for managing the pandemic.
Purpose of the Study:
- To develop and evaluate a novel SARS-CoV-2 antibody test strip.
- To assess the analytical performance and clinical utility of this diagnostic method.
Main Methods:
- Developed SARS-CoV-2 fluorescent microsphere immunochromatographic test strips.
- Combined time-resolved fluorescence immunoassay with lateral flow assay technology.
- Conducted analytical performance testing and clinical evaluation.
Main Results:
- Achieved a low limit of detection (LLOD) for SARS-CoV-2 IgG (0.121 U/L) and IgM (0.366 U/L).
- Demonstrated high specificity (94%-99.49%) and sensitivity (63.02%-90.17%) for IgM and IgG detection.
- Verified clinical significance for rapid, on-site virus testing.
Conclusions:
- The developed SARS-CoV-2 antibody test strip offers rapid, flexible, and accurate results.
- This method meets clinical requirements for on-site testing and aids in predicting COVID-19 clinical course.
