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Evaluation of a SARS-CoV-2 lateral flow assay using the plaque reduction neutralization test
Xuping Xie1, Marisa C Nielsen2, Antonio E Muruato3
1Department of Biochemistry and Molecular Biology, University of Texas Medical Branch, Galveston, TX, USA.
Diagnostic Microbiology and Infectious Disease
|November 1, 2020
Summary
The Vazyme 2019-nCoV IgG/IgM Detection Kit showed 95.9% sensitivity and 96.1% specificity for severe acute respiratory syndrome coronavirus 2. While effective for IgG detection, its IgM performance was questionable, leading to Emergency Use Authorization disapproval.
Area of Science:
- * Virology and Immunology
- * Diagnostic Test Development and Validation
Background:
- * Accurate diagnostic tools are crucial for managing coronavirus disease 2019 (COVID-19) and understanding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemiology.
- * Lateral flow assays (LFAs) offer rapid, point-of-care testing potential but require rigorous validation.
Purpose of the Study:
- * To evaluate the performance of the Vazyme 2019-nCoV IgG/IgM Detection Kit, a lateral flow assay.
- * To compare the LFA results against the plaque reduction neutralization test (PRNT) for validation.
Main Methods:
- * Evaluation of the Vazyme 2019-nCoV IgG/IgM Detection Kit using 100 patient plasma/serum samples.
- * Comparison of LFA performance against the gold standard plaque reduction neutralization test (PRNT).
Main Results:
- * The Vazyme LFA demonstrated 95.9% sensitivity and 96.1% specificity compared to PRNT.
- * The assay performed well for severe acute respiratory syndrome coronavirus 2 IgG detection.
- * PRNT alone was insufficient to fully assess the IgM detection performance of the LFA, with observed low IgM positivity suggesting poor performance.
Conclusions:
- * The Vazyme LFA is a potentially valuable tool for IgG detection in COVID-19 diagnostics.
- * The assay's IgM detection capabilities require further investigation beyond PRNT.
- * Observed poor IgM performance contributed to the kit's recent Emergency Use Authorization disapproval.
