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. 2023 Feb 9;13(4):643.
doi: 10.3390/diagnostics13040643.

Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies

Ha Nui Kim  1 , Jung Yoon  1 , Woong Sik Jang  1 , Chae Seung Lim  1
Affiliations

Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies

Ha Nui Kim et al. Diagnostics (Basel). .

Abstract

The accurate detection of anti-neutralizing SARS-CoV-2 antibodies can aid in the understanding of the development of protective immunity against COVID-19. This study evaluated the diagnostic performance of the RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test. Using the 90% plaque reduction neutralization test (PRNT90) as a reference, 200 serum samples collected from 78 COVID-19-positive and 122 COVID-19-negative patients were divided into 76 PRNT90-positive and 124 PRNT90-negative groups. The ability of the RapiSure test to detect antibodies was compared to that of the STANDARD Q COVID-19 IgM/IgG Plus test and that of PRNT90. The positive, negative, and overall percent agreement between the RapiSure and STANDARD Q test was 95.7%, 89.3%, and 91.5%, respectively, with a Cohen's kappa of 0.82. The RapiSure neutralizing antibody test results revealed a sensitivity of 93.4% and a specificity of 100% compared to the PRNT results, with an overall percent agreement of 97.5% and Cohen's kappa of 0.95. The diagnostic performance of the RapiSure test was in good agreement with the STANDARD Q COVID-19 IgM/IgG Plus test and comparable to that of the PRNT. The RapiSure S1 RBD IgG/Neutralizing Ab Test was found to be convenient and reliable and, thus, can provide valuable information for rapid clinical decisions during the COVID-19 pandemic.

Keywords: COVID-19 antibodies; SARS-CoV-2; neutralizing antibodies; rapid chromatographic immunoassay.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Schematic diagram and images of the RapiSure COVID-19 S1 RBD IgG/Neutralizing Ab Test. (a) S1 RBD IgG; (b) neutralizing antibody; and (c) images of the RapiSure COVID-19 S1 RBD IgG/Neutralizing Ab Test using representative serum samples with positive, weakly positive, and negative results from left to right.
Figure 1
Figure 1
Schematic diagram and images of the RapiSure COVID-19 S1 RBD IgG/Neutralizing Ab Test. (a) S1 RBD IgG; (b) neutralizing antibody; and (c) images of the RapiSure COVID-19 S1 RBD IgG/Neutralizing Ab Test using representative serum samples with positive, weakly positive, and negative results from left to right.
Figure 2
Figure 2
Sensitivity (%) of the RapiSure COVID-19 S1 RBD IgG/Neutralizing Ab Test in three groups: <7 days, 8–14 days, and >15 days after onset of illness. Blue bars represent the results for S1 RBD IgG; gray bars represent the results for nAbs, of which each upper light-colored bar represents a false negative result.
See this image and copyright information in PMC

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