Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies
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 n...
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MDPI AG
2023-02-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/13/4/643 |
| _version_ | 1797621510137970688 |
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| author | Ha Nui Kim Jung Yoon Woong Sik Jang Chae Seung Lim |
| author_facet | Ha Nui Kim Jung Yoon Woong Sik Jang Chae Seung Lim |
| author_sort | Ha Nui Kim |
| collection | DOAJ |
| description | 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 (PRNT<sub>90</sub>) as a reference, 200 serum samples collected from 78 COVID-19-positive and 122 COVID-19-negative patients were divided into 76 PRNT<sub>90</sub>-positive and 124 PRNT<sub>90</sub>-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 PRNT<sub>90</sub>. 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. |
| first_indexed | 2024-03-11T08:56:59Z |
| format | Article |
| id | doaj.art-720284a18fde4d8897278e40b9500549 |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-11T08:56:59Z |
| publishDate | 2023-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-720284a18fde4d8897278e40b95005492023-11-16T20:00:52ZengMDPI AGDiagnostics2075-44182023-02-0113464310.3390/diagnostics13040643Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 AntibodiesHa Nui Kim0Jung Yoon1Woong Sik Jang2Chae Seung Lim3Department of Laboratory Medicine, Korea University College of Medicine, Seoul 08308, Republic of KoreaDepartment of Laboratory Medicine, Korea University College of Medicine, Seoul 08308, Republic of KoreaDepartment of Laboratory Medicine, Korea University College of Medicine, Seoul 08308, Republic of KoreaDepartment of Laboratory Medicine, Korea University College of Medicine, Seoul 08308, Republic of KoreaThe 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 (PRNT<sub>90</sub>) as a reference, 200 serum samples collected from 78 COVID-19-positive and 122 COVID-19-negative patients were divided into 76 PRNT<sub>90</sub>-positive and 124 PRNT<sub>90</sub>-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 PRNT<sub>90</sub>. 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.https://www.mdpi.com/2075-4418/13/4/643COVID-19 antibodiesneutralizing antibodiesSARS-CoV-2rapid chromatographic immunoassay |
| spellingShingle | Ha Nui Kim Jung Yoon Woong Sik Jang Chae Seung Lim Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies Diagnostics COVID-19 antibodies neutralizing antibodies SARS-CoV-2 rapid chromatographic immunoassay |
| title | Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies |
| title_full | Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies |
| title_fullStr | Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies |
| title_full_unstemmed | Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies |
| title_short | Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies |
| title_sort | performance evaluation of rapisure edgc covid 19 s1 rbd igg neutralizing ab test for the rapid detection of sars cov 2 antibodies |
| topic | COVID-19 antibodies neutralizing antibodies SARS-CoV-2 rapid chromatographic immunoassay |
| url | https://www.mdpi.com/2075-4418/13/4/643 |
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