tetano
Editor, Senior Moderator
J Med Virol
. 2021 Feb 6.
doi: 10.1002/jmv.26854. Online ahead of print.
Evaluation of commercially available immuno-magnetic agglutination in comparison to enzyme-linked immunosorbent assays for rapid point-of-care diagnostics of COVID-19
Maria Engel Moeller[SUP] 1 [/SUP], Jeppe Fock[SUP] 2 [/SUP], Pearlyn Pah[SUP] 2 [/SUP], Antia De La Campa Veras[SUP] 2 [/SUP], Melanie Bade[SUP] 2 [/SUP], Marco Donolato[SUP] 2 [/SUP], Simone Bastrup Israelsen[SUP] 1 [/SUP], Jesper Eugen-Olsen[SUP] 3 [/SUP], Thomas Benfield[SUP] 1 4 [/SUP], Frederik Neess Engsig[SUP] 1 [/SUP]
Affiliations
Abstract
Introduction: Coronavirus Disease 2019 (COVID-19) is caused by Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Fast, accurate and simple blood-based assays for quantification of anti-SARS-CoV-2 antibodies are urgently needed to identify infected individuals and keep track of the spread of disease.
Methods: The study included 33 plasma samples from 20 individuals with confirmed COVID-19 by real time reverse transcriptase polymerase chain reaction and 40 non-COVID-19 plasma samples. Anti-SARS-CoV-2 IgM/IgA or IgG antibodies were detected by a microfluidic quantitative immunomagnetic assay (IMA) (ViroTrack Sero COVID IgM+IgA /IgG Ab, Blusense Diagnostics, Denmark) and compared to an enzyme-linked immunosorbent assay (ELISA) (EuroImmun Medizinische Labordiagnostika, Germany).
Results: Of the 33 plasma samples from the COVID-19 patients, 28 were positive for IgA/IgM or IgG by IMA and 29 samples were positive by ELISA. Sensitivity for only one sample per patient was 68% for IgA+IgM and 75% IgG by IMA and 80% by ELISA. For samples collected 14 days after symptom onset, the sensitivity of both IMA and ELISA was around 91%. Specificity of the IMA reached 100% compared to 95% for ELISA IgA and 97,5% for ELISA IgG.
Conclusion: IMA for COVID-19 is a rapid simple-to-use point-of-care (POC) test with sensitivity and specificity similar to a commercial ELISA. This article is protected by copyright. All rights reserved.
Keywords: SARS-CoV-2; blood; immuno-magnetic agglutination assay; rapid IgG-IgM-IgA combined test; surveillance.
. 2021 Feb 6.
doi: 10.1002/jmv.26854. Online ahead of print.
Evaluation of commercially available immuno-magnetic agglutination in comparison to enzyme-linked immunosorbent assays for rapid point-of-care diagnostics of COVID-19
Maria Engel Moeller[SUP] 1 [/SUP], Jeppe Fock[SUP] 2 [/SUP], Pearlyn Pah[SUP] 2 [/SUP], Antia De La Campa Veras[SUP] 2 [/SUP], Melanie Bade[SUP] 2 [/SUP], Marco Donolato[SUP] 2 [/SUP], Simone Bastrup Israelsen[SUP] 1 [/SUP], Jesper Eugen-Olsen[SUP] 3 [/SUP], Thomas Benfield[SUP] 1 4 [/SUP], Frederik Neess Engsig[SUP] 1 [/SUP]
Affiliations
- PMID: 33547818
- DOI: 10.1002/jmv.26854
Abstract
Introduction: Coronavirus Disease 2019 (COVID-19) is caused by Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Fast, accurate and simple blood-based assays for quantification of anti-SARS-CoV-2 antibodies are urgently needed to identify infected individuals and keep track of the spread of disease.
Methods: The study included 33 plasma samples from 20 individuals with confirmed COVID-19 by real time reverse transcriptase polymerase chain reaction and 40 non-COVID-19 plasma samples. Anti-SARS-CoV-2 IgM/IgA or IgG antibodies were detected by a microfluidic quantitative immunomagnetic assay (IMA) (ViroTrack Sero COVID IgM+IgA /IgG Ab, Blusense Diagnostics, Denmark) and compared to an enzyme-linked immunosorbent assay (ELISA) (EuroImmun Medizinische Labordiagnostika, Germany).
Results: Of the 33 plasma samples from the COVID-19 patients, 28 were positive for IgA/IgM or IgG by IMA and 29 samples were positive by ELISA. Sensitivity for only one sample per patient was 68% for IgA+IgM and 75% IgG by IMA and 80% by ELISA. For samples collected 14 days after symptom onset, the sensitivity of both IMA and ELISA was around 91%. Specificity of the IMA reached 100% compared to 95% for ELISA IgA and 97,5% for ELISA IgG.
Conclusion: IMA for COVID-19 is a rapid simple-to-use point-of-care (POC) test with sensitivity and specificity similar to a commercial ELISA. This article is protected by copyright. All rights reserved.
Keywords: SARS-CoV-2; blood; immuno-magnetic agglutination assay; rapid IgG-IgM-IgA combined test; surveillance.