1. Evaluation of commercially available immuno-magnetic agglutination in comparison to enzyme-linked immunosorbent assays for rapid point-of-care diagnostics of COVID-19.
- Author
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Moeller ME, Fock J, Pah P, Veras AC, Bade M, Donolato M, Israelsen SB, Eugen-Olsen J, Benfield T, and Engsig FN
- Subjects
- Aged, Female, Humans, Immunoglobulin A blood, Immunoglobulin A isolation & purification, Immunoglobulin G blood, Immunoglobulin G isolation & purification, Immunoglobulin M blood, Immunoglobulin M isolation & purification, Male, Middle Aged, RNA, Viral, Reverse Transcriptase Polymerase Chain Reaction, Sensitivity and Specificity, COVID-19 diagnosis, COVID-19 Testing methods, Enzyme-Linked Immunosorbent Assay methods, Immunomagnetic Separation methods, Point-of-Care Testing, SARS-CoV-2
- 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 immunoglobulin M (IgM)/immunoglobulin A (IgA) or immunoglobulin G (IgG) antibodies were detected by a microfluidic quantitative immunomagnetic assay (IMA) (ViroTrack Sero COVID IgM + IgA/IgG Ab, Blusense Diagnostics) and compared to an enzyme-linked immunosorbent assay (ELISA) (EuroImmun Medizinische Labordiagnostika)., 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%. The 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 test with sensitivity and specificity similar to a commercial ELISA., (© 2021 Wiley Periodicals LLC.)
- Published
- 2021
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