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Title
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Performance of the FREND(TM) COVID-19 IgG/IgM Duo point-of-care test for SARS-CoV-2 antibody detection
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Author
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Abstract
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| Purpose: In the context of the current COVID-19 pandemic, multiple serological assays for the detection of severe acute respiratory syndrome 2 (SARS-CoV-2) immune response are currently being developed. This study compares the FRENDTM COVID-19 IgG/IgM Duo (NanoEntec) a point of care (POCT) assay with the automated Elecsys anti-SARS-CoV-2 electrochemiluminescent assay (Roche Diagnostics). Methods: Serum samples (n = 81) from PCR-confirmed SARS-CoV-2 positive patients at different time points after the onset of symptoms were analyzed with both assays. An additional 24 serum samples with cross reactivity potential were also included. Results: The sensitivity of the COVID-19 IgG/IgM Duo assay was higher as compared to the Elecsys anti-SARS-CoV-2 assay, especially when using the combined IgM/IgG result in samples analyzed within 6 days after the onset of symptoms (46.2% vs. 15.4%). The sensitivity of both assays increased with increasing time interval after the onset of symptoms and reached 100% for the COVID-19 IgG/IgM Duo assay in samples taken 14 days or more after symptom onset. Specificity of the COVID-19 IgG/IgM Duo assay was 95.8% for IgM, 91.7% for IgG and 87.5% for the combination of both. Conclusion: This study shows that the sensitivity of both assays was highly dependent on the time interval between the onset of the COVID-19 symptoms and serum sampling. Furthermore, rapid serological testing for SARS-CoV-2 antibodies by means of the FRENDTM COVID-19 IgG/IgM Duo POCT assay showed a comparable diagnostic performance as the reference automated immunoassay. |
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Language
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English
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Source (journal)
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Acta clinica Belgica / Belgian Society of Internal Medicine [Ghent]; Royal Belgian Society of Laboratory Medicine. - Gent, 1997, currens
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Publication
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Abingdon
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Taylor & francis ltd
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2022
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ISSN
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1784-3286
[print]
2295-3337
[online]
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DOI
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10.1080/17843286.2021.1940776
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Volume/pages
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77
:3
(2022)
, p. 647-652
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ISI
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000664051300001
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Pubmed ID
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34152943
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Full text (Publisher's DOI)
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Full text (open access)
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