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Performance of the FREND™ COVID-19 IgG/IgM Duo point-of-care test for SARS-CoV-2 antibody detection.
De Munck, Dorien G; Peeters, Bart; Huyghe, Evelyne; Goossens, Herman; Ieven, Margareta; Matheeussen, Veerle.
  • De Munck DG; Department of Clinical Biology, University Hospital Antwerp, Edegem, Belgium.
  • Peeters B; Department of Clinical Biology, University Hospital Antwerp, Edegem, Belgium.
  • Huyghe E; Department of Clinical Biology, University Hospital Antwerp, Edegem, Belgium.
  • Goossens H; Department of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Wilrijk, Belgium.
  • Ieven M; Department of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Wilrijk, Belgium.
  • Matheeussen V; Department of Clinical Biology, University Hospital Antwerp, Edegem, Belgium.
Acta Clin Belg ; 77(3): 647-652, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-2077515
ABSTRACT

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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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Randomized controlled trials Limits: Humans Language: English Journal: Acta Clin Belg Year: 2022 Document Type: Article Affiliation country: 17843286.2021.1940776

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Randomized controlled trials Limits: Humans Language: English Journal: Acta Clin Belg Year: 2022 Document Type: Article Affiliation country: 17843286.2021.1940776