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Diagnostic performance of seven rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients.
Van Elslande, J; Houben, E; Depypere, M; Brackenier, A; Desmet, S; André, E; Van Ranst, M; Lagrou, K; Vermeersch, P.
  • Van Elslande J; Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium.
  • Houben E; Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium.
  • Depypere M; Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium.
  • Brackenier A; Leadlife B.V., Gent, Belgium.
  • Desmet S; Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
  • André E; Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
  • Van Ranst M; Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Laboratory of Clinical and Epidemiological Virology (Rega Institute), KU Leuven, Leuven, Belgium.
  • Lagrou K; Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.
  • Vermeersch P; Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: pieter.vermeersch@uzleuven.be.
Clin Microbiol Infect ; 26(8): 1082-1087, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-594311
ABSTRACT

OBJECTIVES:

To evaluate the diagnostic performance of seven rapid IgG/IgM tests and the Euroimmun IgA/IgG ELISA for antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in COVID-19 patients.

METHODS:

Specificity was evaluated in 103 samples collected before January 2020. Sensitivity and time to seropositivity was evaluated in 167 samples from 94 patients with COVID-19 confirmed with RT-PCR on nasopharyngeal swab.

RESULTS:

Specificity (confidence interval) of lateral flow assays (LFAs) was ≥91.3% (84.0-95.5) for IgM, ≥90.3% (82.9-94.8) for IgG, and ≥85.4% (77.2-91.1) for the combination IgM OR IgG. Specificity of the ELISA was 96.1% (90.1-98.8) for IgG and only 73.8% (64.5-81.4) for IgA. Sensitivity 14-25 days after the onset of symptoms was between ≥92.1% (78.5-98.0) and 100% (95.7-100) for IgG LFA compared to 89.5% (75.3-96.4) for IgG ELISA. Positivity of IgM OR IgG for LFA resulted in a decrease in specificity compared to IgG alone without a gain in diagnostic performance, except for VivaDiag. The results for IgM varied significantly between the LFAs with an average overall agreement of only 70% compared to 89% for IgG. The average dynamic trend to seropositivity for IgM was not shorter than for IgG. At the time of hospital admission the sensitivity of LFA was <60%.

CONCLUSIONS:

Sensitivity for the detection of IgG antibodies 14-25 days after the onset of symptoms was ≥92.1% for all seven LFAs compared to 89.5% for the IgG ELISA. The results for IgM varied significantly, and including IgM antibodies in addition to IgG for the interpretation of LFAs did not improve the diagnostic performance.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus / Antibodies, Viral / Antigens, Viral Type of study: Diagnostic study / Experimental Studies Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Clin Microbiol Infect Journal subject: Communicable Diseases / Microbiology Year: 2020 Document Type: Article Affiliation country: J.cmi.2020.05.023

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus / Antibodies, Viral / Antigens, Viral Type of study: Diagnostic study / Experimental Studies Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Clin Microbiol Infect Journal subject: Communicable Diseases / Microbiology Year: 2020 Document Type: Article Affiliation country: J.cmi.2020.05.023