Your browser doesn't support javascript.
Analytical and clinical performances of five immunoassays for the detection of SARS-CoV-2 antibodies in comparison with neutralization activity.
Padoan, Andrea; Bonfante, Francesco; Pagliari, Matteo; Bortolami, Alessio; Negrini, Davide; Zuin, Silvia; Bozzato, Dania; Cosma, Chiara; Sciacovelli, Laura; Plebani, Mario.
  • Padoan A; Department of Medicine-DIMED, Medical School, University of Padova, Italy; Department of Laboratory Medicine, University-Hospital of Padova, Italy.
  • Bonfante F; Laboratory of Experimental Animal Models, Division of Comparative Biomedical Sciences, Istituto Zooprofilattico Sperimentale delle Venezie, Legnaro, Italy.
  • Pagliari M; Laboratory of Experimental Animal Models, Division of Comparative Biomedical Sciences, Istituto Zooprofilattico Sperimentale delle Venezie, Legnaro, Italy.
  • Bortolami A; Laboratory of Experimental Animal Models, Division of Comparative Biomedical Sciences, Istituto Zooprofilattico Sperimentale delle Venezie, Legnaro, Italy.
  • Negrini D; Department of Medicine-DIMED, Medical School, University of Padova, Italy.
  • Zuin S; Department of Medicine-DIMED, Medical School, University of Padova, Italy.
  • Bozzato D; Department of Medicine-DIMED, Medical School, University of Padova, Italy; Department of Laboratory Medicine, University-Hospital of Padova, Italy.
  • Cosma C; Department of Laboratory Medicine, University-Hospital of Padova, Italy.
  • Sciacovelli L; Department of Laboratory Medicine, University-Hospital of Padova, Italy.
  • Plebani M; Department of Medicine-DIMED, Medical School, University of Padova, Italy; Department of Laboratory Medicine, University-Hospital of Padova, Italy. Electronic address: mario.plebani@unipd.it.
EBioMedicine ; 62: 103101, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-1023542
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
ABSTRACT

BACKGROUND:

Reliable high-throughput serological assays for SARS-CoV-2 antibodies are urgently needed for the effective containment of the COVID-19 pandemic, as it is of crucial importance to understand the strength and duration of immunity after infection, and to make informed decisions concerning the activation or discontinuation of physical distancing restrictions.

METHODS:

In 184 serum samples from 130 COVID-19 patients and 54 SARS-CoV-2 negative subjects, the analytical and clinical performances of four commercially available chemiluminescent assays (Abbott SARS-Cov-2 IgG, Roche Elecsys anti-SARS-CoV-2, Ortho SARS-CoV-2 total and IgG) and one enzyme-linked immunosorbent assay (Diesse ENZY-WELL SARS-CoV-2 IgG) were evaluated and compared with the neutralization activity achieved using the plaque reduction neutralization test (PRNT).

FINDINGS:

Precision results ranged from 0.9% to 11.8% for all assays. Elecsys anti-SARS-CoV-2 demonstrated linearity of results at concentrations within the cut-off value. Overall, sensitivity ranged from 78.5 to 87.7%, and specificity, from 97.6 to 100%. On limiting the analysis to samples collected 12 days after onset of symptoms, the sensitivity of all assays increased, the highest value (95.2%) being obtained with VITRO Anti-SARS-CoV-2 Total and Architect SARS-CoV-2 IgG. The strongest PRNT50 correlation with antibody levels was obtained with ENZY-Well SARS-CoV-2 IgG (R2adj = 0.569).

INTERPRETATION:

The results confirmed that all immunoassays had an excellent specificity, whereas sensitivity varied across immunoassays, depending strongly on the time interval between symptoms onset and sample collection. Further studies should be conducted to achieve a stronger correlation between antibody measurement and PRNT50 in order to obtain useful information for providing a better management of COVID-19 patients, effective passive antibody therapy, and developing a vaccine against the SARS-CoV-2 virus.

FUNDING:

None.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: EBioMedicine Year: 2020 Document Type: Article Affiliation country: J.ebiom.2020.103101

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: EBioMedicine Year: 2020 Document Type: Article Affiliation country: J.ebiom.2020.103101