An evaluation of COVID-19 serological assays informs future diagnostics and exposure assessment
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Abstract
The world is entering a new era of the COVID-19 pandemic in which there is an increasing call for reliable antibody testing. To support decision making on the deployment of serology for either population screening or diagnostics, we present a detailed comparison of serological COVID-19 assays. We show that among the selected assays there is a wide diversity in assay performance in different scenarios and when correlated to virus neutralizing antibodies. The Wantai ELISA detecting total immunoglobulins against the receptor binding domain of SARS CoV-2, has the best overall characteristics to detect functional antibodies in different stages and severity of disease, including the potential to set a cut-off indicating the presence of protective antibodies. The large variety of available serological assays requires proper assay validation before deciding on deployment of assays for specific applications.
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SciScore for 10.1101/2020.04.23.20077156: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethical clearance: The use of specimen from the Netherlands was approved by the local medical ethical committee (MEC approval: 2014–414) Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Rapid antibody test: The rapid tests we evaluated are 1) Rapid SARS -CoV-2 Antibody (IgM/IgG) Test from InTec utilizing the nucleocapsid protein as antigen (Test of lot S2020021505), 2) the qSARS-CoV-2 IgG/IgM Cassette Rapid Test (GICA) from Cellex Inc. Antibody (IgM/IgGsuggested: (Creative Diagnostics Cat# DMABRM011T, RRID:AB_2528351)Software and Algorithms Sentence… SciScore for 10.1101/2020.04.23.20077156: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethical clearance: The use of specimen from the Netherlands was approved by the local medical ethical committee (MEC approval: 2014–414) Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Rapid antibody test: The rapid tests we evaluated are 1) Rapid SARS -CoV-2 Antibody (IgM/IgG) Test from InTec utilizing the nucleocapsid protein as antigen (Test of lot S2020021505), 2) the qSARS-CoV-2 IgG/IgM Cassette Rapid Test (GICA) from Cellex Inc. Antibody (IgM/IgGsuggested: (Creative Diagnostics Cat# DMABRM011T, RRID:AB_2528351)Software and Algorithms Sentences Resources Results were analyzed using GraphPad Prism version 8 (https://www.graphpad.com) and sensitivity/specificity were calculated. GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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