Diagnostic accuracy of six commercial SARS-CoV-2 IgG/total antibody assays and identification of SARS-CoV-2 neutralizing antibodies in convalescent sera
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Abstract
The reliable detection of immunoglobulin G (IgG) or total antibodies directed against the novel severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is important for clinical diagnostics and epidemiological studies.
Here, we compare the diagnostic accuracy of six commercially available SARS-CoV-2 IgG (Abbott SARS-CoV-2 IgG; Diasorin Liaison ® SARS-CoV-2 S1/2 IgG; Epitope EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit; Euroimmun Anti-SARS-CoV-2 ELISA (IgG); Mikrogen recom Well SARS-CoV-2 IgG) or total SARS-CoV-2 antibody assays (Roche Elecsys Anti-SARS-CoV-2).
The test sensitivities were analyzed with a set of 34 sera obtained from 26 patients after PCR-confirmed SARS-CoV-2 infection and varied from 76.9% (Euroimmun) to 96.2% (Abbott). The majority of assay results were confirmed in a laboratory-developed plaque reduction neutralization test and by a SARS-CoV-2 IgG-specific line assay including measurement of generally low IgG avidities (Mikrogen recom Line Coronavirus IgG [Avidität], prototype).
Moreover, 100 stored sera collected during summer 2018 (N = 50) and winter season 2018/2019 (N = 50) were included to demonstrate test specificities. These varied from 96.0% (DiaSorin) to 100% (Epitope EDI™).
A subset of sera were retested with a lateral flow test (STANDARD Q COVID-19 IgM/IgG Duo) and a considerably lower sensitivity was noted.
Overall, the diagnostic accuracy of the six SARS-CoV-2 IgG/total antibody assays was good and varied from 92.9% (Euroimmun) to 98.4% (Abbott). Due to the different specificities, results of commercially available SARS-CoV-2 antibody tests should be interpreted with caution. A high proportion of antibody-positive patient sera demonstrated neutralizing capacity against SARS-CoV-2.
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SciScore for 10.1101/2020.06.15.20131672: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The Ethics committee of the Medical Faculty of the Kiel University approved the setting of this study (AZ D467/20). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources These samples should contain SARS-CoV-2 IgG/total antibodies and, therefore, were considered to determine serological assay sensitivities. SARS-CoV-2 IgG/totalsuggested: NoneGermany; Mikrogen recomWell SARS-CoV-2 IgG, Mikrogen GmbH, Neuried, Germany) as well as one total SARS-CoV-2 antibody test (Roche Elecsys Anti-SARS-CoV-2 SARS-CoV-2suggested: NoneSciScore for 10.1101/2020.06.15.20131672: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The Ethics committee of the Medical Faculty of the Kiel University approved the setting of this study (AZ D467/20). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources These samples should contain SARS-CoV-2 IgG/total antibodies and, therefore, were considered to determine serological assay sensitivities. SARS-CoV-2 IgG/totalsuggested: NoneGermany; Mikrogen recomWell SARS-CoV-2 IgG, Mikrogen GmbH, Neuried, Germany) as well as one total SARS-CoV-2 antibody test (Roche Elecsys Anti-SARS-CoV-2 SARS-CoV-2suggested: NoneExemplarily, 18 sera were retested in a rapid lateral flow assay that distinguishes SARS-CoV-2 IgG- and IgM-antibodies (STANDARD Q COVID-19 IgM/IgG Duo, SD Biosensor, Suwon-si, Republic of Korea). SARS-CoV-2 IgG-suggested: NoneExperimental Models: Cell Lines Sentences Resources Forty-seven sera were also tested under biosafety level 3 conditions in a plaque reduction neutralization assay (PRNT) using an own SARS-CoV-2 isolate (M16502) and Vero cells (order no. 605372, CLS Cell Lines Service GmbH, Eppelheim, Germany). Verosuggested: NoneSoftware and Algorithms Sentences Resources All tests were conducted strictly following the recommendations of the manufacturers on an Architect (Abbott), a Liaison XL (DiaSorin), a Cobas e 411 (Roche) or for the assays of Epitope, Euroimmun and Mikrogen on the BEP 2000 system (Siemens Healthcare GmbH, Erlangen, Germany), respectively. Abbottsuggested: (Abbott, RRID:SCR_010477)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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