COVID-19 Antibody Detection and Assay Performance Using Red Cell Agglutination
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Abstract
We recently developed a red cell based assay to detect SARS-CoV-2 antibodies in human plasma. In the current study, we show the hands-on application of this assay in a group of COVID-19 convalescent plasma donors and healthy individuals.
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SciScore for 10.1101/2021.06.09.21258232: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Institutional Review Board (IRB) approved protocols were NCT04360278, NCT00001846 and NCT00067054, respectively, which entailed written informed consent.
Consent: Institutional Review Board (IRB) approved protocols were NCT04360278, NCT00001846 and NCT00067054, respectively, which entailed written informed consent.
Field Sample Permit: The plasma controls from 2008 were collected under the Vaccine Research Center’s (VRC), National Institutes of Allergy and Infectious Diseases (Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Anti-SARS-CoV-2 assays: Two chemiluminescent … SciScore for 10.1101/2021.06.09.21258232: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Institutional Review Board (IRB) approved protocols were NCT04360278, NCT00001846 and NCT00067054, respectively, which entailed written informed consent.
Consent: Institutional Review Board (IRB) approved protocols were NCT04360278, NCT00001846 and NCT00067054, respectively, which entailed written informed consent.
Field Sample Permit: The plasma controls from 2008 were collected under the Vaccine Research Center’s (VRC), National Institutes of Allergy and Infectious Diseases (Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Anti-SARS-CoV-2 assays: Two chemiluminescent immunoassays directed against the SARS-CoV-2 spike glycoprotein, Ortho IgG (80.8% overall sensitivity and 98.1% overall specificity) [15], and Ortho Total (IgG, IgA and IgM; 87.7% overall sensitivity and 95.2% overall specificity) [15] (Ortho Clinical Diagnostics, Raritan, NJ, USA), authorized by FDA under an EUA for use by laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), were used to detect total binding antibodies against the SARS-CoV-2 virus in all 140 CCP donors [14, 15]. SARS-CoV-2 spike glycoprotein , Ortho IgGsuggested: NoneResults 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: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04360278 Recruiting Plasma Collection From Convalescent and/or Immunized Donors … NCT00001846 Recruiting Collection and Distribution of Blood Components From Healthy… NCT00067054 Recruiting Apheresis and Specimen Collection Procedures to Obtain Plasm… 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.
Results from scite Reference Check: We found no unreliable references.
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