Erytra blood group analyser and kode technology testing of SARS‐CoV‐2 antibodies among convalescent patients and vaccinated individuals

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Abstract

Surveillance of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic requires tests to monitor antibody formation and prevalence. We detected SARS‐CoV‐2 antibodies using red cells coated by Kode technology with short peptides derived from the SARS‐CoV‐2 spike protein (SP). Such modified red cells, called C19‐kodecytes, can be used as reagent cells in any manual or automated column agglutination assay. We investigated the presence of SARS‐CoV‐2 antibodies in 130 samples from COVID‐19 convalescent plasma donors using standard manual technique, two FDA‐authorized enzyme‐linked immunosorbent assay (ELISA) assays and a virus neutralisation assay. The sensitivity of the C19‐kodecyte assay was 88%, comparable to the anti‐SP and anti‐nucleocapsid protein (NCP) ELISAs (86% and 83%) and the virus neutralisation assay (88%). The specificity of the C19‐kodecyte assay was 90% (anti‐SP 100% and anti‐NCP 97%). Likewise, 231 samples from 73 vaccinated individuals were tested with an automated analyser, and we monitored the appearance and persistence of SARS‐CoV‐2 antibodies. The C19‐kodecyte assay is a robust tool for SARS‐CoV‐2 antibody detection. Automated blood group analyser use enables large‐scale SARS‐CoV‐2 antibody testing for vaccination monitoring in population surveys.

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  1. SciScore for 10.1101/2021.08.26.21262219: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsConsent: 1 Plasma samples from SARS-CoV-2 vaccination screening programme: Informed consent was obtained and individuals were tested for antibodies against SARS-CoV-2 prior to and after vaccination.
    IRB: This study was approved by the ethics board of the University of Ulm (no. 488/20).
    Sex as a biological variablenot detected.
    RandomizationCOVID-19-convalescent donor and control samples: Serum samples were sourced from blood donors who had recovered from mild to moderate PCR-confirmed COVID-19 disease and assessed as donors for convalescent plasma for a randomized prospective trial for treatment of patients with severe COVID-19 (CAPSID; EudraCT no. 2020-001310-38;
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    An antibody screening test with antiglobulin cards was done against C19-kodecytes, untreated control cells (being the same cell as used to make the kodecytes), a 3-cell pool of antibody screening reagent cells and an autocontrol (patient’s own cells).
    antiglobulin cards was done against C19-kodecytes
    suggested: None

    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: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04433910CompletedA Clinical Trial of Convalescent Plasma Compared to Best Sup…


    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.


    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.