A serological assay to detect SARS-CoV-2 antibodies in at-home collected finger-prick dried blood spots

  1. Donna Grace Karp
  2. Kenneth Danh
  3. Noemi Fonseca Espinoza
  4. David Seftel
  5. Peter V. Robinson
  6. Cheng-ting Tsai

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Abstract

Accurate surveillance of coronavirus disease 2019 (COVID-19) incidence requires large-scale testing of the population. Current testing methods require in-person collection of biospecimens by a healthcare worker, limiting access of individuals who do not have access to testing facilities while placing both patients and healthcare workers at risk of exposure to infection. We report the development and validation of a at-home finger-prick dried blood spot collection kit and an analysis method. We demonstrated 100% sensitivity and specificity using at-home collected specimens across the US. Such methods may facilitate the conduct of unbiased serosurveys within hard to reach populations and help reduce the sample collection burden of serological testing on both health care systems and individuals alike.

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  1. Version published to 10.1038/s41598-020-76913-6
  2. ScreenIT

    SciScore for 10.1101/2020.05.29.20116004: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: All participants provided informed consent under the Western IRB approved IRB protocol #20180015 to Enable Biosciences.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    For the testing, the eluent was assayed using a modified Antibody Detection by Agglutination-PCR (ADAP) protocol12–14.
    ADAP
    suggested: None
    If present, the SARS-CoV-2 antibodies in the specimen engage with S1-DNA conjugate to agglutinate into a dense immune complex.
    SARS-CoV-2
    suggested: None
    Experimental Models: Cell Lines
    SentencesResources
    Materials: The SARS-CoV-2 spike protein (S1) containing amino acids 1–674 with an Fc-tag at the C-terminus (#31806), expressed in HEK293 cells, was purchased from the Native Antigen Company (Oxford, United
    HEK293
    suggested: CLS Cat# 300192/p777_HEK293, RRID:CVCL_0045)

    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.

    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.

  3. Version published to 10.1101/2020.05.29.20116004v2 on medRxiv
  4. Version published to 10.1101/2020.05.29.20116004v1 on medRxiv