Evaluation of commercially available immuno‐magnetic agglutination in comparison to enzyme‐linked immunosorbent assays for rapid point‐of‐care diagnostics of COVID‐19

  1. Maria E. Moeller
  2. Jeppe Fock
  3. Pearlyn Pah
  4. Antia De La C. Veras
  5. Melanie Bade
  6. Marco Donolato
  7. Simone B. Israelsen
  8. Jesper Eugen‐Olsen
  9. Thomas Benfield
  10. Frederik N. Engsig

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Abstract

Introduction

Coronavirus disease 2019 (COVID‐19) is caused by Severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2). Fast, accurate, and simple blood‐based assays for quantification of anti‐SARS‐CoV‐2 antibodies are urgently needed to identify infected individuals and keep track of the spread of disease.

Methods

The study included 33 plasma samples from 20 individuals with confirmed COVID‐19 by real‐time reverse‐transcriptase polymerase chain reaction and 40 non‐COVID‐19 plasma samples. Anti‐SARS‐CoV‐2 immunoglobulin M (IgM)/immunoglobulin A (IgA) or immunoglobulin G (IgG) antibodies were detected by a microfluidic quantitative immunomagnetic assay (IMA) (ViroTrack Sero COVID IgM + IgA/IgG Ab, Blusense Diagnostics) and compared to an enzyme‐linked immunosorbent assay (ELISA) (EuroImmun Medizinische Labordiagnostika).

Results

Of the 33 plasma samples from the COVID‐19 patients, 28 were positive for IgA/IgM or IgG by IMA and 29 samples were positive by ELISA. Sensitivity for only one sample per patient was 68% for IgA + IgM and 75% IgG by IMA and 80% by ELISA. For samples collected 14 days after symptom onset, the sensitivity of both IMA and ELISA was around 91%. The specificity of the IMA reached 100% compared to 95% for ELISA IgA and 97.5% for ELISA IgG.

Conclusion

IMA for COVID‐19 is a rapid simple‐to‐use point‐of‐care test with sensitivity and specificity similar to a commercial ELISA.

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  1. Version published to 10.1002/jmv.26854
  2. ScreenIT

    SciScore for 10.1101/2020.08.15.20172080: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: A waiver of individual informed consent was granted by the Regional Ethics Committee of the Capital Region of Denmark (record no. H-20040649).
    IRB: A waiver of individual informed consent was granted by the Regional Ethics Committee of the Capital Region of Denmark (record no. H-20040649).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The magnetic particles were covalently coupled to antigens or antibodies.
    antigens
    suggested: None
    Software and Algorithms
    SentencesResources
    The plots including receiver operating characteristics (ROC)-curves were constructed in python using the matplotlib, seaborn and sklearn packages.
    matplotlib
    suggested: (MatPlotLib, RRID:SCR_008624)
    ; SPSS Inc., Chicago, Illinois, USA).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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: We detected the following sentences addressing limitations in the study:
    The limitation of a given sample producing a false negative result is correlated to different factors, such as, time of testing in relation to symptom onset, changes in antibody levels during illness and severity of the disease. Several studies covering the use of ELISA, Chemiluminescence immunoassays (CLIA) and qualitative assays show that full diagnostic sensitivity for neither IgM nor IgG is reached before approximately 14-22 days from onset of symptoms. [29,30,33-35], It has been reported that IgM detection was more variable than IgG, and detection was highest when IgM and IgG results were combined for both ELISA and POCs [27], The addition of IgA may improve sensitivity as it has been found to have higher titers than IgM [36]. Using IMA cartridges we observed a better performance of the IgA+lgM/IgG combination in terms of sensitivity while keeping the specificity at 100%. Two previous studies have shown that antibodies to the nucleocapside antigen can be measured earlier than antibodies to the spike protein antigen [37,38]. In this study we included test against both antibodies but found little difference. An explanation for this may be that the samples were taken at different timepoints and only five study subjects had serial sampling performed. Four of seven negative samples were taken less than 10 days before symptom onset. Studies have demonstrated that the median time for measurable antibodies following SARS-CoV-2 infection is five-seven days[ll,34], which possibly ...

    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 10.1101/2020.08.15.20172080 on medRxiv