Evaluation of eleven immunochromatographic assays for SARS-CoV-2 detection: investigating the dengue cross-reaction

  1. Beatriz Araujo Oliveira
  2. Lea Campos de Oliveira
  3. Franciane Mendes de Oliveira
  4. Geovana Maria Pereira
  5. Regina Maia de Souza
  6. Erika Regina Manuli
  7. Fabricio Klerynton Marchini
  8. Evelyn Patrícia Sanchez Espinoza
  9. Marcelo Park
  10. Leandro Taniguchi
  11. Pedro Vitale Mendes
  12. Lucas Augusto Moyses Franco
  13. Ana Catharina Nastri
  14. Maura Salaroli de Oliveira
  15. José Mauro Vieira Junior
  16. Esper Georges Kallas
  17. Anna Sara Levin
  18. Ester Cerdeira Sabino
  19. Silvia Figueiredo Costa

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Abstract

No abstract available

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  1. Version published to 10.1590/s1678-9946202264063
  2. ScreenIT

    SciScore for 10.1101/2020.10.09.20210039: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: 2.2 Ethical approval: This study was approved by the Brazilian national ethics review board (CONEP), protocol number 30701920200000068.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    To evaluate the cross reactivity with Dengue we analyzed 20 samples collected from patients with confirmed diagnosis for Dengue by ELISA technique between February and March/2019. 2.4 Immunochromatographic assays for antibodies against SARS-CoV-2: In this study positive and negative samples from Brazilian subjects were evaluated through eleven qualitative IC assays performed according to manufacturer instructions summarized at table 1, using the following kits: One Step COVID-19 test (Wondfo, China – batch W19500341); SARS-COV-2 (COVID-19) IgG/IgM Antibody Fast Detection (Thermogenesis, China – batch SYG202010); SARS-COV-2 IgM/IgG Antibody Test Kit (Luxus, China – batch SYG202010); COVID-19 IgM/IgG Rapid Test Kit (Camtech, Singapore – batch NF3170); Rapid test COVID-19 IgG/IgM BIO (Bioclin, Brazil – batch 0010); SARS-CoV-2 IgG / IgM Rapid Test Kit (TBG, Taiwan – batch FRS20041K); COVID-19 IgG/IgM ECO TEST (Ecotest, Brazil – batch 202005043); MedTest Coronavírus (COVID) IgG/IgM (MedTest, China – batch COV20030081); SARS-Cov-2 antibody detection test (Lepu, China – batch 20CG2518X); Kit COVID-19 IgG/IgM LF (Advagen, Brazil – batch L20183-02) and COVID-19 (SARS-CoV-2) IgM/IgG antibody Test kit (MedNet Wuhan, China – batch 20030501).
    SARS-CoV-2) IgM/IgG
    suggested: None
    2.5 Cross-reactivity between Dengue and COVID-19 serology: To evaluate the cross-reactivity of COVID-19 disease and Dengue serology, 20 samples of confirmed Dengue cases diagnosed through ELISA technique on early 2019 were evaluated using four IC assays for detection of antibodies against SARS-CoV-2: One Step COVID-19 test (Wondfo, China – batch W19500341), COVID-19 IgM/IgG Rapid Test Kit (Camtech, Singapore – batch NF3170), Kit COVID-19 IgG/IgM LF (Advagen, Brazil – batch L20183-02) and IgM/IgG antibody Test kit (MedNet Wuhan, China – batch 20030501) according to manufacturer instructions.
    IgM/IgG
    suggested: (Creative Diagnostics Cat# DMABRM011T, RRID:AB_2528351)
    We also evaluated the cross-reactivity using IC assays for detection of antibodies against Dengue in 33 samples of COVID-19 confirmed cases using ALERE DENGUE DUO-NS1 IgG and IgM (Abbott, USA – batch 11DDE008A-A and 11DDE007A-A).
    IgM
    suggested: None
    Software and Algorithms
    SentencesResources
    We also evaluated the cross-reactivity using IC assays for detection of antibodies against Dengue in 33 samples of COVID-19 confirmed cases using ALERE DENGUE DUO-NS1 IgG and IgM (Abbott, USA – batch 11DDE008A-A and 11DDE007A-A).
    Abbott
    suggested: (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: We detected the following sentences addressing limitations in the study:
    Our study has limitations such as sample size; however, to our knowledge it was the first study that analyzed several SARS-CoV-2 IC tests and cross-reaction with Dengue. Thus, our findings can be useful in countries with high prevalence of Dengue to alert to the possible cross-reactivity of the SARS-CoV-2 IC assays, mainly IgM, with Dengue antibodies.

    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 10.1101/2020.10.09.20210039v1 on medRxiv