Clinical Validation and Performance Evaluation of the Automated Vitros Total Anti–SARS-CoV-2 Antibodies Assay for Screening of Serostatus in COVID-19

  1. Emily Garnett
  2. Joanna Jung
  3. Estella Tam
  4. Deepthi Rajapakshe
  5. Stephen Cheney
  6. Cameron Brown
  7. Jing Cao
  8. Kenneth Muldrew
  9. Ila Singh
  10. James Versalovic
  11. Sridevi Devaraj

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Abstract

Objectives

Evaluation of serostatus against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as an important tool in identification of exposure to coronavirus disease 2019 (COVID-19). We report on the validation of the Vitros Anti–SARS-CoV-2 Total (CoV2T) assay for qualitative serologic testing of SARS-CoV-2 antibodies.

Methods

We performed validation studies according to Commission of Office Laboratories Accreditation guidelines, using samples previously tested for SARS-CoV-2 by reverse transcription–polymerase chain reaction (RT-PCR). We evaluated precision, analytical interferences, and cross-reactivity with other viral infections; evaluated concordance with molecular and other serologic testing; and evaluated seroconversion.

Results

The Vitros CoV2T assay exhibited acceptable precision and did not exhibit cross-reactivity with other acute respiratory virus infections. The CoV2T assay exhibited 100% negative predictive agreement (56/56) and 71% positive predictive agreement (56/79) with RT-PCR across all patient samples and was concordant with other serologic assays. Concordance with RT-PCR was 97% more than 7 days after symptom onset. The CoV2T assay was robust to icterus and lipemia but had interference from significant hemolysis.

Conclusions

The Vitros CoV2T assay was successfully validated in our laboratory. We anticipate it will be a useful tool in screening for exposure to SARS-CoV-2; however, the use of the CoV2T and other serologic assays in the clinical management of patients with COVID-19 is unknown and must be evaluated in future studies.

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  1. Version published to 10.1093/ajcp/aqaa157
  2. ScreenIT

    SciScore for 10.1101/2020.06.09.20126474: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Specimens for validation were obtained under informed consent from healthy volunteers and from known COVID-19 patients, under an approved protocol from the Baylor College of Medicine Institutional Review Board (H47459)
    IRB: Specimens for validation were obtained under informed consent from healthy volunteers and from known COVID-19 patients, under an approved protocol from the Baylor College of Medicine Institutional Review Board (H47459)
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The CoV2T assay uses a solid-phase SARS-CoV-2 spike protein antigen to capture antibodies in the patient specimen, and horseradish peroxidase-labeled recombinant SARS-CoV-2 antigen as a detection reagent.
    SARS-CoV-2 spike protein antigen to capture
    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: 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

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  3. Version published to 10.1101/2020.06.09.20126474v1 on medRxiv