Diagnostic technology for COVID-19: comparative evaluation of antigen and serology-based SARS-CoV-2 immunoassays, and contact tracing solutions for potential use as at-home products

  1. Mehdi Jorfi
  2. Nell Meosky Luo
  3. Aditi Hazra
  4. Fanny Herisson
  5. Glenn Miller
  6. James A. Toombs
  7. David R. Walt
  8. Paolo Bonato
  9. Rushdy Ahmad
  10. COVID-19 Direct-to-Consumer Task Force Investigators

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Abstract

As the United States prepares to return to work and open up the economy in the midst of the COVID-19 pandemic without an available vaccine or effective therapy, testing and contact tracing are essential to contain and limit the spread of the COVID-19 virus. In response to the urgent public health need for accurate, effective, low-cost, and scalable COVID-19 testing technology, we evaluated and identified diagnostic solutions with potential for use as an at-home product. We conducted a deep horizon scan for antigen and serology-based diagnostics and down-selected to the most promising technologies. A total of 303 candidate products (138 antibody and 44 antigen tests) were identified. Product evaluations were based entirely on company-provided data. 73 serology-based antibody tests passing an initial scoring algorithm based on specificity and sensitivity data were then further evaluated using a second scoring algorithm. This second algorithm included a review of additional technical specifications of the devices, an analysis of supply chain, manufacturing, and distribution capacity of each vendor. 24 potential antibody products met the selection criteria for further direct laboratory evaluation. The performance metrics for selection of these 24 products are currently being evaluated in a Mass General Brigham laboratory. Testing alone might not be sufficient to prevent the spread of a highly contagious disease like COVID-19. Manual contact tracing could complement testing, but it is likely to fail in identifying many individuals who were in contact with a given COVID patient. The proliferation of smartphones in the population has enabled the development of solutions that can provide public health officials with valuable information for rapid and accurate contact tracing. Besides, electronic-based contact tracing solutions can be augmented by symptom self-reports gathered using electronic patient reported outcome (ePRO) platforms and by physiological data collected using wearable sensors. We performed a detailed assessment of 12 ePRO solutions, 27 wearable sensors, and 44 electronic-based contact tracing solutions. These technologies were evaluated using criteria developed to assess their suitability to address the COVID-19 pandemic. We identified a number of solutions that could augment if not provide a more effective alternative to manual contact tracing. Finally, we propose a theoretical framework in which ePRO platforms, wearable sensors, and electronic-based contact tracing solutions would be utilized in combination with molecular and serological tests to identify and isolate COVID-19 cases rapidly.

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  1. ScreenIT

    SciScore for 10.1101/2020.06.25.20140236: (What is this?)

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

    Table 1: Rigor

    NIH rigor criteria are not applicable to paper type.

    Table 2: Resources

    No key resources detected.

    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:
    Limitations of our evaluation of antibody testing include sparse validation data of the technology, concern over potential false positives due to cross-reactivity with other human coronaviruses (HCoV-229E, NL63 or OC43), SARS, or MERS, and a lack of published data on the relationship between SARS-CoV-2 antibody positivity and protection. Negative results may not rule out SARS-CoV-2 infection. Simulation exercises on sensitivity and specificity metrics needed for herd immunity in the population were proposed, but modeling results was not available as of April 6, 2020. Future directions by the Diagnostics Accelerator include a detailed evaluation of DTC tests. Large-scale, longitudinal population-based validation studies with data on symptom-free days and contact tracing are needed better to characterize the accuracy of DTC antibody tests for SARS-CoV-2, to understand the prevalence of SARS-CoV-2 exposure among healthcare workers and the general population and elucidate the duration of protection. Our aims for the horizon scan were two primary objectives: (1) to establish a comprehensive list of currently available COVID-19 tests with the potential to be administered in a DTC setting; and (2) to develop a framework for filtering and ranking tests, to identify top candidates for further study (both now and in the future, as tests emerge). First, we assembled a team of investigators to identify potential test candidates, develop a scoring methodology by which to assess them, and ...

    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.

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  2. Version published to 10.1101/2020.06.25.20140236v1 on medRxiv