Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17 th of August, 2021

  1. Gabriel Hawthorne
  2. Adam Harvey

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Abstract

Point-of-care assays offer a decentralized and fast solution to the diagnosis of SARS-CoV-2, providing benefits for patients, healthcare workers and healthcare facilities. This technology has the potential to prevent outbreaks, enable fast adoption of potentially life-saving measures and improve hospital workflow. While reviews regarding the laboratory performance of those assays exist, a review focused on the real-life clinical performance and true point-of-care feasibility of those platforms is missing. Therefore, the objective of this study is to help clinicians, healthcare providers and organizations to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities, or inside hospitals. 1246 studies were screened in 3 databases and 87 studies were included, evaluating 27 antigen tests and 11 nucleic-acid amplification platforms deemed feasible for true point-of-care placement. We excluded studies that used processed samples, pre-selected populations, archived samples and laboratory-only evaluations and strongly favored prospective trial designs. We also investigated package inserts, instructions for use, comments on published studies and manufacturer’s websites in order to assess feasibility of point-of-care placement and additional information of relevance to the end-user. Apart from performance in the form of sensitivity and specificity, we present information on time to results, hands-on time, kit storage, machine operating conditions and regulatory status. To the best of our knowledge, this is the first review to systematically compare point-of-care test performance in real-life clinical practice. We found the performance of tests in clinical practice to be markedly different from the manufacturers reported performance and laboratory- only evaluations in the majority of scenarios. Our findings may help in the decision-making process related to SARS-CoV-2 test in real-life clinical settings.

Rationale for the review

A review focused on the real-life clinical performance and point-of-care feasibility of SARS-CoV-2 diagnostic platforms is missing, impairing the ability of individuals, healthcare providers and test providers to make informed decisions.

Objective(s) or question(s) the review addresses

The objective of this study is to help clinicians, healthcare providers and organizations to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities or in complex healthcare environments.

Article activity feed

  1. Version published to 10.1101/2021.09.20.21263509v2 on medRxiv
  2. ScreenIT

    SciScore for 10.1101/2021.09.20.21263509: (What is this?)

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

    Table 1: Rigor

    EthicsField Sample Permit: After debate between the authors, a broad search phrase was defined with the intention to capture a large number of studies, given the novelty of the field.
    Sex as a biological variablenot detected.
    RandomizationOn the other hand, studies that complemented a prospective evaluation by testing positive populations in a randomized way were accepted, provided the proportion was reasonable.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    2.1 Search strategy: MEDLINE database was searched on 04/04/2021 for 345 results.
    MEDLINE
    suggested: (MEDLINE, RRID:SCR_002185)
    BioRxiv database was searched on 04/04/2021 for 54 results.
    BioRxiv
    suggested: (bioRxiv, RRID:SCR_003933)
    For instance, the study of Tu et al24 evaluating the ID NOW platform (Abbott) had an original design to enroll 200 positive patients, but a prevalence drop made the study unaffordable.
    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:
    4.3 Limitations: One of the main limitations of this review is the selection criteria. Considering the high heterogeneity of methods and outcomes between studies, finding a clear-cut unified exclusion criteria was not possible. We debated between authors when in doubt, but a level of subjectivity was inevitable. For the same reasons of heterogeneity, we opted not to conduct a meta-analysis in this study. Authors have decided against providing an ‘average’ performance for platforms as this would likely be misleading and would potentially downplay the method discrepancies in the trials.

    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.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.09.20.21263509v1 on medRxiv