Clinical evaluation of an automated, rapid mariPOC antigen test in screening of symptomatics and asymptomatics for SARS‐CoV‐2 infection

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Abstract

A novel automated mariPOC SARS‐CoV‐2 antigen test was evaluated in a Health Care Center Laboratory among symptomatic and asymptomatic individuals seeking SARS‐CoV‐2 testing. According to the national testing strategy, reverse transcription polymerase chain reaction (RT‐PCR) was used as a reference method. A total of 962 subjects were included in this study, 4.8% (46/962) of their samples were SARS‐CoV‐2 RT‐PCR‐positive, and 87% (40/46) of these were from symptomatics. Among the symptomatics, the overall sensitivity of the mariPOC SARS‐CoV‐2 test was 82.5% (33/40), though the sensitivity increased to 97.1% (33/34) in samples with a C t  < 30. The mariPOC SARS‐CoV‐2 test detected two of six PCR‐positive samples among the asymptomatics, four cases that remained antigen test negative had C t values between 28 and 36. The specificity of the mariPOC SARS‐CoV‐2 test was 100% (916/916). The evaluation showed that the mariPOC SARS‐CoV‐2 rapid antigen test is very sensitive and specific for the detection of individuals who most probably are contagious.

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  1. SciScore for 10.1101/2022.04.22.22273686: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analysis: The mariPOC® SARS-CoV-2 rapid antigen test sensitivity, including 95% confidence intervals (CI), was determined using MedCalc Software [21].
    MedCalc
    suggested: (MedCalc, RRID:SCR_015044)

    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.

    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.