Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care

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Abstract

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  1. SciScore for 10.1101/2020.11.13.20231316: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: All potentially eligible participants were asked to sign an informed consent document and to answer a short questionnaire that asked about the reasons for RT-PCR testing (referral by a GP due to symptoms, close contact, others); socio-demographic information (sex and age); and the presence of symptoms, type of symptoms, and number of days since symptom onset or close contact to a positive SAR-CoV-2 patient.
    IRB: Ethics and funding: This study was conducted following the Declaration of Helsinki and was approved by the Balearic Research Ethics Committee (IB 4350/20 PI on 30/09/2020) and by the Mallorca Primary Care Research Commission.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical calculations were performed using Stata 13 (StataCorp, College Station, TX, USA) with the Stata DIAGT module.
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    Results from OddPub: Thank you for sharing your data.


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Strengths and limitations: The present study is the largest evaluation of the Panbio Ag-RDT in samples from symptomatic and asymptomatic patients in real-world context. This is a strength of our study because this is the setting where the majority of the patients with mild symptoms (up to 75%)(12) and close contacts are visited and followed-up. We incorporated COVID-19 testing into the usual care and management of patients with suspected SARS-CoV-2 infection and less than 2% of participants denied taking part in the study. Our study has several limitations. We only assessed one type of Ag-RDT that targeted the SARS-CoV-2 N (nucleocapsid) protein, although other tests are available. Also, we only examined two types of testing scenarios —referral by a GP based on symptoms and close contact with a confirmed case — and therefore cannot make inferences about the applicability of this test in other scenarios (screening of nursing-homes, workplaces, etc.). Additional rigorous studies are needed to establish the optimal performance characteristics for Ag-RDTs that have different protein targets, are employed in different specific settings, and that have different pretest probabilities. There is no standardized method to establishing the infectiousness of a patient with confirmed SARS-CoV-2 based on viral load. Ct values can vary among studies according to the type of test and target gene. We considered low viral load as a Ct value above 30 in patients with positive RT-PCR results (13...

    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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