COVID-19 Rapid Antigen Test as Screening Strategy at Points of Entry: Experience in Lazio Region, Central Italy, August–October 2020

  1. Francesca Colavita
  2. Francesco Vairo
  3. Silvia Meschi
  4. Maria Beatrice Valli
  5. Eleonora Lalle
  6. Concetta Castilletti
  7. Danilo Fusco
  8. Giuseppe Spiga
  9. Pierluigi Bartoletti
  10. Simona Ursino
  11. Maurizio Sanguinetti
  12. Antonino Di Caro
  13. Francesco Vaia
  14. Giuseppe Ippolito
  15. Maria Rosaria Capobianchi

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Abstract

COVID-19 pandemic is a dramatic health, social and economic global challenge. There is urgent need to maximize testing capacity. Rapid Antigen Tests (RAT) represent good candidates for point-of-care and mass surveillance testing to rapidly identify SARS-CoV-2-infected people, counterbalancing lower sensitivity vs. gold standard molecular tests with fast results and possible recurrent testing. We describe the results obtained with the testing algorithm implemented at points of entry (airports and ports) in the Lazio Region (Italy), using the STANDARD F COVID-19 Antigen Fluorescence ImmunoAssay (FIA), followed by molecular confirmation of FIA-positive samples. From mid-August to mid-October 2020, 73,643 RAT were reported to the Regional Surveillance Information System for travelers at points of entry in Lazio Region. Of these, 1176 (1.6%) were FIA-positive, and the proportion of RT-PCR-confirmed samples was 40.5%. Our data show that the probability of confirmation was directly dependent from the semi-quantitative FIA results. In addition, the molecularly confirmed samples were those with high levels of virus and that were actually harboring infectious virus. These results support public health strategies based on early mass screening campaigns by RAT in settings where molecular testing is not feasible or easily accessible, such as points of entry. This approach would contribute to promptly controlling viral spread through travel, which is now of particular concern due to the spread of SARS-CoV-2 variants.

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  1. Version published to 10.3390/biom11030425
  2. ScreenIT

    SciScore for 10.1101/2020.11.26.20232728: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: This work was performed within the framework of the COVID-19 outbreak response and surveillance program, and has been approved by the INMI Ethical Committee (“Comitato
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    Virus culture was performed on selected RT-PCR confirmed samples, using Vero E6 cell line, as previously described [15].
    Vero E6
    suggested: RRID:CVCL_XD71)
    Software and Algorithms
    SentencesResources
    Anonymized data have been extracted and analyzed using STATA 14 statistical software.
    STATA
    suggested: (Stata, RRID:SCR_012763)
    Spearman correlation test was performed using GraphPad Prism version 8.00 (GraphPad 160 Software, US).
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)
    Positive Predictive value (PPV) and negative predictive value (NPV) were calculated using the MedCalc statistical software (MedCalc Software Ltd, Belgium).
    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: We detected the following sentences addressing limitations in the study:
    A limitation of the present study is that Ag RDTs resulted negative at PoE did not undergo RT-PCR testing, so it was not possible to estimate the proportion of PCR-positive samples missed by Ag RDT. However, in our opinion, though Ag RDTs are substantially less sensitive than NAAT [8], they are worth to be integrated into COVID-19 outbreak management programs, as they may contribute to the prompt isolation of highly infectious cases who would otherwise have been lost, highlighting the role of PoE testing as a pillar of outbreak control [11; 18]. In fact, the use of Ag RDT may be particularly advantageous to early minimize the risk of the virus spreading, especially when and where there is no immediate access to RT-PCR testing, or where this cannot be feasible, as for mass and frequent testing or in certain field settings. In addition, Ag RDT use could also represent a suitable screening tool for prompt cluster investigation and in specific cohorts such as asymptomatic contacts of COVID-19 confirmed cases, pauci-symptomatic patients with no epidemiological link and travelers with no symptoms [11]. Of course, public-awareness campaigns must also communicate that a negative Ag RDT does not necessarily implies a clean bill of health, and continued social distancing and mask wearing needs to be recommended. In addition, negative Ag RDT results in symptomatic patients should not be considered definitive, and molecular tests are required for a more reliable diagnostic assessment. Fi...

    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

    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 10.1101/2020.11.26.20232728v1 on medRxiv