Acceptable performance of the Abbott ID NOW among symptomatic individuals with confirmed COVID-19

  1. William Stokes
  2. Byron M. Berenger
  3. Takshveer Singh
  4. Ifueko Adeghe
  5. Angela Schneider
  6. Danielle Portnoy
  7. Teagan King
  8. Brittney Scott
  9. Kanti Pabbaraju
  10. Sandy Shokoples
  11. Anita A. Wong
  12. Kara Gill
  13. LeeAnn Turnbull
  14. Jia Hu
  15. Graham Tipples

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Abstract

Introduction. The ID NOW is FDA approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of symptom onset for COVID-19 if tested within 1 h of specimen collection.

Gap statement. Clinical data on the performance of the ID NOW are limited, with many studies varying in their study design and/or having small sample size.

Aim. In this study we aimed to determine the clinical performance of the ID NOW compared to conventional RT-PCR testing.

Methodology. Adults with COVID-19 in the community or hospital were recruited into the study. Paired throat swabs were collected, with one throat swab transported immediately in an empty sterile tube to the laboratory for ID NOW testing, and the other transported in universal transport media and tested by an in-house SARS-CoV-2 RT-PCR assay targeting the E gene.

Results. In total, 133 individuals were included in the study; 129 samples were positive on either the ID NOW and/or RT-PCR. Assuming any positive result on either assay represents a true positive, positive per cent agreement (PPA) of the ID NOW compared to RT-PCR with 95 % confidence intervals was 89.1 % (82.0–94.1%) and 91.6 % (85.1–95.9%), respectively. When analysing individuals with symptom duration ≤7 days and who had the ID NOW performed within 1 h ( n =62), ID NOW PPA increased to 98.2 %.

Conclusion. Results from the ID NOW were reliable, especially when adhering to the manufacturer’s recommendations for testing.

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  1. Version published to 10.1099/jmm.0.001372 on Access Microbiology
  2. ScreenIT

    SciScore for 10.1101/2020.12.24.20248786: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Oral consent by phone was obtained for collection of samples in the participant’s home or in a hospital (if hospitalized).
    IRB: The University of Calgary Research Ethics board approved this study (REB20-444).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Healthcare workers performing the collection were given instructions on how to perform throat swabs using the ClassiqSwabs (COPAN Diagnostics, California, United States) and the throat swab provided in the ID NOW testing kits (Abbott, Illinois, United States).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    Two hundred microliters of UTM were extracted on the MagMAX Express-96 or Kingfisher Flex (ABI) using the MagMAX-96 Viral RNA Isolation Kit (ThermoFisher) or the PurePrep Pathogen Kit (MolGen) according to manufacturer’s instructions, and eluted into a volume of 110ul.
    MolGen
    suggested: (MolGen, RRID:SCR_005700)
    Statistical analysis was performed using Pearson Chi-squared for categorical variables and t-test for continuous variables using STATA (version 14.1).
    STATA
    suggested: (Stata, RRID:SCR_012763)

    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 study include the low number of hospitalized patients recruited such that we cannot make strong conclusions about the ID NOW performance among this population. The majority of throat swabs tested on the ID NOW were collected before the comparator swab (78.0%). However, we did not observe any difference in ID NOW or RT-PCR positivity rate when comparing patients who had ID NOW throat swab collected first vs second (Table 5 and supplementary material). There were discrepancies between ID NOW positive, RT-PCR negative specimens, that could have resulted from multiple factors, such as intra-collector variability in the throat swab collections and degradation of virus during transportation/storage, as opposed to false positive ID NOW results. The strengths of our study include the large number of COVID-19 positive individuals recruited, particularly those residing within the community. We adhered to the manufacturer’s recommendations, as much as possible, to recruit COVID-19 positive individuals with symptoms ≤ 7 days at time of collection and to test samples on the ID NOW within an hour from collection. Adhering to these requirements was difficult, as it often took several days from symptom onset for an individual in the community to get swabbed and test results reported. Consequently, the symptom onset was often near seven days. Meeting the one-hour criteria was challenging as we had to drive back and forth from participants’ households to our laboratory, 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.

    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 10.1101/2020.12.24.20248786v1 on medRxiv