Sensitivity of ID NOW and RT–PCR for detection of SARS-CoV-2 in an ambulatory population

Curation statements for this article:
  • Curated by eLife

    eLife logo

    Evaluation Summary:

    The authors evaluate the performance of the Abbott ID NOW SARS-CoV-2 test in a group of non-hospitalized individuals being tested for COVID-19 and compared that performance to an RT-PCR test. The authors also provide an interesting review and meta-analysis of ID NOW performance across the literature. The cohort assessed in this study, however, was small and localized, which currently undermines its comparison with the known performance of the test in broader applications.

    (This preprint has been reviewed by eLife. We include the public reviews from the reviewers here; the authors also receive private feedback with suggested changes to the manuscript. Reviewer #1 agreed to share their name with the authors.)

This article has been Reviewed by the following groups

Read the full article See related articles

Abstract

Diagnosis of SARS-CoV-2 (COVID-19) requires confirmation by reverse transcription–polymerase chain reaction (RT–PCR). Abbott ID NOW provides fast results but has been criticized for low sensitivity. Here we determine the sensitivity of ID NOW in an ambulatory population presented for testing. The study enrolled 785 symptomatic patients, of whom 21 were positive by both ID NOW and RT–PCR, and 2 only by RT–PCR. All 189 asymptomatic patients tested negative. The positive percent agreement between the ID NOW assay and the RT–PCR assay was 91.3%, and negative percent agreement was 100%. The results from the current study were included into a larger systematic review of literature where at least 20 subjects were simultaneously tested using ID NOW and RT–PCR. The overall sensitivity for ID NOW assay was calculated at 84% (95% confidence interval 55–96%) and had the highest correlation to RT–PCR at viral loads most likely to be associated with transmissible infections.

Article activity feed

  1. Response to Public Reviews

    Response to Reviewer #1 (Public Review):

    We thank the reviewer for their kind comments and were glad to learn that the reviewer felt the manuscript significantly contributed to body of knowledge on COVID-19.

    Response to Reviewer #2 (Public Review):

    We thank the reviewer for their dedication to a detailed review, and we greatly appreciated the constructive suggestions given that have helped strengthen the overall manuscript.

    We agree with the reviewer that the loss of power for detecting a loss of sensitivity by the ID NOW PCR assay was hindered by the overall low population frequency of COVID-19 disease; this resulted in a low number of positive patients and ultimately led to early study termination as a result. Because of the reviewer’s helpful observation, we have now re-estimated the power of this study …

  2. Reviewer #2 (Public Review):

    Tu et al. submit a manuscript that evaluates the performance of the Abbott ID NOW SARS-CoV-2 test in an ambulatory cohort relative to RT-PCR tests. They enrolled 785 symptomatic patients, 21 tested positive for SARS-CoV-2 by ID NOW and PCR (Hologic) while 2 tested positive only via PCR. They also tested 189 asymptomatic individuals, none of whom tested positive by either ID NOW or PCR. The positive agreement between ID NOW and PCR was 91.3%, and the negative percent agreement was 100%. The authors also provide a review and meta-analysis of ID NOW performance across at least a dozen other named studies which is thorough and interesting. The cohort assessed in this study is small and localized. The data is undermined by sample size, with the most glaring example being the 100% negative percent agreement, which …

  3. Reviewer #1 (Public Review):

    The study presents relatively high and robust sensitivity of Abbott ID NOW for the detection of SARS-CoV-2 (COVID-19) in an ambulatory population, utilizing the RT-PCR methodology as a comparative correlation. The study was well designed and enrolled both symptomatic and asymptomatic populations to provide sufficient statistical power for the comparative analysis of the methodologies, as well as to represent accurately the patient populations. This is a useful and timely study that has a great impact in clinical setting for the rapid detection of COVID-19.

  4. Evaluation Summary:

    The authors evaluate the performance of the Abbott ID NOW SARS-CoV-2 test in a group of non-hospitalized individuals being tested for COVID-19 and compared that performance to an RT-PCR test. The authors also provide an interesting review and meta-analysis of ID NOW performance across the literature. The cohort assessed in this study, however, was small and localized, which currently undermines its comparison with the known performance of the test in broader applications.

    (This preprint has been reviewed by eLife. We include the public reviews from the reviewers here; the authors also receive private feedback with suggested changes to the manuscript. Reviewer #1 agreed to share their name with the authors.)

  5. SciScore for 10.1101/2020.12.07.20245225: (What is this?)

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

    Table 1: Rigor

    NIH rigor criteria are not applicable to paper type.

    Table 2: Resources

    No key resources detected.


    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…