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

  1. Yuan-Po Tu
  2. Jameel Iqbal  Is a corresponding author
  3. Timothy O'Leary
  1. Everett Clinic, United States
  2. James J Peters Veterans Affairs Medical Center, United States
  3. Maryland School of Medicine, United States

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 presenting for testing. The study enrolled 785 symptomatic patients, 21 of whom 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% CI 55- 96%) and had the highest correlation to RT-PCR at viral loads most likely to be associated with transmissible infections.

Data availability

All data used for analysis has been included in the figures, tables and two appendices.

Article and author information

Author details

  1. Yuan-Po Tu

    Medicine, Everett Clinic, Lake Stevens, United States
    Competing interests
    No competing interests declared.
  2. Jameel Iqbal

    Pathology, James J Peters Veterans Affairs Medical Center, Bronx, United States
    For correspondence
    Jameel.iqbal@va.gov
    Competing interests
    Jameel Iqbal, Reviewing editor, eLife.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-4598-5064
  3. Timothy O'Leary

    Pathology, Maryland School of Medicine, Baltimore, United States
    Competing interests
    No competing interests declared.
    ORCID icon "This ORCID iD identifies the author of this article:" 0000-0002-2435-9136

Funding

NIH Clinical Center (U19 AG60917)

  • Jameel Iqbal

NIH Clinical Center (R01 DK113627)

  • Jameel Iqbal

The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication.

Ethics

Human subjects: The human ethics review and IRB for these studies was approved by the United Health Group Office of Human Research Affairs (OHRA), Federal wide Assurance #: FWA00028881, OHRP Registration #: IORG0010356.

Copyright

This is an open-access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.

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  1. Yuan-Po Tu
  2. Jameel Iqbal
  3. Timothy O'Leary
(2021)
Sensitivity of ID NOW and RT-PCR for detection of SARS-CoV-2 in an ambulatory population
eLife 10:e65726.
https://doi.org/10.7554/eLife.65726

Share this article

https://doi.org/10.7554/eLife.65726

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