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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
Research Article
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Cite this article as: eLife 2021;10:e65726 doi: 10.7554/eLife.65726

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.

Reviewing Editor

  1. Goutham Narla, University of Michigan, United States

Publication history

  1. Received: December 13, 2020
  2. Accepted: April 14, 2021
  3. Accepted Manuscript published: April 20, 2021 (version 1)
  4. Version of Record published: April 28, 2021 (version 2)

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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    SARS-CoV-2, the virus responsible for COVID-19, causes widespread damage in the lungs in the setting of an overzealous immune response whose origin remains unclear.

    Methods:

    We present a scalable, propagable, personalized, cost-effective adult stem cell-derived human lung organoid model that is complete with both proximal and distal airway epithelia. Monolayers derived from adult lung organoids (ALOs), primary airway cells, or hiPSC-derived alveolar type II (AT2) pneumocytes were infected with SARS-CoV-2 to create in vitro lung models of COVID-19.

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    Infected ALO monolayers best recapitulated the transcriptomic signatures in diverse cohorts of COVID-19 patient-derived respiratory samples. The airway (proximal) cells were critical for sustained viral infection, whereas distal alveolar differentiation (AT2→AT1) was critical for mounting the overzealous host immune response in fatal disease; ALO monolayers with well-mixed proximodistal airway components recapitulated both.

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    Findings validate a human lung model of COVID-19, which can be immediately utilized to investigate COVID-19 pathogenesis and vet new therapies and vaccines.

    Funding:

    This work was supported by the National Institutes for Health (NIH) grants 1R01DK107585-01A1, 3R01DK107585-05S1 (to SD); R01-AI141630, CA100768 and CA160911 (to PG) and R01-AI 155696 (to PG, DS and SD); R00-CA151673 and R01-GM138385 (to DS), R01- HL32225 (to PT), UCOP-R00RG2642 (to SD and PG), UCOP-R01RG3780 (to P.G. and D.S) and a pilot award from the Sanford Stem Cell Clinical Center at UC San Diego Health (P.G, S.D, D.S). GDK was supported through The American Association of Immunologists Intersect Fellowship Program for Computational Scientists and Immunologists. L.C.A's salary was supported in part by the VA San Diego Healthcare System. This manuscript includes data generated at the UC San Diego Institute of Genomic Medicine (IGC) using an Illumina NovaSeq 6000 that was purchased with funding from a National Institutes of Health SIG grant (#S10 OD026929).

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