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The ID NOW COVID-19, a high-speed high-performance assay.

Eric Farfour1, M Asso-Bonnet2, M Vasse2

  • 1Service de biologie clinique, Hôpital Foch, Suresnes, France. e.farfour@hopital-foch.com.

European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology
|April 15, 2021
PubMed
Summary

The ID NOW COVID-19 assay offers rapid and accurate COVID-19 identification, showing 94.9% positive agreement with RT-PCR. This molecular test is a reliable tool for detecting SARS-CoV-2.

Keywords:
COVID-19Isothermal amplificationLAMPNEARRT-PCRSARS-CoV-2

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Area of Science:

  • Clinical diagnostics
  • Molecular biology
  • Infectious disease research

Background:

  • The ID NOW COVID-19 assay is a rapid diagnostic tool for identifying SARS-CoV-2 infections.
  • Concerns regarding the performance of the ID NOW COVID-19 assay necessitate thorough evaluation.
  • Accurate and timely diagnosis is crucial for managing the COVID-19 pandemic.

Purpose of the Study:

  • To evaluate the diagnostic performance of the ID NOW COVID-19 assay.
  • To compare the ID NOW COVID-19 assay against a reference RT-PCR method.
  • To assess the reliability of the ID NOW COVID-19 assay for clinical use.

Main Methods:

  • Evaluation of 48 fresh nasopharyngeal swabs using the ID NOW COVID-19 assay.
  • Comparison of ID NOW results with a reference reverse transcription-polymerase chain reaction (RT-PCR) assay.
  • Calculation of positive percent agreement, negative percent agreement, and Kappa value.

Main Results:

  • The ID NOW COVID-19 assay demonstrated a positive percent agreement of 94.9% and a negative percent agreement of 100% compared to RT-PCR.
  • Only two false negatives were identified, with high PCR cycle threshold values (37.5 and 39.2).
  • A Kappa value of 0.88 indicated substantial agreement between the two methods.

Conclusions:

  • The ID NOW COVID-19 assay is a highly accurate and rapid diagnostic tool for SARS-CoV-2 detection.
  • The assay's performance, especially when using universal transport media (UTM), supports its clinical utility.
  • The ID NOW COVID-19 assay allows for repeat testing and further genomic analyses from the same sample, enhancing its value.