Evaluation of the COVID19 ID NOW EUA assay

Stephanie L Mitchell; Kirsten St George

doi:10.1016/j.jcv.2020.104429

Evaluation of the COVID19 ID NOW EUA assay

J Clin Virol. 2020 Jul:128:104429. doi: 10.1016/j.jcv.2020.104429. Epub 2020 May 15.

Authors

Stephanie L Mitchell¹, Kirsten St George²

Affiliations

¹ Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States. Electronic address: Mitchellsl5@upmc.edu.
² Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, NY, United States.

Abstract

Background: The SARS-CoV-2 pandemic caused a major surge in needed diagnostic capacity. In response, many EUA assays have become available for clinical laboratories, and more recently, the point of care device, Abbott ID NOW.

Objectives: To determine the analytical performance of the ID NOW assay for detecting SARS-CoV-2.

Study design: Residual NP samples collected in viral transport media were tested by the ID NOW platform in two independent laboratories. Results were compared to either the CDC or New York EUA assays, which served as reference methods.

Results: Overall agreement of ID NOW was 78.7%. Sensitivity was 71.7% and specificity was 100%. Notably, all false-negative results correlated to those samples that were weakly positive.

Conclusions: ID NOW performs well for strong and moderately positive samples but has reduced sensitivity for weakly positive samples. This sensitivity, among other concerns, should be taken into consideration when using this test for patients with a low suspicion for COVID-19 disease.

Keywords: COVID-19; ID NOW; Point-of-Care; SARS-CoV-2.

Publication types

Evaluation Study

MeSH terms

Betacoronavirus / isolation & purification*
COVID-19
COVID-19 Testing
Clinical Laboratory Techniques / methods*
Coronavirus Infections / diagnosis*
False Negative Reactions
Humans
Pandemics*
Pneumonia, Viral / diagnosis*
Point-of-Care Testing*
SARS-CoV-2
Sensitivity and Specificity