key: cord-0758095-wu5ymshb authors: Meletis, Georgios; Gkeka, Ioanna; Tychala, Areti; Fyntanidou, Barbara; Kouroudi, Lydia; Skoura, Lemonia title: Laboratory evaluation of the Abbott ID NOW rapid severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) amplification assay and its potential use in the emergency department date: 2021-08-02 journal: Infection control and hospital epidemiology DOI: 10.1017/ice.2021.360 sha: f574b343751f58a91454e79725aeb475a7fd9227 doc_id: 758095 cord_uid: wu5ymshb nan predictive value was 88.89%, and the κ coefficient of agreement was 0.805 (P < .005). The time to result of ID NOW was 5 minutes or less for positive samples and 10-15 minutes for negative samples. The rapid times to positive results of the ID NOW were achieved regardless of the Ct values obtained by NeuMoDx and Abbott RealTime assays for the respective positive samples. Previous studies have reported low sensitivity for the ID NOW test using nasopharyngeal swabs in transport media. [5] [6] [7] [8] In a recent large study by Sepulveda et al 9 in which dry swabs were used, ID NOW showed very high sensitivity for detection of patients with high levels of SARS-CoV-2 RNA but lower overall sensitivity compared with the Xpert SARS-CoV-2 assay. In our evaluation, the 2 cases of disagreement with the Abbott RealTime SARS-CoV-2 assay had high Ct values, indicating the presence of low viral loads. Considering that low-viral-load samples are commonly unable for viral growth in cell cultures, 9 the clinical impact of ID NOW should be approached with respect to the advantage of saving time in detecting infected patients and the disadvantage of false negatives with lower viral loads. Even though IATs are not yet ready to entirely replace real-time RT-PCR, the implementation of assays such as ID NOW could be beneficial in reducing turnaround times, especially in emergency departments, as well as the overall costs of SARS-CoV-2 detection. Current laboratory diagnosis of coronavirus disease 2019 COVID-19 infection diagnosis: potential impact of isothermal amplification technology to reduce community transmission of SARS-CoV-2. The carbapenemase menace: do dual mechanisms code for more resistance? Canadian Public Health Laboratory Network and the Canadian Society of Clinical Chemists. Interim guidance on the use of the Abbott ID NOW instrument and COVID-19 assay COVID-19) update: FDA informs public about possible accuracy concerns with Abbott ID NOW point-of-care test. US Food and Drug Administration website Performance of Abbott ID Now COVID-19 rapid nucleic acid amplification test using nasopharyngeal swabs transported in viral transport media and dry nasal swabs in a New York City academic institution Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients Comparison of Cepheid Xpert Xpress and Abbott ID Now to Roche cobas for the rapid detection of SARS-CoV-2 Clinical evaluation of three sample-to-answer platforms for detection of SARS-CoV-2 Performance of the Abbott ID NOW rapid SARS-CoV-2 amplification assay in relation to nasopharyngeal viral RNA loads Acknowledgments.Financial support. No financial support was provided relevant to this article. All authors report no conflicts of interest relevant to this article.