key: cord-0691084-6jy6ul6j
authors: Harrington, Amanda; Cox, Brian; Snowdon, Jennifer; Bakst, Jonathan; Ley, Erin; Grajales, Patricia; Maggiore, Jack; Kahn, Stephen
title: Comparison of Abbott ID Now and Abbott m2000 Methods for the Detection of SARS-CoV-2 from Nasopharyngeal and Nasal Swabs from Symptomatic Patients
date: 2020-07-23
journal: J Clin Microbiol
DOI: 10.1128/jcm.00798-20
sha: 6cbda3c2c2e528962b81d7b724fb19eaa118150e
doc_id: 691084
cord_uid: 6jy6ul6j

The ID NOW COVID-19 (IDNCOV) assay performed on the ID Now Instrument (Abbott Diagnostics, Scarborough, Inc. Scarborough, ME) is a rapid diagnostic test that can be performed in a point of care setting equivalent to CLIA waived testing.….

the test (or lack of experience) did not necessarily contribute to the variability in positivity that was found in this evaluation. Compared to the ACOV cycle numbers (CN) (which are similar but not directly comparable to cycle thresholds from other reverse transcription-PCR [RT-PCR] assays due to the unique ACOV assay design), a significant proportion, but not all, discordant samples exhibited at higher cycle numbers (Fig. 1 .60), ranging from 6.79 to 30.63, with a standard deviation of 5.1. These differences are statistically different (P ϭ 6.75eϪ16). The stated limit of detection in the published instructions for use is 100 copies/ml for ACOV (2) and approximately 3,225 copies/ml when calculated based on the published genomes/reaction for IDNCOV (3) . Based on the distribution of cycle numbers seen in Fig. 1 and performance agreement among the sites, negative results on IDNCOV are likely related to both a higher limit of detection on IDNCOV and preanalytical sampling error.

Overall, the ID Now COVID-19 assay demonstrated significantly different performance characteristics compared to the Abbott RealTime SARS-CoV-2 assay. 

Illinois Department of Public Health Guidelines for Diagnosis and Testing of Persons Under Investigation for COVID-19. Illinois Department of Public Health

Abbott RealTime SARS-CoV-2 Instructions for Use. 51-608445/R2

ID NOW COVID-19 Instructions for Use. IN190000 Rev. 1 2020/03

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.