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

Abstract

The ID NOW COVID-19 assay is a promising tool for the rapid identification of COVID-19 patients. However, its performances were questioned. We evaluate the ID NOW COVID-19 in comparison to a reference RT-PCR using a collection of 48 fresh nasopharyngeal swabs sampled on universal transport media (UTM). Only 2 false negatives of the ID NOW COVID-19 were identified. They display PCR cycle threshold values of 37.5 and 39.2. The positive percent agreement and the negative percent agreement were 94.9% and 100%, respectively. The Kappa value was 0.88. The ID NOW COVID-19 combines high-speed and accurate processing. Using UTM, the ID NOW COVID-19 could be repeated in the case of invalid result. Further analyses, such as screening of genetic variants or genome sequencing, could also be performed with the same sample. As for all tests, the results should be interpreted according to clinical and epidemiological context.

Molecular characterization of SARS-CoV-2 nucleocapsid protein

“…Given the low mutation rate observed in the N protein during SARS-CoV-2 mutations, nucleic acid detection of SARS-CoV-2 can directly target the N gene. Nucleic acid detection kits specifically designed for the N gene are also currently in development (Farfour et al, 2021). In response to the ongoing et al, 2022) evolution of SARS-CoV-2 variants, Vega-Magana et al devised three specific primers and probes targeting mutation 69-70Del and K417N within the N gene.…”

Clinical evaluation of the Cue's COVID‑19 diagnostic test to detect SARS‐CoV‐2 in the upper respiratory tract

“…This phenomenon was also observed in other rapid NAAT POCTs such as the ID NOW COVID‐19 test which has the lower performance for specimens displaying the Ct value higher than 30.0. 12 Given the persistence of the SARS‐CoV‐2 testing backlog, low availability of testing supply, and shortage of licensed personnel in clinical laboratories, we need to migrate more testing capacity to the outpatient setting and the Cue's COVID‐19 test is a good option.…”

Implementation of the Abbott ID Now COVID-19 assay at a tertiary care center: a prospective pragmatic implementation study during the third wave of SARS-CoV-2 in Ontario

“…The ID Now is intended as a POC diagnostic device, and the ID Now COVID-19 assay allows for rapid isothermal molecular detection of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) gene in symptomatic patients within 7 days of symptoms onset ( Abbott 2021 ). Previously published evaluations have reported positive percent agreement (PPA) ranging from 48 to 94.9% when compared to laboratory-based RT-PCR testing ( Procop et al, 2021 , Zhen et al, 2020 , Jin et al, 2020 , Lephart et al, 2021 , Harrington et al, 2020 , Serei et al, 2021 , Rhoads et al, 2020 , Smithgall et al, 2020 , Moore et al, 2020 , Lee and Song, 2021 , Mitchell and George, 2020 , Thwe and Ren, 2020 , Basu et al, 2020 , Tu et al, 2021 , Farfour et al, 2021 , Tworek et al, 2021 ). Discrepancies in published performance are likely a result of differences in sample types (anterior nasal or nasopharyngeal swabs), and most studies pre-date the FDA advisory warning on the reduced performance of the assay when swabs are transported in universal or viral transport media ( Office of the Commissioner 2020 ).…”