A Final Laboratory Validation Study and Comparative Performance Evaluation of the Abbott ID NOWTM COVID-19 Assay in A Coastal California Tertiary Care Medical Center: OAJBS Publishers

A Final Laboratory Validation Study and Comparative Performance Evaluation of the Abbott ID NOWTM COVID-19 Assay in A Coastal California Tertiary Care Medical Center by Nada Aljehani* in Open Access Journal of Biomedical Science (OAJBS)

The Abbott ID NOWTM COVID-19 assay is a rapid molecular diagnostic test particularly designed for on-site, rapid turnaround point of care (POC) testing. The utilization of rapid diagnostic tests is integral to optimizing workflow within the hospital and/or procedural-based clinics. The capability to provide both rapid disposition and correct patient classification during this COVID-19 pandemic is critically important with broad infection control implications for both patients and healthcare staff. A tightly controlled, extended laboratory validation was performed at our medical center to determine the negative test agreement of the Abbott ID NOWTM compared with the BD MAXTM analyzer and/or Hologic PantherTM, laboratory-based, two target, molecular analyzers with a sensitive level of detection (LoD). This article is a follow-on evaluation from a preliminary smaller data-set study in which 117 patient’s results were included. The current data set includes a sample size of 1304 patients (over a 10-fold increase) allowing for a more robust statistical power analysis. There was strict adoption of the procedures listed in the Abbott ID NOWTM Instruction for Use (IFU) [1] insert delineating preferred practices for “optimal test performance” that also incorporates the revised Emergency Use Authorization (EUA) amendment of 17 September 2020 allowing for the use of dry nasopharyngeal (NP) swabs. Our institutional experience demonstrates an overall negative agreement of 1163 of 1178 (98.7%). Of interest, however, 11 of the original discordant results in the April to August time frame were able to be retested and 55% of the original ID NOWTM false negatives with nasal swabs that were retested with NP swabs proved to be positive, and 45% that remained false negatives (FN) even with NP swabs had Ct values > 35. As such, one could hypothesize that if dry NP swabs had been implemented months ago, that the negative test agreement could be as high as 99.4%, which equates to a 99.1% concordance similar to a previously reported correlation study [2]. It also demonstrates a LoD cutoff inflection point where sensitivity diminishes appears to be a Ct value around 35.
https://biomedscis.com/fulltext/a-final-laboratory-validation-study-and-comparative-performance-evaluation-of-the-abbott-id-nowtm-covid-19.ID.000250.php

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