Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance.

ABSTRACT:

Background

High-throughput assays for the SARS-CoV-2 virus are critical to increasing test capacity and slowing the spread of COVID-19. Abbott Molecular developed and received emergency use authorization (EUA) to deploy the new RealTime SARS-CoV-2 assay, run on the automated m2000sp/rt system.

Objective

To evaluate analytical and clinical performance of the RealTime SARS-CoV-2 assay compared to the SARS-CoV-2 CDC-based laboratory developed test (LDT) in clinical use by the University of Washington Clinical Virology Laboratory (UW Virology).

Methods

RealTime SARS-CoV-2 assay limit of detection (LOD) was evaluated by testing two dilution panels of 60 replicates each. Cross-reactivity was evaluated by testing 24 clinical samples positive for various non‒SARS-CoV-2 respir

SUBMITTER: Degli-Angeli E 

PROVIDER: S-EPMC7395853 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature