Performance of an automated chemiluminescent immunoassay for SARS-COV-2 IgM and head-to-head comparison of Abbott and Roche COVID-19 antibody assays.

ABSTRACT:

Introduction

We evaluated the performance of the new Abbott SARS-CoV-2 IgM assay on the Architect immunoassay analyser and compared it to the Architect IgG/Roche Cobas total antibody assays in both SARS-CoV-2 RT-PCR positive cases and healthy controls.

Method

200 healthy control samples and 48 individuals with other antibody-positive disorders (18 hepatitis/18 dengue/11 ANA/1 dsDNA) served to assess for potential cross-reactivity. Anonymised residual leftover sera positive for SARS-CoV-2 on RT-PCR were recruited as cases (N ​= ​133). The sensitivity/specificity/cross-reactivity of the Architect IgM assay were assessed. Concordance between the 3 assays were also analysed.

Results

There was no cross-reactivity with controls and other antibody positive samples. The Archi

SUBMITTER: Cs L 

PROVIDER: S-EPMC8079267 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature