Diagnostic performance of the Elecsys SARS-CoV-2 antigen assay in the clinical routine of a tertiary care hospital: Preliminary results from a single-center evaluation.

ABSTRACT:

Background

This report describes a manufacturer-independent evaluation of the diagnostic accuracy of the Elecsys SARS-CoV-2 antigen assay from Roche Diagnostics in a tertiary care setting.

Methods

In this single-center study, we used nasopharyngeal swabs from 403 cases from the emergency department and intensive care unit of our hospital. The reference standard for detecting SARS-CoV-2 was the reverse-transcription polymerase chain reaction (RT-PCR) assay. Cycle threshold (Ct) values were recorded for positive RT-PCR assays. The index test was the Elecsys SARS-CoV-2 antigen assay. This electrochemiluminescence immunoassay produces results as cutoff index (COI) values, with values ≥1.00 being reported as positive.

Results

Of the 403 cases, 47 showed positive results in

SUBMITTER: Mueller T 

PROVIDER: S-EPMC8373346 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature