Development and Clinical Performance of InteliSwab^® COVID-19 Rapid Test: Evaluation of Antigen Test for the Diagnosis of SARS-CoV-2 and Analytical Sensitivity to Detect Variants of Concern Including Omicron and Subvariants.

ABSTRACT:

Background and objectives

Timely detection of SARS-CoV-2 infection with subsequent contact tracing and rapid isolation are considered critical to containing the pandemic, which continues with the emergence of new variants. Hence, there is an ongoing need for reliable point-of-care antigen rapid diagnostic tests (Ag-RDT). This report describes the development, evaluation, and analytical sensitivity of the diagnostic performance of the InteliSwab^® COVID-19 Rapid Test. Methods: Samples from 165 symptomatic subjects were tested with InteliSwab^® and the results were compared to RT-PCR to determine the antigen test performance. The analytical sensitivity of InteliSwab^® for the detection of different variants was assessed by limit of detection (LOD)

SUBMITTER: Fischl MJ 

PROVIDER: S-EPMC10821026 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature