Development, Analytical, and Clinical Evaluation of Rapid Immunochromatographic Antigen Test for SARS-CoV-2 Variants Detection.

ABSTRACT: The antigen rapid diagnostic test (Ag-RDT) is a useful diagnostic tool for the detection and management of COVID-19 spread. Global SARS-CoV-2 variant outbreaks have highlighted the need for a test capable of detecting SARS-CoV-2 variants with high sensitivity and a low limit of detection. This study aimed to develop and evaluate, both analytically and clinically, an antigen rapid diagnostic test (the KestrelTM COVID-19 Ag Rapid Test) for professional use. A lateral flow immunoassay-based diagnostic test kit was developed, and various aspects of its analytical performance were evaluated. This test kit was clinically evaluated by two independent laboratories and showed closely related results of 96.49% and 98.33% of sensitivity, 100% and 100% of specificity, and 99.01% and 99.44% of accuracy

SUBMITTER: Szekely J 

PROVIDER: S-EPMC8871278 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature