Foundation and Clinical Evaluation of a New Method for Detecting SARS-CoV-2 Antigen by Fluorescent Microsphere Immunochromatography.

ABSTRACT:

Purpose

To develop a rapid detection reagent for SARS-CoV-2 antigen for the auxiliary diagnosis of new coronary pneumonia (COVID-19), and perform the methodological evaluation and clinical evaluation of the reagent.

Method

SARS-CoV-2 N-protein test strip was created by combining fluorescent microsphere labeling technology and immunochromatographic technology, based on the principle of double antibody sandwich. Then we evaluated the analytical capability and clinical application of the strips.

Result

The limit of detection of the strips for recombinant N protein was 100 ng/ml and for activated SARS -CoV-2 virus was 1 × 10³ TCID₅₀/ml. The strips also have high analytical specificity and anti-interference capability. According to the predetermined c

SUBMITTER: Zhang C 

PROVIDER: S-EPMC7734310 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature