2019-nCoV Neutralizing Antibody Detection Kit (Fluorescence Immunochromatography)

Primary DI

06974521003182

Basic UDI-DI Code

B-06974521003182

Reference

SUPF054025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

2019-nCoV Neutralizing Antibody Detection Kit is a rapid, serological test to qualitatively detect the novel coronavirus (2019-nCoV) neutralizing antibodies in human serum, plasma, whole blood and fingertip blood samples and is urgently needed to determine not only predicted humoral protection, but also vaccine efficacy during clinical trials and after large-scale vaccination. Coronavirus disease 2019 (COVID-19), caused by the novel human coronavirus 2019-nCoV, is currently a major threat to public health worldwide. The genome of coronavirus encodes four structural proteins, namely Nucleoprotein, small membrane protein, membrane protein and Spike protein (S protein). The virus receptor-binding domain (RBD) is an important domain in Spike protein and is the main structural domains for inducing neutralizing antibodies and T-cell immune responses. The viral spike protein binds the host receptor angiotensin-converting enzyme 2 (ACE2) via the receptor-binding domain (RBD) , and thus is believed to be a major target to block viral entry. neutralizing antibodies that had receptor binding motif of RBD compete strongly with human ACE2. Plaque reduction neutralization (PRN) assay is gold standard method to detect neutralizing antibodies to 2019-nCoV, but it need a biosafety level 3 laboratory and more than 3 day to finish the test. Enzyme-linked immunosorbent assay (ELISA) and lateral flow assay (LFA) rapid tests are also effective test methods. The test based on fluorescence immunochromatographic assay analysis technics, which can give a result within 15 minutes. The kit is a preliminary screening reagent. Any result needs to be confirmed by clinical symptoms, epidemiology, and gold standard reagents. For professional use only.

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