Introduction

The KaiBiLi^TM  COVID-19 Neutralization Antibody Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of neutralization antibody to 2019-Novel Coronavirus in human whole blood, serum or plasma specimen. It is only used as a referential detection indicator for the effect of vaccine. It is not suitable for general population screening. The novel coronaviruses belong to the β genus.

COVID-19 is an acute respiratory infectious disease. 2019-nCOV has several structural proteins including spike (S), envelope (E), membrane (M) and nucleocapsid (N). The spike protein (S) contains a receptor binding domain (RBD), which is responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ACE2). It is found that the RBD of the 2019-nCOV S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells of the deep lung and viral replication. Infection with the 2019-nCOV initiates an immune response, which includes the production of antibodies in the blood. The secreted antibodies provide protection against future infections from viruses, because they remain in the circulatory system for months to years after infection and will bind quickly and strongly to the pathogen to block cellular infiltration and replication. These antibodies are named neutralization antibodies.

Detection

For detection of neutralization antibody to 2019-Novel Coronavirus in human whole blood, serum or plasma specimen.

Specimen

Whole blood, serum or plasma specimen.

Accuracy

Relative Sensitivity：91.82%   

Relative Specificity：99.99%  

Accuracy：97.35%

Time to results

Read results at 15 minutes and no more than 30 minutes.

Kit storage conditions

2~30°C.

Contents

※Free Safety Lancet and Alcohol pad

Ordering Information