SARS-CoV-2 Neutralizing Antibody TEST
    Publish time 1970-01-01 08:00    
DIAGNOSTIC KIT FOR SARS-CoV-2
【PRODUCT NAME】
Diagnostic Kit for SARS-CoV-2 Neutralizing Antibody Test(CLIA)
【PACKAGE SIZE】
100 Tests/Kit，200 Tests/Kit
【INTRODUCTION】
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an enveloped non-segmented
positive-sense RNA virus. SARS-CoV-2 first discovered with a viral pneumonia case in 2019, is a new strain of
coronavirus that had never been found in humans before. The coronaviruses already known can cause cold or Middle
East Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS) and other diseases of varying
degrees. The WHO temporarily named the new virus as "2019-nCoV" on January 12, and officially named the pneumonia
infected by the virus "COVID-19" on February 11.
SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M) and nucleocapsid (N). The
spike protein (S) is the most important surface membrane protein, which contains two subunits, S1 and S2. The S1
subunit of the S protein has a receptor binding domain (RBD) and is responsible for recognizing the cell surface receptor,
angiotensin converting enzyme-2 (ACE2), while the S2 subunit takes part in membrane fusion.
Infection with the SARS-CoV-2 or after 2019-nCoV vaccination initiates an immune response, which includes the
production of neutralizing 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.
The spike protein (S) and particularly the RBD are neutralizing antibodies the most common target of vaccine designs.
The roles of spike protein (S protein) in receptor binding and membrane fusion indicate that vaccines based on the spike
protein could induce antibodies to block virus binding and fusion or neutralize virus infection. Spike protein has therefore
been selected as an important target for coronavirus vaccine and anti-viral development.
The level of neutralizing antibodies can be used to analyze a patient’s immunity against future SARS-CoV-2 infection.
【INTENDED USE】
The SARA-CoV-2 Neutralizing Antibody Kit is a chemiluminescence immunoassay(CLIA) intended for qualitative
detection of neutralizing antibodies in human serum and plasma from people vaccinated with COVID-19 vaccine. The
SARA-CoV-2 Neutralizing Antibody Kit is intended as an aid in the determination of the neutralizing antibodies against
SARS-CoV-2 that block the interaction between the receptor binding domain (RBD) of the viral spike glycoprotein with the KHB®DIAGNOSTIC KIT FOR SARS-CoV-2 Neutralizing Antibody Test (CLIA) EN
The kit must be used by medical professionals or trained operators who are proficient in performing chemiluminescence
immunoassay tests in strict compliance with the instructions given in this document.
【PRINCIPLES OF PROCEDURE】
The SARS-CoV-2 Neutralizing Antibody Kit detect neutralizing antibodies based on a competitive immunoassay, which
mimics the virus neutralization process. The kit contains two key components: the recombinant SARS-CoV-2 RBD
fragment coated microparticles(S1-RBD-MP) and the human ACE2 receptor protein (hACE2) labled alkaline
phosphatase (ACE2-AP). The protein-protein interaction between AP-RBD and hACE2 can be blocked by neutralizing
antibodies against SARS-CoV-2 RBD.
First, the samples are incubated with S1-RBD-MP to allow the binding of the neutralization antibodies to AP-RBD-MP.
The neutralization antibodies will be captured by S1-RBD-MP to form a complex, and the non-neutralizing antibody will
be removed during washing. After washing step, ACE2-AP is added and incubated with the complex.
The mixture is then added to the capture plate which is pre-coated with the hACE2 protein. The unbound AP-RBD as well
as any AP-RBD bound to non-neutralizing antibody will be captured on the plate, while the circulating neutralization
antibodies AP-RBD complexes remain in the supernatant and get removed during washing.
After washing steps, AMPPD solution is added.The substrate reacts with alkaline phosphatase to produce a light signal.
The RLU of the sample is inversely dependent on the titer of the anti-SARS-CoV-2 neutralizing antibodies.
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