SARS-CoV-2 Neutralizing Antibody ELISA Kit (DEIASL055)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Size
96T
Sample
Serum, plasma
Intended Use
The SARS-CoV-2 Neutralizing Antibody Test Kit can detect circulating neutralizing antibodies against SARS-CoV-2 that block the interaction between the receptor binding domain of the viral spike glycoprotein (RBD) with the ACE2 cell surface receptor. The assay detects any antibodies in serum and plasma that neutralize the RBD-ACE2 interaction. The test is both species and isotype independent.
Storage
The unopened kit is stable for at least 6 months from the date of manufacture if stored at 2°C to 8°C, and the opened kit is stable for up to 1 month from the date of opening at 2°C to 8°C.
Precision
1. Intra-assay: One known level of control was spiked into sample buffer as a test sample. The sample was tested 10 times on the same plate to evaluate intra-assay precision of the kit. Intra-assay variation of this kit is less than or equal to 10%.
2. Inter-assay: One known level of control was spiked into sample buffer as a test sample. The sample was tested on 3 plates which were randomly selected from 3 different lots to evaluate inter-assay precision of the kit. Inter-assay variation of this kit is less than or equal to 15%.
Sensitivity
Clinical Performance:
Serum samples from a cohort of patients were tested using the neutralization test kit. The combined cohort consisted of samples from normal healthy people (n=97) and samples from RT-PCR confirmed SARS-CoV-2 positive patients (n=60).

*It is important to note that not all PCR positive COVID-19 patients seroconvert.
General Description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease 2019 (COVID-19), which is contagious in humans.
SARS-CoV-2 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 SARS-CoV-2 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 SARS-CoV-2 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 neutralizing antibodies.

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