KT-1035

Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit

Description


The EDI™ quantitative SARS-CoV-2 spike protein IgG ELISA Kit is an Enzyme-Linked Immunosorbent Assay (ELISA) kit for the quantitative measurement of novel COVID-19 human IgG antibody to SARS-CoV-2 in human serum. The assay may show false higher human IgG antibody concentration due to cross-reactivity from pre-existing antibodies or other possible causes. This assay is validated manually, but can be adapted to an automated instrument.

​​​​​​​This kit is for in vitro diagnostics use only.


Background


This ELISA kit is designed, developed, and produced for the quantitative measurement of novel COVID-19 human IgG antibody to SARS-CoV-2 in human serum. This assay utilizes the microplate based enzyme immunoassay technique.

​​​​​​​Assay calibrators, controls, and 1:100 diluted human serum samples are added to the microtiter wells of a microplate that was coated with COVID-19 recombinant full length spike protein. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled polyclonal goat antihuman IgG tracer antibody is added to each well. After an incubation period, an immunocomplex of "COVID-19 recombinant antigen – human anti-COVID-19 IgG antibody - HRP labeled anti-human IgG tracer antibody" is formed if there is specific coronavirus IgG antibody present in the tested specimen. The unbound tracer antibody is removed by the subsequent washing step. HRP-labeled anti-hIgG tracer antibody bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the anti-COVID-19 IgG on the wall of the microtiter well is proportional to the amount of the anti-COVID-19 IgG antibody level in the tested specimen.

Technical Specifications

For in-vitro diagnostic use.