Overview
The ProMab SARS-CoV-2 IgG ELISA kit was designed, developed, and produced for the qualitative detection of IgG antibodies specific for the SARS-COV-2 nucleocapsid (N) protein. For detailed information, please check our User Guide.
A few highlights of ProMab's SARS-CoV-2 IgG ELISA Kit:
•All made in USA
•High-throughput and automation
•High sensitivity
•Results within two hours
•Costs less than $10 per test
Background
A new coronavirus, SARS-CoV-2 causing coronavirus disease 19 (COVID-19), has recently appeared to cause a human global pandemic. Whereas molecular diagnostic tests such as qRT-PCR detecting viral RNA were rapidly developed, the serologic assays detecting antibodies in patients are urgently needed. Validated serologic assays are important for several reasons: 1. for detection of the viral reservoir and epidemiological studies, for detection of asymptomatic cases and estimation of mortality; 2. for evaluation of vaccine development; 3. for development of therapeutic antibodies. The tests that not only detect the virus but also detect immunity to SARS-CoV-2 are crucial to overcome the pandemic, to limit economic damage, get people back to work, reopen borders - and those whose immunity can be demonstrated should be able to return to work, without risk (1). The Food and Drug administration (FDA) already relaxed assessment criteria for different SARS-COV2 detection kits.
With antibody detection kits, there is versatility in analyzing the results. You can show that the person overcame COVID-19 disease and has developed antibodies (which means they are immune and can resume working), something that cannot be shown with a PCR kit. It can show that vaccines are working in clinical trials or be used in contact tracing weeks or longer after a suspected infection in an individual.
Antibody tests require knowledge of specific viral proteins which cause immune system to respond and to trigger production of antibodies, detect virus and neutralize the virus. These viral proteins are produced in the lab as recombinant proteins and are used in this ELISA kit to detect antibodies present in the patient serum. ProMab developed several ELISA kits, with this example using the Nucleocapsid protein of SARS-CoV-2 to detect antibodies from human serum.
Assay Principles
The ProMab SARS-CoV-2 IgG ELISA kit was designed, developed, and produced for the qualitative detection of IgG antibodies specific for the SARS-CoV-2 nucleocapsid (N) protein. Human serum samples are added to a 96-well microplate that has been pre-coated with SARS-CoV-2 recombinant N protein. During 30 minutes of incubation where N protein-specific IgG antibody in the serum are "trapped" and bound to the plate, the other non-specific antibodies and proteins are removed with a washing step. Next, horseradish peroxidase (HRP)-labeled goat anti-human IgG Fc is added to each well, and binds to the Fc portion of the N protein-specific IgG for 30 minutes. After another washing step to remove the unbound HRP-labeled antibody, an HRP substrate is added to the wells. Over the course of 20 minutes, the green/blue TMB substrate is converted by HRP into a yellow colored product. The reaction is stopped with sulfuric acid and the intensity of the colored product is detected using a spectrophotometric microplate reader.
Disclaimer for US Clients
At this time, ProMab's SARS-CoV-2 IgG ELISA Kit is available for research use only and recommended for BSL-2 laboratories.
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
- Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This kit is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.