SARS-CoV-2 IgG Seroconversion ELISA KitICOV2IGGKT
This SARS-CoV-2 IgG Seroconversion ELISA Kit from Innovative Research is intended for the qualitative determination of SARS-CoV-2 specific antibodies of IgG class in plasma or serum samples. Strip well format. Reagents for up to 96 tests. Bulk discounts available, please contact us for details.
In addition to research use, this kit is suitable for in vitro diagnostic (IVD) use by clinical laboratories certified to perform moderate or high complexity tests in the United States. This test is currently being evaluated by the FDA under Emergency Use Authorization (EUA) and is pending approval.
This assay has been specifically developed using the SARS-CoV-2 receptor binding domain (RBD) of the spike protein. This delivers reliable and consistent results with a high degree of reproducibility.
This assay can be performed in 70 minutes, and has an overall sensitivity of 97-100% and specificity of 100%.
Principle of the Assay:
SARS-CoV-2 specific antibodies will bind to the purified recombinant HEK cell derived receptor-binding domain (RBD) of the SARS-CoV-2 spike protein coated on the microtiter plate. After appropriate washing steps, horseradish peroxidase labeled polyclonal anti-human IgG secondary antibody binds to the captured protein. Excess secondary antibody is washed away and TMB substrate is used for color development at 450 nm. Samples that exceed a determined cut-off value are designated positive by this assay.
- Detection Target: SARS-CoV-2 specific antibodies of isotype IgG
- Dilution of Samples: A 1:51 dilution of serum samples is suggested for best results.
- Expected Values: Significant seroconversion as demonstrated by antibodies specific to both the full-length SARS-CoV-2 spike protein and the RBD region has been detected as early as two days post symptom onset.
Sensitivity: 97% for samples obtained more than 14 days after symptom onset (n=37), 100% for samples obtained more than 21 days after symptom onset (n=32).
Specificity: 100% (n=89)
Percent Agreement: Positive 100%; Negative 91%
Storage: Store all kit components at 4°C upon arrival. Return any unused microplate strips to the plate pouch with desiccant. Reconstituted controls may be stored at -80°C for later use. Store all other unused kit components at 4°C. This kit should not be used beyond the expiration date.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as KHU1, NL63, OC43, or 229E. This serological assay can be used for applications like characterizing immune responses to viral infection by determining the presence of viral antigen-specific antibodies in infected and recovered patient sera. At Innovative Research, we provide reliable, consistent products that deliver reliable, consistent results.
This material is sold for in-vitro use only for manufacturing and research. This material is not suitable for human or animal use. While we make every effort to ensure the safety of our products, we recommend handling any biological materials with standard precautions as if capable of spreading infectious disease. The statements herin are offered for informational purposes only to be used solely for your consideration, investigation, and verification.
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