SARS-CoV-2 IgG Seroconversion ELISA Kit
This kit is provided for in vitro diagnostic (IVD) use only by clinical laboratories certified to perform moderate or high complexity tests in the United States. It is also available labeled for research use only (RUO) upon request. This test has not been reviewed by the FDA. The assay is currently being considered for Emergency Use Authorization. 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 coronavirus HKU1, NL63, OC43, or 229E. Not for the screening of donated blood.
- Sensitivity: 97% (>14 days post symptom onset, n=37), 100% (>21 days, n=32)
- Specificity: 100% (n=89)
- Positive Percent Agreement: 100
- Negative Percent Agreement: 91
- Assay Time: 70 minutes
- Number of Tests: 96 per kit
SARS-CoV-2 is the novel coronavirus that causes CoronaVirus Disease 2019 (COVID-19). Serological assays are critical for characterizing immune responses to viral infections by determining the presence of viral antigen specific antibodies in infected and recovered patient sera. The sensitive and specific qualitative detection of SARS-CoV-2 specific antibodies of isotype IgG in human serum is easily performed with this 96 well strip format ELISA kit. A 1:51 dilution for serum samples is suggested for best results.
SARS-CoV-2 specific antibodies in patient samples 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 secondary polyclonal anti-human IgG antibody binds to the captured protein. Excess secondary antibody is washed away and TMB substrate is used for color development at 450nm. Samples that exceed a determined cutoff value are designated positive by this assay.
Produced under license from the Icahn School of Medicine at Mount Sinai, New York, NY, USA.
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