COVID-19 Nucleocapsid IgG Quantitative ELISA Assay Kit
COVID-19 Nucleocapsid IgG Quantitative ELISA Assay Kit was developed and manufactured in the US
Size: 1×96 wells
Sensitivity: 0.17 U/mL
Dynamic Range: 0.17-200 U/mL
Incubation Time: 1.5 Hours
Sample Type: Serum
Species Sample: Human
Sample Size: 10 µL
Alternative Names: Serology, Coronavirus, COVID-19, Corona, Serological
Panels were studied with a minimum of eight confirmed disease state samples with this serology assay. No interference was observed for the following disease or infectious agents:
- Anti-influenza A
- Anti-influenza B
- Hepatitis C (HCV)
- Antinuclear Antibodies (ANA)
- Respiratory Syncytial (RSV)
The COVID-19 Nucleocapsid IgG Quantitative ELISA Assay kit is designed, developed, and produced for the quantitative measurement of the human anti-COVID-19 IgG antibody in 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 nucleocapsid protein. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled polyclonal goat anti-human 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.
Information for US Customers
During this crisis, steps are being taken to ensure that we can provide access to quality products for diagnostic testing. The Food and Drug Administration (FDA) has issued guidance which allows for distribution of the serological tests. At this time, the kits are released for sale in the United States under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
The kits are registered under product code QKO.
Per the aforementioned guidance, the following statements are required:
- 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.