AntiCoV-ID IgG Quantitative ELISA Assay Kit
AntiCoV-ID IgG Quantitative ELISA Assay Kit was developed and manufactured in the US by Akston Biosciences
Size: 1×96 wells
Dynamic Range: 3.28-2000 ng/mL
Incubation Time: 2.5 Hours
Sample Type: Serum and Plasma
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-Mumps IgG Antibodies
- Anti-Measles IgG Antibodies
- Anti-EBV/Anti-Epstein-Barr Nuclear Antigen IgG Antibodies
- Anti-CMV IgG Antibodies
- Anti-VZV IgG Antibodies
- Anti-Influenza IgG Antibodies
Akston Biosciences’ AntiCoV-ID™ Quantitative IgG ELISA is an indirect, enzyme linked immunosorbent assay (ELISA) designed to measure anti-spike protein receptor binding domain (RBD) IgG antibodies against the SARS-CoV-2 virus (COVID-19 virus, 2019 Novel Coronavirus) in human patient serum and plasma samples, including heat-inactivated serum or heat-inactivated plasma. The indirect immunoassay uses a recombinant SARS-CoV-2 spike protein RBD immobilized on ELISA plates as the capture antigen to bind the SARS-CoV-2 specific anti-spike RBD antibodies in the serum samples when incubated in the microplate wells. A simple wash step removes all unbound proteins, leaving the anti-SARS-CoV-2 spike protein RBD antibodies bound to the plate. A second incubation is performed where the anti-spike protein RBD antibodies are detected by an anti-human IgG antibody (not cross-reactive to IgM) conjugated to horseradish peroxidase (HRP). After a second simple wash step to remove the unbound enzyme-conjugate, the assay plate wells are incubated with 3,3’,5,5’-trimethylbenzidine which causes a colorimetric change that is proportional to the amount of bound enzyme conjugate in each well. The color development is stopped by adding acid that halts development, and the color density of each well is measured using a spectrophotometric microplate reader.
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, the submission number is EUA201110
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.