AntiCoV-ID™ IgG ELISA
Quantitative determination of IgG against the novel coronavirus (SARS-CoV-2) in human serum, plasma, or heat-inactivated human serum or plasma.
The SARS-CoV-2 virus is responsible for the Coronavirus Disease 2019 (COVID-19) and the ensuing worldwide pandemic. As such the virus is also known as the COVID-19 virus or the 2019 Novel Coronavirus. COVID-19 is associated with symptoms such as fever, tiredness, dry cough, aches and pains, nasal congestion, runny nose, and sore throat. In some cases, an infected patient may exhibit mild symptoms or may be asymptomatic. However, more severe cases are associated with severe respiratory distress, pneumonia, and even death.
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SARS-CoV-2 is of the genus Betacoronavirus and contains four protein structures, including the spike (S), envelope (E), membrane (M), and nucleocapsid (N) proteins. Among them, S protein is principally involved in the attachment of the virus and entry into cells. Entry is thought to be accomplished by binding to the human ACE2 receptor via the S protein receptor-binding domain (RBD). Therefore, due to its critical role on cell entry, the SARS-CoV-2 spike protein RBD has emerged as a strong target for the development of virus attachment inhibitors, neutralizing antibodies, and vaccines (Jun Lan, et al. Nature 2020).
There is an urgent need to understand which proportions of the population may already have developed strong immunity to SARS-CoV-2 via seroconversion to produce endogenous IgG-type antibodies against the virus. In addition such information will support convalescent plasma clinical trials by identifying those with IgG-type antibodies and can help identify which therapies perform well in vaccination trials against SARS-CoV-2. Moreover, due to the vast scale of the pandemic, there is an urgent need to obtain these data in a quantitative and high-throughput fashion in order understand differences in the antibody titers between patients.
Information for US Customers
On May 26, 2020 the U.S. Food and Drug Administration (FDA) provided Emergency Use Authorization (EUA) for Akston Bioscience’s AntiCoV-ID™ IgG ELISA under EUA201110.
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088.
Frequently Asked Questions
Information for private persons:
Akston Biosciences develops and produces test systems for doctors and laboratories that cannot be performed by private individuals.
AntiCoV-ID™ IgG ELISA is an indirect, enzyme linked immunosorbent assay (ELISA) designed to measure anti-spike protein RBD 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 stuck 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) that is 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.
Overview of Test Procedure