AntiCoV-ID IgG Quantitative ELISA Assay Kit

$695.00

The AntiCoV-ID IgG ELISA Assay Kit is a method for the quantitative and qualitative determination of anti-SARS-CoV-2 spike protein receptor binding domain (RBD) IgG antibodies in human serum, citrate plasma or EDTA plasma. s. This test is not the same as PCR or Rapid Test. The Coronavirus COVID-19 IgM ELISA Assay Kit is IVD, CE-Marked.

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
IVD, CE-Marked

Controls Included


Cross Reactivity

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

Assay Principle

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.


Products Related to Coronavirus COVID-19 IgM ELISA Assay

Coronavirus COVID-19 IgG ELISA Assay Kit
Coronavirus COVID-19 IgM ELISA Assay Kit
Anti-SARS-CoV-2 S1 (RBD) IgG ELISA Assay
Anti-SARS-CoV-2 (S1, S2, N) IgG ELISA Assay Kit

Technical Information


Additional Information

Assay Background

The SARS-CoV-2 virus is a highly contagious pathogen, and it has been implicated in a worldwide pandemic. The SARS-CoV-2 virus is responsible for the disease it causes, namely the Coronavirus Disease 2019 (COVID-19), and 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, the host may exhibit mild symptoms or may be asymptomatic. However, more severe cases are associated with severe respiratory distress, pneumonia, and even death.

SARS-CoV-2 is of the genus Betacoronavirus. Coronavirus 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 and entry of the virus into cells. Entry is thought to be accomplished by binding to 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 portion of the population may already have developed endogenous IgG-type antibodies against the virus, to support convalescent plasma clinical trials by identifying those with IgG-type antibodies, and to 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 this data in a quantitative and high-throughput fashion in order understand differences in the antibody titers between patients.


 

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