- SARS-CoV-2 spike protein Receptor Binding Domain (RBD)
- Target antigen selected to correlate with neutralizing antibody
- Measurement against pre-coated standards
- 96-well plate with 76 patient samples (singlet); 38 patient samples (duplicate)
- Quantitative antibody titers with positive-negative determination, no multiple dilutions
- For use with human serum, citrate plasma or EDTA plasma
- Manual or automated plate processing
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.
SARS-CoV-2 Structures and Neutralizing Antibodies
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 in 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).
The Need for Serology Testing
There is an urgent need to understand which portions of the population may already have developed 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.
In accordance with FDA guidance:
These kits are provided for use only by laboratories certified under CLIA to perform high complexity testing, they are not to be used for at-home testing. The kits are sold in the United States under Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
- This test has not been reviewed by the FDA.
- 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 screening of donated blood.