SARS-CoV-2 ELISA Assay for the Detection of Neutralizing Antibodies
The COVID-19 pandemic is one of the greatest infectious disease challenges the world has faced in recent history. Presently, few treatment options exist, therefore, the need to evaluate antibodies to fight the SARS-CoV-2 virus is at an all-time high.
Leinco Technologie’s has developed ImmunoRank™, a SARS-CoV-2 high throughput neutralization test and Trace™, a IgG serology assay using the SARS-CoV-2 receptor-binding domain (RBD) protein as the capture antigen. Both these ELISA assays are highly sensitive and specific to recent coronavirus exposure. At this time, it is unknown for how long antibodies persist following infection and if the presence of neutralizing antibodies confers protective immunity.
COVID-19 ImmunoRank™ Neutralization MICRO-ELISA Assay
The COVID-19 ImmunoRank™ Neutralization MICRO-ELISA, is a test for qualitative detection of circulating SARS-CoV-2 neutralizing antibodies. The assay is designed to detect antibodies of all Ig classes in human plasma or serum that bind to the SARS-CoV-2 Receptor Binding Domain (RBD) and are capable of blocking the binding of the RBD to angiotensin-converting enzyme 2 (ACE2), the viral entry receptor on the surface of target cells. This assay identifies individuals with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection. Patent Pending.
Order ImmunoRank™ View Product Insert Technical Protocol Video White Paper
| Product Number | S2000 |
| Number of Tests | 90 Tests |
| Assay Range | 0-100% Neutralization |
| Assay Length | 80 Minute Assay Procedure |
| Specificity | 99.8% |
| Antigen | SARS-CoV-2 RBD |
| Detects | Neutralizing Antibodies Of All Ig Classes (Total Antibody) |
For additional assay data sets and protocols, go to full product data sheet and insert.
Comparing ImmunoRank to PRNT50 Titers. 117 total specimens were collected retrospectively consisting of a study specific cohort of 75 negative plasma samples from apparently healthy donors collected prior to 12/01/2019, 32 positive specimens collected from subjects who tested positive for SARS-CoV-2 by an EUA approved PCR test, and 10 specimens containing potentially cross-reactive antibodies to HIV.
Example of the dose dependent binding curve of SARS-CoV-2 RBD-HRP to immobilized ACE2.
COVID-19 Trace™ IgG MICRO-ELISA Assay
The COVID-19 Trace™ IgG MICRO-ELISA is a serology test intended for the qualitative detection of human Anti-SARS-CoV-2 IgG antibodies to the RBD protein antigen of SARS-CoV-2 in human serum or plasma. The test is a solid phase enzyme-linked immunosorbent assay (ELISA), using a chromogenic enzyme substrate and the recombinant SARS-CoV-2 RBD as the capture antigen. This assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Trace™ has completed the Section IV.D notification process under FDA “Policy for Coronavirus Disease – 2019 Test During the Public Health Emergency (revised)” and has not been reviewed by the FDA.
| Product Number | S1500 |
| Number of Tests | 90 Tests |
| Assay Length | 80 Minute Assay Procedure |
| Specificity | 99.4% |
| Antigen | SARS-CoV-2 RBD |
| Specificity | IgG |
For additional assay data sets and protocols, go to full product data sheet and insert.
A dose dependent binding curve showing reactivity of a neutralizing monoclonal antibody with immobilized RBD.
Dose dependent binding curves from a panel of recombinant human monoclonal antibodies sequenced from plasma B-cells of COVID-19 survivors using the COVID-19 Trace IgG MICRO-ELISA Serology Assay. Clones A, B, C and D recognize the r-SARS-CoV-2 receptor binding domain (RBD) and clone E is specific for the SARS-CoV-2 r-N-terminal domain (NTD) of the spike protein. When these antibody binding curves are compared with their neutralization potential using the ImmunoRank Neutralization assay, the results indicate that neutralization potential is not a direct correlation to RBD binding titer and the ImmunoRank Neutralization assay is required to determine the neutralizing potential of antibodies present in plasma or serum.