Serology or antibody testing as a clinical tool may aid with determining who has developed an adaptive immune response to SARS-CoV-2 either from recent or previous infection.
Traceable to the First WHO International Standard
The availability of an International Standard (IS) for antibodies facilitates the standardization of SARS-CoV-2 serological methods and allows for comparison of datasets across laboratories. Standardization against an international reference allows for the accurate calibration of assays, reducing interlaboratory variations and creating a common language for reporting results. This will help determine the antibody response in the development of vaccines and therapeutics, and improve our understanding of virus epidemiology.
Alignment with an international standard can assist in comparison of assays detecting the same class of immunoglobulins with the same specificity (e.g. anti-receptor binding domain IgG). Manufacturers reagents are recommended to be calibrated to the IS acknowledging the different antigen targets and that they may have different potencies of neutralizing and binding antibody recognition. Results will be expressed In International Unit per milliliter (IU/mL).
Accurate and Reliable Coronavirus Antibody Results That Clinicians Can Trust
Results are specific to IgG antibodies
Quantitative and qualitative assay allows to establish Ab baseline and assessment of titer changes over time to understand durability of immune response:
- PPA: 100% (95% CI: 95.1 - 100.0%) ≥ 15 days post-symptom onset
- NPA: 99.8% (95% CI: 99.4 - 99.9%)
High Medical Value with Targeted Antibody Identification
To identify an immune response against the SARS-CoV-2 coronavirus, it is important to target the right antibodies.
- The Access SARS-CoV-2 IgG (1st IS) assay is designed to target antibodies against the coronavirus spike protein that may be more likely to confer an immune response.
- Laboratory studies show that to identify an immune response against the SARS-CoV-2 coronavirus, it is important to target the right antibodies
- The Access SARS-CoV-2 IgG (1st IS) assay detects antibodies to the RBD (Receptor Binding Domain) of the spike protein
Novel Coronavirus Structure
Figure 1. A coronavirus contains four structural proteins, including spike (S), envelope (E), membrane (M) and nucleocapsid (N) proteins.
Seamless Integration with Routine Lab Workflow
The Access SARS-CoV-2 IgG (1st IS) assay can be run in random access mode, seamlessly integrating into current laboratory workflow without the need for batching or special maintenance. This can help your laboratory experience industry-leading system uptime.
How else can the Access SARS-CoV-2 IgG (1st IS) assay empower your laboratory to fight the coronavirus pandemic?
- Access SARS-CoV-2 antibody test throughput on Beckman Coulter immunoassay and integrated systems leads the industry at up to 200 tests per hour depending on the analyzer used (up to 4,800 tests/day)
- QC procedures only need to be run once every 24 hours, or as required by individual laboratory procedure, and the assay comes in 200 tests/kit, requiring less frequent ordering
- REMISOL Advance middleware provides patient results from both diagnostic and serology tests on one screen to help improve laboratory efficiency