Bio-Rad COVID-19 Immunoassay Testing
COVID-19 Serology Testing
Antibody testing is a critical component in overcoming the challenges posed by the SARS-CoV-2 virus. Reliable antibody detection and differentiation plays an important role in both the management of COVID-19 patients and improving our immunological understanding of this disease. Blood-based immunoassays designed to detect antibodies to SARS-CoV-2 are critical in determining the full scope of COVID-19 in the population and combating the pandemic.
Bio-Rad offers serology solutions for clinical laboratories seeking to detect total anti-nucleocapsid antibodies IgM, IgA, and IgG on an automated or manual immunoassay testing system (Platelia SARS-CoV-2 Total Ab) or use VIROTROL and VIROCLEAR SARS-CoV-2 antibody controls to ensure an unbiased independent assessment of your serology testing systems.
COVID-19 Immunoassay Testing
Platelia SARS-CoV-2 Total Ab Assay
Diagnosis of SARS-CoV-2 Infections
This assay will help to determine those who have been exposed to the SARS-CoV-2 and who have developed an immune response. In areas with low prevalence of COVID-19, a highly specific test is essential for COVID-19 surveillance and epidemiological applications.
Performance
Through clinical evaluation, the assay has demonstrated specificity of >99% and sensitivity of 92% for patients tested ≤ 8 days after symptom onset and 100% for patients tested 8 days after symptom onset. No cross-reactivity (false positive result) was observed in specimens from patients with antibodies to non-SARS coronaviruses or other medical conditions.
Authorizations
This blood-based immunoassay, designed for in vitro diagnostic testing, is the first serology assay with U.S. Emergency Use Authorization to test for all three antibodies (IgM, IgA, and IgG) in a single assay. In addition, the test has met requirements for applying the CE-mark in Europe.