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.
Some products have limited regional availability. Please contact your local sales office for any product availability questions.
SARS-CoV-2 Testing Over the Course of Viral Infection
COVID-19 Serology Testing
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Platelia SARS-CoV-2 Total Ab Assay
Platelia SARS-CoV-2 Total Ab assay is a qualitative serology test which detects total antinucleocapsid antibodies (IgM, IgA, and IgG) to SARS-CoV-2 in human serum and plasma to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
This blood-based immunoassay, designed for in vitro diagnostic testing, was granted U.S. Emergency Use Authorization in 2020 to test for total antibodies in a single assay.*
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VIROTROL SARS-CoV-2 and VIROCLEAR SARS-CoV-2 for SARS-CoV-2 Antibody Laboratory Testing
To ensure an unbiased independent assessment of a laboratory's test systems, we offer VIROTROL and VIROCLEAR SARS-CoV-2 antibody controls. These ready-to-use, liquid controls are formulated from human plasma to test on total IgG/IgM and IgG antibody assays. VIROTROL and VIROCLEAR SARS-CoV-2 are available in three separate classes specifically designed to challenge the assay cutoff of a broad range of methodologies. Laboratories can achieve greater confidence in patient test results by running independent SARS-CoV-2 quality controls with their SARS-CoV-2 antibody assays.
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 the 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 a range of COVID-19 serology testing solutions for the detection of antibodies in the period following SARS-CoV-2 infection. In addition, we offer SARS-CoV-2 positive and negative serology controls to be used across all SARS-CoV-2 antibody assays and methodologies.
Some products have limited regional availability. Please contact your local sales office for any product availability questions.
SARS-CoV-2 Testing Over the Course of Viral Infection
COVID-19 Serology Testing
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Platelia anti-SARS-CoV-2 IgG Quant Assay
The Platelia anti-SARS-CoV-2 S IgG Quant assay is an immunoassay for the quantitative determination (BAU/mL) of anti-spike IgG antibodies to SARS-CoV-2. Clinicians are able to identify individuals with an adaptive immune response to SARS-CoV-2 following SARS-CoV-2 infection or COVID-19 vaccination with vaccines that specifically generate anti-S immune responses. This test is CE-marked.
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Platelia SARS-CoV-2 Total Ab Assay
The Platelia SARS-CoV-2 Total Ab assay detects total anti-nucleocapsid antibodies (IgM, IgA, and IgG) to SARS-CoV-2 with high sensitivity (92% sensitivity for patients tested ≤8 days after symptom onset and 100% for patients tested >8 days after symptom onset).
This blood-based immunoassay, designed for in vitro diagnostic testing, is the first serology assay with U.S. Emergency Use Authorization to test for total antibodies in a single assay. The test has also met requirements for applying the CE-mark in Europe.
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BioPlex 2200 SARS-CoV-2 IgG Panel
The BioPlex 2200 SARS-CoV-2 IgG Panel simultaneously screens and differentiates four individual SARS-CoV-2 IgG antibodies within a single test. The quantitative results for receptor-binding domain (RBD), spike 1 (S1), and nucleocapsid (N) antibodies are traceable to the WHO SARS-CoV-2 International Standard. The panel also provides semi-quantitative spike 2 (S2) results as well as a composite qualitative positive/negative result. The BioPlex 2200 SARS-CoV-2 IgG Panel provides unique serological response profiles for natural infections and vaccinations within a single test, on a fully-automated random access platform.
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VIROTROL SARS-CoV-2 and VIROCLEAR SARS-CoV-2 for SARS-CoV-2 Antibody Laboratory Testing
To ensure an unbiased independent assessment of a laboratory's test systems, we offer VIROTROL and VIROCLEAR SARS-CoV-2 antibody controls. These ready-to-use, liquid controls are formulated from human plasma to test on total IgG/IgM and IgG antibody assays. VIROTROL and VIROCLEAR SARS-CoV-2 are available in three separate classes specifically designed to challenge the assay cutoff of a broad range of methodologies. Laboratories can achieve greater confidence in patient test results by running independent SARS-CoV-2 quality controls with their SARS-CoV-2 antibody assays.
Legal Notice:
The Platelia SARS-CoV-2 Total Ab Assay has been authorized by the FDA under an EUA for use by authorized laboratories. The test has not been FDA cleared or approved. The test has been authorized only for the presence of total antibodies against SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The Platelia SARS-CoV-2 Total Ab Assay has also met requirements for applying the CE-Mark in Europe and other certifications throughout the world (Brazil ANVISA, Health Canada, Singapore HSA, etc.).
PLATELIA is a trademark of Bio-Rad Europe, GmbH in certain jurisdictions.
BIO-RAD, BIOPLEX, VIROTROL, and VIROCLEAR are trademarks of Bio-Rad Laboratories, Inc in certain jurisdictions.