SARS-CoV-2 / COVID-19 Antibody Detection

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.

Some products have limited regional availability. Please contact your local sales office for any product availability questions.

COVID-19 Immunoassay Testing

Platelia SARS-CoV-2 Total Ab Assay

This assay will help to determine those who have been exposed to SARS-CoV-2 and those who have developed an adaptive immune response to the virus. A highly specific test is essential for COVID-19 Total Antibody detection.​

The Platelia SARS-CoV-2 Total Ab assay is intended for the detection of total anti-nucleocapsid antibodies (IgM, IgA, and IgG) to SARS-CoV-2 for laboratories with automated or manual immunoassay testing systems. In one test, the assay helps identify the immune response to SARS-CoV-2.

Performance

In clinical tests, the Bio-Rad Platelia SARS-CoV-2 Total Ab test demonstrated >99% specificity for SARS-CoV-2 while showing no cross-reactivity to non-SARS coronaviruses or other medical conditions. In a study of PCR-positive patients, the assay detected antibodies in 100% of patients that had samples collected and tested between 9 and 22 days after onset of symptoms.

Authorizations

This blood-based immunoassay, designed for in vitro diagnostic testing, is one of the first total antibody assays to have obtained U.S. Emergency Use Authorization to test for total antibodies (IgM, IgA, and IgG) in a single assay. In addition, the test has met requirements for applying the CE-mark in Europe.​

FDA Emergency Use Authorization

This test 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.

For more information download the IFU.

Platelia SARS-CoV-2 Total Ab Assay

Catalog #12013798 — Platelia SARS-CoV-2 Total Ab, 480 tests
Catalog #72710 — Platelia SARS-CoV-2 Total Ab, 96 tests

Learn more about our Platelia SARS-CoV-2 Total Ab assay, testing instruments, and world-class technical support.

Contact a Sales Specialist

EVOLIS Automated Testing Platform

The Platelia SARS-CoV-2 Total Ab assay can be used with automated and manual immunoassay platforms for the detection of anti-SARS-CoV-2 IgM, IgA, IgG. The assay is recommended for use on the validated Bio-Rad EVOLIS System and manual systems (PR4100/PW41/IPS), and it can also be run on other validated manual and automated platforms.