SARS-CoV-2 Total Assay
Rapid and accurate antibody testing on a large scale is vital to address the challenges of the COVID-19 pandemic. The Siemens Healthineers SARS-CoV-2 Total (COV2T) Assay* can be used effectively for broad population testing. There is the potential that broad population testing for antibodies may help re-open society in a smart way.
With mass availability and a large installed base of over 20,000 analyzers,† we are eager to meet the high demand with the sensitivity and specificity laboratories have come to expect from us.
Simplified identification of immune response with a total assay
The COV2T assay detects both IgM and longer-lasting IgG antibodies with high sensitivity of recent and prior infection. This allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.
Smart selection of the S1 RBD antigen to detect antibodies that block virus entry into cells
The COV2T assay uses a proven antibody-bridging assay architecture, which involves binding of a single SARS-CoV-2 antibody to two identical SARS-CoV-2 antigens, helping to avoid false-positive results. The human body produces antibodies against both the nucleocapsid (N) and spike (S) proteins as well as other proteins in the SARS-CoV-2 virus, but to be effective against the virus, the antibodies must be neutralizing.
Tests for detection of antibodies to both the N and S proteins (including the S1 RBD antigen) have been developed and indicate an immune response to infection. Growing evidence indicates that the spike protein antibodies are neutralizing, based on in vitro data.1 Evidence for neutralization antibodies to the N protein is currently sparse.
Siemens Healthineers smartly selected the receptor-binding domain (RBD) of the S1 spike protein to detect antibodies that block the virus entry into the cells. This selection is aligned with the current vaccinations in development that target the spike protein.
Reliable and rapid SARS-CoV-2 antibody testing on a large scale for both reference laboratories and acute care settings
The COV2T assay can be used with a full range of Siemens Healthineers systems such as:
- The Atellica® IM Analyzer*
- ADVIA Centaur® Immunoassay Systems*
- Dimension® and Dimension Vista® systems§
This enables accurate SARS-CoV-2 antibody testing on a massive scale for both reference laboratories and acute care settings. The test produces results rapidly—in as little as 10 minutes on the Atellica IM Analyzer, with a capacity to process up to 440 assays per hour.‡
With a global installed base of over 20,000 instruments and a manufacturing capability to produce over 50 million tests a month, Siemens Healthineers offers hope that the goal of effective management of the threat of COVID-19 is within reach.
*This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This 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. Product availability may vary by country and is subject to regulatory requirements.
†Installed base of ADVIA Centaur® XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica® Solution, Dimension Vista®, and Dimension® EXL™ analyzers.
§This test has not been reviewed by the FDA. In the U.S., use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary by country and is subject to regulatory requirements.
‡Dependent on test mix.
1. Chen X, et al. Cellular & Molecular Immunology. 2020 Apr. https://doi.org/10.1038/s41423-020-0426-7