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SARS-CoV-2 Total AssaySecure your community with science and scale

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.

The COV2T assay produces results in as little as 10 minutes on the Atellica® IM Analyzer with a capacity to process up to 440 assays per hour† with the sensitivity and specificity laboratories have come to expect from us.

COV2T Assay

System

Sensitivity‡

Specificity

Atellica IM

100%

99.82%

ADVIA Centaur XP/XPT

100%

99.81%

“As one of the leading specialized laboratories, we recognized the critical need of our customers to have rapid and accurate testing to manage COVID-19 amongst their patients and staff. The Siemens Healthineers total antibody test enables us to confidently deliver fast, reliable results that will be extremely valuable in the surveillance of the disease.”

Paul F. Beyer, CEO of Ascend Clinical

The Science

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.

The Scale

SARS-CoV-2 key visual

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:

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.

†Dependent on test mix.

‡ For samples collected ≥21 days after positive PCR result. At ≥15 days after positive PCR result, sensitivity of the assay is 98.51% on Atellica IM and 98.73% on ADVIA Centaur XP/XPT.

§ Installed base of ADVIA Centaur® XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica® Solution, Dimension Vista®, and Dimension® EXL™ analyzers.

References:

1

Chen X, et al. Cellular & Molecular Immunology. 2020 Apr. https://doi.org/10.1038/s41423-020-0426-7