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.
SARS-CoV-2 Total AssaySecure your community with science and scale
Assay Specifications
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
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
We smartly selected the receptor-binding domain (RBD) of the S1 spike antigen, the most unique portion of the SARS-CoV-2 virus.
The Atellica IM and ADVIA Centaur COV2T assays* detects IgG and IgM antibodies to the S1 RBD antigen.
The Scale
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.
“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
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*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 ≥15 days after positive PCR result
§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
