Atellica Solution COV2G SemiQuant Assay Box Contents

SARS-CoV-2 IgG AssaysSecure your community with science and scale

Rapid and accurate antibody testing on a large scale is key to address the challenges of the COVID-19 pandemic. Over time after infection, SARS-CoV-2 IgG antibodies remain the primary antibodies present.¹

Both the Siemens Healthineers Atellica® IM^* and the ADVIA Centaur®^* SARS-CoV-2 IgG (sCOVG) assays measure IgG antibodies to SARS-CoV-2 in the blood to help clinicians assess the level of an individual's immune response over time.

Results can be produced in as little as 25 minutes on the Atellica IM Analyzer, one of the highest throughput analyzers on the market, along with the sensitivity and specificity laboratories have come to expect from Siemens Healthineers.

Assay Performance

SARS-CoV-2 IgG Assay^§

System	Positive Percent Agreement	Negative Percent Agreement
Atellica IM*	95.58%^‡	99.90%
ADVIA Centaur XP/XPT*	96.41%	99.90%

The Science

Smart selection of the S1 RBD antigen

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 sCOVG assays* detects IgG antibodies to the S1 RBD antigen.

Accurate identification of immune response to support long term COVID-19 management

The Atellica IM^* and ADVIA Centaur^* sCOVG assays provide a qualitative (negative/positive) and semi-quantitative (index value) result that enables clinicians to detect the level of IgG antibodies in a patient’s blood sample and assess relative changes over time.

A semi-quantitative IgG result is an important step in the global pursuit to understand immunity. With this numerical value, clinicians will have a baseline and be better equipped to assess changes during an individual’s immune response to the SARS-CoV-2 virus.

Why Specificity Matters

High specificity is crucial for an accurate antibody assay. The U.S. Centers for Disease Control and Prevention guidelines for COVID-19 antibody testing states: “Choosing a test with a very high specificity, perhaps 99.5% or greater, will yield a high positive predictive value in populations tested with low prevalence.”⁴

The Scale

Shaping the future of healthcare – COVID-19 testing

The sCOVG assay enables accurate antibody testing on a large scale for both reference laboratories and acute care settings. The assay produces results rapidly—in as few as 25 minutes on the Atellica IM Analyzer.

We offer hope that the goal of effective management of the threat of COVID-19 is within reach with a global installed base of over 20,000 instruments^§§ and a manufacturing capability to produce over 50 million tests a month..

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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.

^§ Performance claims determined on Atellica IM. Assay performance on ADVIA Centaur XP/XPT is substantially equivalent to Atellica IM. See Instructions for Use for more information.

^‡ 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:

Ni L, et al. Immunity 2020; 52:971-977.e3.doi: 10.1016/ j.immuni. 2020.04.023

Mulligan, MJ et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature 586, 589–593 (2020). https://doi.org/10.1038/s41586-020-2639-4

Corbett KS, et al. SARS-CoV-2 mRNA vaccine design enabled by prototype pathogen preparedness. Nature. 2020. https://doi.org/10.1038/s41586-020-2622-0

Centers for Disease Control and Prevention. Interim Guidelines for COVID-19 Antibody Testing; 2020 August 1 revision. Available from https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html