Atellica Solution COV2G SemiQuant Assay Box Contents

SARS-CoV-2 IgG AssaySecure 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.

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Assay Performance

System

Positive Percent Agreement§

Negative Percent Agreement

Atellica IM

96.41%

99.90%

ADVIA Centaur XP/XPT

96.41%

99.90%

The Science

We smartly selected the receptor-binding domain (RBD) of the S1 spike antigen to detect IgG antibodies to SARS-CoV-2. The selection of the S1 RBD is aligned with multiple high-quality vaccines, either currently available or in development, that target or include the SARS-CoV-2 S1 RBD, with the goal of producing protective antibodies.

The SARS-CoV-2 IgG assays detects IgG antibodies to the S1 RBD antigen.** S1 RBD antibodies are relevant to vaccines incorporating this immunodominant region to elicit neutralizing (and therefore likely protective) antibodies in vaccinated subjects.2 The spike protein and particularly the RBD are the most common target of vaccine designs.3

The SARS-CoV-2 IgG assays provides 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 SARS-CoV-2 lgG assays enable accurate antibody testingon 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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