High-throughput SARS-CoV-2 Antigen Assay
Lab-based antigen testing for rapid virus detection: Time to first result in as little as 26 minutes
High-throughput, central lab-based SARS-CoV-2 antigen testing is a cost-effective and highly scalable complement to molecular RT-PCR diagnostic testing in the fight against COVID-19 by:
- Increasing testing capacity to support testing of large groups and organizations.
- Detecting positive cases quickly, allowing timely follow-up and implementation of protective measures.
- Providing accurate results, including for patients who are asymptomatic or in the early stage of the disease.
- Protecting your laboratory staff by inactivating the virus with a pretreatment.
The SARS-CoV-2 Antigen Assays are available on the Atellica® IM Analyzer and ADVIA Centaur® XP/XPT Systems.
Download our new white paper
Importance of Monitoring Emerging SARS-CoV-2 Variants to Ensure Antigen Assay Effectiveness White Paper
Monitoring Emerging SARS-CoV-2 Variants
The continued emergence of broadly-circulating SARS-CoV-2 variants has raised significant concerns about vaccine efficacy.1-3
This new whitepaper discusses the differences between mutants, variants, and strains, and how they might affect SARS-CoV-2 antigen testing. Learn about Variants of Concern (VOCs) and how enhanced surveillance supports earlier identification.
Because of their increased risk to public health, Siemens Healthineers is committed to the continuous monitoring of emerging variants and conducting evaluations to help ensure that our assays remain effective at detecting them. Our SARS-CoV-2 Antigen assay features antibodies that maximize variant detection, including the Omicron and Delta variants.
Large Scale Testing
Demand for testing continues to increase, placing great pressure on large organizations and communities to efficiently identify COVID-19 infection. Lab-based antigen testing can be easily integrated on currently available high-throughput instruments already being used for routine diagnostic testing at clinics, reference labs, and hospitals today or can be installed at a mass testing site.
Suspected COVID-19 outbreaks
- In remote settings, institutions, and semi-closed communities where PCR is not immediately available.
- Positive results from multiple patients may suggest an outbreak and would allow for earlier implementation of infection control measures.
Domestic and International Traveler Testing
- Efficient and scalable passenger testing for airports, train stations, and cruise ships.
- More effective identification of at-risk individuals to rapidly isolate positive cases (and initiate other contact tracing efforts) and prioritize sample collection for PCR confirmation as needed.
Large Organizations and Facilities
- Ongoing monitoring to help prevent widespread infection within institutions and workplaces such as schools, offices, dormitories, factories, correctional institutions, medical facilities, etc.
- Areas of widespread community transmission where the positive predictive value and negative predictive value of an antigen result are sufficient to enable effective infection control.
Siemens Healthineers SARS CoV-2 Antigen Tests
- Enable high-volume capacity for testing large organizations and crowded facilities
- Produce accurate results with rapid turnaround time, at reduced costs
- Provide automated result reporting
Now available on the Atellica® IM Analyzer and ADVIA Centaur® XP/XPT Systems, with over 9,000 high-throughput analyzers worldwide4
Atellica IM SARS-CoV-2 Antigen Assay
Time to first result: 26 minutes5
200 tests per hour6
ADVIA Centaur SARS-CoV-2 Antigen Assay
125 tests per hour6
Assay Details
Sensitivity: Positive Percent Agreement with RT-PCR Method8
Nasopharyngeal Swab Samples (Ct<30) from Symptomatic Patients
Nasopharyngeal Swab Samples (Ct<30) from Asymptomatic Patients
Anterior Nasal Swab samples (Ct<30) from Symptomatic Patients
Anterior Nasal Swab samples (Ct<30) from Asymptomatic Patients
Specificity: Negative Percent Agreement with RT-PCR Method
Nasopharyngeal Swab Samples from Symptomatic Patients
Nasopharyngeal Swab Samples from Asymptomatic Patients
Anterior Nasal Swab samples from Symptomatic patients
Anterior Nasal Swab samples from Asymptomatic patients
We are committed to supporting frontline and healthcare professionals and helping them to deliver high-value critical care to patients at each stage of COVID-19 disease management: diagnosis, prognosis, therapy, and follow-up. Learn more.
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Installed base of ADVIA Centaur XP, ADVIA Centaur XPT, and Atellica Solution analyzers.
Analytical time: time to generate a result on the cartridge or on the Atellica Solution or ADVIA Centaur System
Dependent upon test mix. Atellica IM SARS-Cov2Ag assay throughput is 200 tests/hour. ADVIA Centaur SARS-CoV2Ag assay throughput is 125 tests/hour.
Dependent upon test mix.
Positive percent agreement (Sensitivity) and negative percent agreement (Specificity) were determined by testing a total of 1085 nasopharyngeal (NP) and anterior nasal (AN) swab samples on the Atellica IM Analyzer and 1,073 samples on the ADVIA Centaur systems collected from symptomatic individuals suspected of COVID-19 within 7 days of symptom onset and from asymptomatic individuals with cycle threshold (Ct) values up to 40 and in accordance with CLSI Document EP12-A2.
The NP and AN swab samples were collected in UTM/VTM and stored frozen between the time of collection and testing. Samples were thawed and inactivated using the CoV2Ag Sample Lysis Reagent and tested with the Atellica IM CoV2Ag assay or the ADVIA Centaur CoV2Ag assay. The results were compared to RT-PCR results.