Testing is key for the new normal
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COVID-19 testing, explained
From rapid and large-scale laboratory antigen testing used to diagnose and isolate infected people quickly to the gold standard PCR testing for accurate and early detection through testing for the long-term management and monitoring of disease, there are many options to combat the pandemic and rebuild public confidence.
Rapid antigen tests1
Rapid antigen testing is used to identify and isolate infected people quickly, with no lab equipment required.
- Rapid antigen testing can be performed anywhere that fast results are needed.
- For patients with or without COVID-19 symptoms.
- No laboratory personnel or equipment are required.
- Nasal specimens can be collected by a healthcare provider or self- collected.
- CLINITEST® Rapid COVID-19 Antigen Self-Test also available and is CE Mark-certified for unsupervised self-testing.
Lab antigen tests
Used to identify currently infected people quickly. Enables community testing with fast, high-volume lab equipment and results delivered through automated reporting.
- The laboratory antigen test has high testing capacity, with clinical reach of >9,000 analyzers worldwide.2
- This test features antibodies designed to maximize variant detection, including the Delta variant.
- It can quickly detect positive cases, allowing timely protective measures and appropriate follow up.
Molecular PCR tests4
Gold standard for accurate and early detection of infection.5
- The FTD SARS-CoV-2 Assay was ranked in the top 5 for analytical sensitivity in an FDA comparative study.6
- The FTD SARS-CoV-2 Assay has been confirmed to detect the main variants and clades of SARS-CoV-2 that are currently circulating with a 100% detection rate.7
Total and IgG antibody tests4
Measure persistence of immune response over time with a quantitative result.9
- Antibody tests monitor the long-term duration of the immune response.
- The SARS-CoV-2 Total Assay was recognized by PHE as top-performing antibody assay.10
- The SARS-CoV-2 Total and IgG assays detect antibodies to the receptor-binding domain (RBD) of the S1 spike antigen, the most unique portion of the SARS-CoV-2 virus.11,12
- The assays run on a large installed base of ~20,000 analyzers worldwide.13
Tools for assessing presence of the virus and for assessing immune status
Siemens Healthineers continues to deliver high-value COVID-19 care across disciplines throughout the patient care pathway.
Antibody Testing4
Our SARS-CoV-2 antibody tests provide a quantitative and/or qualitative result. Quantitative measurements of SARS-CoV-2 antibodies help clinicians assess the level of an individual‘s immune response.
Molecular Testing4
Molecular testing is critical to understanding an infectious disease outbreak, and our RT-PCR assay is fundamental to determining current infection.
Point of Care Testing1
As society continues to navigate through the COVID-19 pandemic, there is a critical public health need to get ahead of the spread with a fast and simple test for all.
Lab Antigen Testing
Lab-based antigen testing for rapid virus detection: Time to first result in as little as 26 minutes with the high throughput SARS-CoV-2 Ag (CoV2Ag) assay.
1
In the U.S., CLINITEST Self-Test available for use under Emergency Use Authorization only. Distributed by Siemens Healthineers.
2
Installed base of ADVIA Centaur XP, ADVIA Centaur XPT, and Atellica Solution analyzers.
3
Analytical time: time to generate a result on the cartridge or analytical device.
4
The SARS-CoV-2 molecular and antibody tests have not been FDA-cleared or approved. These tests have been authorized by FDA under an EUA for use by authorized laboratories. The molecular test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The antibody test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. These tests are 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 from country to country and is subject to varying regulatory requirements.
5
IFCC interim guidelines on molecular testing of SARS-CoV-2 infection. https://doi.org/10.1515/cclm-2020-1412, September 18, 2020.
6
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data. Accessed on March 2, 2021.
7
https://www.siemens-healthineers.com/molecular-diagnostics/molecular-diagnostics-in-vitro-diagnostics/ftd-sars-cov-2-assay/variants
8
Turnaround times are calculated based on theoretical analysis with one NUCLISENS EASYMAG and one Thermo Fisher ABI7500; not based on real workflow study. Using more instruments would decrease the total turnaround time.
9
Assays are for semi-quantitative use in the U.S.
10
Evaluation of sensitivity and specificity of four commercially available SARS-CoV-2 antibody immunoassays. Public Health England. 2020 Jul. GW-1386
11
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
12
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
13
Installed base of ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica Solution, Dimension Vista®, and Dimension® EXL™ analyzers.
14
The fingerstick claim has not been reviewed by the FDA and is not available in the U.S. Claims may vary by country and are subject to varying regulatory requirements.