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      COVID-19 Testing

      A full range of antibody, antigen and molecular SARS-CoV-2 tests

      Testing is key for the new normal

      Highly accurate testing at scale is essential as we move into the next phase​ of the pandemic. Whether the testing is done in laboratories across the globe​ or your local pharmacy, those tests must be of the highest quality, enabling safe movement throughout our communities.

      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.

      COVID-19 testing, explained

      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 under the supervision of a healthcare professional.
      COVID-19 testing, explained

      Molecular PCR tests2

      Gold standard for accurate and early detection of infection.3

      • The FTD SARS-CoV-2 Assay was ranked in the top 5 for analytical sensitivity in an FDA comparative study.5
      • 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.6
      COVID-19 testing, explained

      Total and IgG antibody tests2

      Measure persistence of immune response over time with a semi-quantitative result.7

      • 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.8
      • 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.10,11
      • The assays run on a large installed base of ~20,000 analyzers worldwide.12

      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.

      Atellica

      Antibody Testing2

      Our SARS-CoV-2 antibody tests provide a semi-quantitative and/or qualitative result. Semi-quantitative measurements of SARS-CoV-2 antibodies help clinicians assess the level of an individual‘s immune response.

      FTD SarsCoV-2

      Molecular Testing2

      Molecular testing is critical to understanding an infectious​ disease outbreak, and our RT-PCR assay is fundamental to determining current infection.

      POC Testing

      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.​

      1

      Product is under FDA review for Emergency Use Authorization (EUA) and not available for sale in the U.S. Product availability may vary by country. Distributed by Siemens Healthineers.

      2

      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.


      3

      IFCC interim guidelines on molecular testing of SARS-CoV-2 infection. https://doi.org/10.1515/cclm-2020-1412, September 18, 2020.

      4

      Analytical time: time to generate a result on the cartridge or analytical device.

      5

      https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data. Accessed on March 2, 2021.

      6

      https://www.siemens-healthineers.com/molecular-diagnostics/molecular-diagnostics-in-vitro-diagnostics/ftd-sars-cov-2-assay/variants

      7

      Semi-quantitative claims for ADVIA Centaur COV2T have not been reviewed by the FDA and are not available in the US.

      8

      Evaluation of sensitivity and specificity of four commercially available SARS-CoV-2 antibody immunoassays. Public Health England. 2020 Jul. GW-1386

      9

      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.

      10

      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

      11

      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

      12

      Installed base of ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica Solution, Dimension Vista®, and Dimension® EXL™ analyzers.

      15

      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.