Download our full position statement here.
Siemens Healthineers Position Statement on SARS-CoV-2 Serology Testing in the Setting of Vaccination (pdf)
The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.
1. Ehterinton, D. https://techcrunch.com/2020/03/27/the-fda-just-okayed-multiple-15-minute-blood-tests-to-screen-for-coronavirus-but-there-are-caveats/ (Accessed March 28, 2020)
2. Morris, A. https://www.azcentral.com/story/news/local/arizona-health/2020/03/28/university-arizona-working-tests-detect-covid-19-antibodies/5083093002/ (Accessed March 28, 2020)
3. https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf Accessed July, 27, 2020
4. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html Accessed July 27, 2020
*Under development. Not available for sale. Future availability cannot be guaranteed.
**CE-IVD labeled for diagnostic use in the EU. 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 the detection of nucleic acid from 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.
***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.