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.
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.
IFCC interim guidelines on molecular testing of SARS-CoV-2 infection. https://doi.org/10.1515/cclm-2020-1412, September 18, 2020.
Analytical time: time to generate a result on the cartridge or analytical device.
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data. Accessed on March 2, 2021.
Semi-quantitative claims for ADVIA Centaur COV2T have not been reviewed by the FDA and are not available in the US.
Evaluation of sensitivity and specificity of four commercially available SARS-CoV-2 antibody immunoassays. Public Health England. 2020 Jul. GW-1386
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.
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
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
Installed base of ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica Solution, Dimension Vista®, and Dimension® EXL™ analyzers.
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.