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  5. White Paper: Clinical Performance of the Atellica IM SARS-CoV-2 Total Assay

The Value of SARS-CoV-2 Antibody TestingClinical Performance of the Atellica® IM SARS-CoV-2 Total Assay White Paper

One of the principles Healthineers around the world live by is “we don’t compromise on quality.” We were relentless in upholding this principle while developing our SARS-CoV-2 antibody assays and now independent performance evaluations have confirmed the high performance of the assays.

In a recent head-to-head evaluation of four commercial antibody tests, the Siemens Healthineers SARS-CoV-2 Total assay* was the only test that met both sensitivity and specificity targets.1

Learn more about our SARS-CoV-2 antibody assays and review performance data.

1

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

*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 from country to country and is subject to varying regulatory requirements.