May 2 letter to customers regarding new serology test
Dear Valued Customer:
On May 2, 2020, Roche Diagnostics received Emergency Use Authorization for the Elecsys® Anti-SARS-CoV-2 immunoassay.
This in vitro test uses human serum or plasma (Heparin or EDTA) and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Hospitals and reference laboratories can run the test on Roche’s cobas e 411, e 601, e 602, and e 801 analyzers. These fully-automated systems provide SARS-CoV-2 antibody test results in approximately 18 minutes.
Clinical data for this antibody test*:
During this global pandemic, demand for this vital serology test is certain to outpace supply. In alignment with the government, we’ll prioritize labs that can implement quickly and enable the broadest geographic reach. We’ll work to meet demand by scaling global production rapidly in an effort to expand broader access as quickly as possible.
Our teams are working around the clock to manufacture, ship and distribute the Elecsys® Anti-SARS-CoV-2 immunoassay to customers around the globe. We appreciate your critical work to support the national healthcare response to COVID-19 and are honored to play a role in supporting you.
If you have any questions, please contact your Roche representative.
With gratitude and partnership,
Your Roche Diagnostics Team
- This test has not been FDA cleared or approved;
- Warning: Not for use for screening donated blood.
- 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 the emergency use of in vitro diagnostic tests 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