Elecsys(R) IL-6 (Interleukin-6) immunoassay receives Emergency Use Authorization
Dear Valued Customer,
On June 2, 2020, Roche Diagnostics received Emergency Use Authorization for the Elecsys® IL-6 (Interleukin-6) immunoassay to further support the fight against COVID-19.
This in vitro assay uses serum and plasma to assist in identifying severe inflammatory response in patients with confirmed COVID 19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Clinical laboratories can run the test on Roche’s cobas e 411, e 601, e 602, and e 801 analyzers. These fully-automated systems provide IL-6 test results in approximately 18 minutes. The Elecsys IL-6 is the first and only FDA reviewed IL-6 assay available in the market.
Elevated circulating concentrations of IL-6, a key mediator of inflammation, can serve as an early alarm signal of SARS-CoV-2 infection-triggered hyperinflammation, helping clinicians identify this hyperinflammatory process in severely ill COVID-19 patients. A subset of these severely ill COVID-19 patients may experience rapid deterioration and need for mechanical ventilation due to the development of Acute Respiratory Distress Syndrome (ARDS).1,2,3,4
As COVID-19 cases resurge throughout the United States, ensuring the right patients receive the right treatment at the right time is as important as ever. The Elecsys IL-6 test enables clinicians to get timely results to help make an objective, rapid decision for ventilator resource allocation.5
To learn more about how IL-6, along with other biomarkers, can be used to assist in the management of critically ill COVID-19 patients and mechanical ventilation decision making, please attend one of the upcoming webinars hosted by Roche Medical and Scientific Affairs.
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 - This test has been authorized by FDA under an EUA for use by authorized laboratories - This test has been authorized only to assist in identifying severe inflammatory response, when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID‑19 patients - This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb‑3(b)(1), unless the authorization is terminated or revoked sooner
1. Jose RJ. (2020). Lancet Resp Med. doi: 10.1016/S2213-2600(20)30216-2
2. Mehta P, et al. Lancet. (2020). 395:1033-4
3. Herold T et al. J Allerg and Clin Immunol (2020), doi: https://doi.org/10.1016/j.jaci.2020.05.008
4. Ye Q et al J Infect (2020) doi:10.1016/j.jinf.2020.03.037
5. Elecsys IL-6 Package Insert 2020-06, V1.0; Material Numbers 05109442190 and 07027532190