Staying ahead of cytokine stormThe role of IL-6 in COVID-19 testing
Cytokine storm (CS) is a dysregulated systemic immune response to infection associated with severe COVID-19 disease, with the potential to cause widescale cellular and organ tissue damage. Lab testing can help clinicians identify patients with SARS-CoV-2 infection (COVID-19) who are currently experiencing or at risk of developing CS.
†ADVIA Centaur IL6 assay 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 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. Please contact your local representative for availability.
‡Product availability may vary by country and is subject to regulatory requirements. Not FDA cleared/approved for sale in the U.S.
§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.
**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.
††Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.
1. Shimizu M. Clinical Features of Cytokine Storm Syndrome. In: Cron GR, Behrens EM, editors. Cytokine storm syndrome. Springer Nature Switzerland AG; 2019. https://doi.org/10.1007/978-3-030-22094-5
2. Mahmud-Al Rafat A, Majumder A, Rahman T, et al. Decoding the enigma of antiviral crisis: Does one target molecule regulate all? Cytokine. 2019;115:12-23.
3. Liu T, Zhang J, Yang Y, et al. The potential role of IL-6 in monitoring coronavirus diseases 2019. The Lancet. 2020. DOI: 10.2139/ssrn.3548761.