Stay ahead of cytokine storm by integrating IL-6 into your COVID-19 testing protocol
Key inflammation biomarker now available on Siemens Healthineers immunoassay systems**
Cytokine storm is a dysregulated systemic immune response to infection associated with severe COVID-19 disease, with potential to cause widescale cellular and organ tissue damage. Lab testing can help clinicians identify patients with SARS-CoV-2 infection who are currently experiencing a severe inflammatory response that may indicate development of a cytokine storm.
The role of IL-6 in COVID-19 testing
The Interleukin-6 (IL-6) assay† is an important tool that can 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. It is an early indicator of inflammatory response to illness or injury. An important mediator of the immune response to pathogens, IL-6 is a member of the cytokine class of chemical messengers that induces both pro- and anti-inflammatory responses. It plays a significant role in the development and escalation of CS in COVID-19 patients.1-3
The integration of IL-6 into COVID-19 testing protocols can help clinicians stay ahead of cytokine storm by assisting in the identification of severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, when used in conjunction with clinical findings.
The Siemens Healthineers IL-6 assay† is available across the U.S. on the ADVIA Centaur® XP, XPT and CP Systems. Outside the U.S., the IL-6 assay is available with the CE mark on the ADVIA Centaur® Systems, Atellica® IM Analyzer and IMMULITE® Systems.
Learn more about the role of IL-6 in COVID-19-induced cytokine storm syndrome.
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Clinical performance
Data from 136 symptomatic COVID-19 patients who presented at a US hospital ED were used to assess clinical performance. Confirmation of SARS-CoV-2 infection was based on RT-PCR results.
Using a cut-off value of 35 pg/mL to predict the need for mechanical ventilation the ADVIA Centaur XP IL-6 assay correctly identified 30 of the 35 patients that required intubation.
- Sensitivity: 85.7% (95% CI = 70.6% to 93.7%)
- Specificity:64.4% (95% CI = 84.3% to 96.9%)
- Positive predictive value: 45.5% (95% CI = 34.0% to 57.4%)
- Negative predictive value: 92.9% (95% CI = 84.3% to 96.9%)
- Prevalence of mechanical ventilation in COVID-19 confirmed, hospitalized patients: 25.7% (35/136).
IL-6 is just one way Siemens Healthineers can help you care for COVID-19 patients.
Learn more about our broad diagnostics portfolio that aids in the prognosis, treatment, and follow-up of COVID-19 patients, including high-quality total antibody,† IgG antibody,† and molecular SARS-CoV-2 tests.†
Our broad, differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation, and infectious disease panels. Blood gas and imaging solutions deliver actionable results that aid clinicians in caring for COVID-19 patients.
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† These tests have not been FDA cleared or approved. They have been authorized by FDA under an EUA for use by authorized laboratories. The molecular (“PCR”) test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The serology (“antibody”) test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. The IL-6 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. 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.
**Available on ADVIA Centaur XP, XPT, and CP.
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
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.
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.