Beckman Coulter’s Interleukin-6 Test Is Now Available for Use in Helping Identify Severe Inflammatory Response in COVID-19 Patients

Beckman Coulter announced that it has expanded claims for its CE-marked Access Interleukin-6 (IL-6) assay. The Access IL-6 assay is an in-vitro diagnostic test for the quantitative determination of IL-6 levels in human serum and plasma (heparin). The fully-automated assay helps physicians identify a severe inflammatory response in COVID-19 patients, often referred to as cytokine storm, and determine the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.

At the beginning of the pandemic, information about the pathophysiology of SARS-CoV-2 led the Laboratory of Clinical Biochemistry (Laboratori Clínic Metropolitana Nord) together with the Emergency Department at Germans Trias i Pujol University Hospital in Badalona, Spain to search for biomarkers that could potentially predict severe responses to COVID-19, such as a cytokine storm.

Carme Garcia Martin, MD and Cristian Morales Indiano, MD of the Laboratory of Clinical Biochemistry (Laboratori Clínic Metropolitana Nord, at Campus Can Ruti in Badalona) said, “The results obtained showed that, when assessed alongside other laboratory results and a patient's medical history, IL-6 values higher than 35 pg/mL correlated with greater clinical severity and the need for invasive mechanical ventilation in patients with SARS-CoV-2. As a result of the studies carried out and the experience gained, we believe that a patient’s IL-6 level is a good indicator of COVID-19 severity, as the values reflect the exaggerated immune response in these types of patients.”

Several large studies^1,2,3 have shown that IL-6, a multifunctional cytokine that promotes inflammation in certain clinical conditions, is a strong predictor of respiratory failure and death in COVID-19 patients. Identifying and treating hyperinflammation can help physicians plan resources and determine the best patient care pathway⁴.

“Our goal is to save lives and help avoid the need for intensive treatments, and we can do that by keeping patients off ventilators, which can ease the recovery for COVID-19 patients" said Shamiram R. Feinglass, MD, MPH, chief medical officer for Beckman Coulter. “This is a significant advance in the treatment of COVID-19. We expect it may obviate the need for and consequences of invasive mechanical ventilation for some patients, while also lowering costs for the health system and improving resource allocation, factors that have often not met the current high demand.”

To learn more about the Access IL-6 assay, or for the latest information on Beckman Coulter’s response to COVID-19, visit www.beckmancoulter.com/coronavirus.

References: 

1 Mehta P, McAuley DF, Brown, M, Sanchez E, Tattersall RS, Manson JJ et al. COVID-19: consider cytokine storm syndromes and immunosuppression. The Lancet. VOLUME 395, ISSUE 10229, P1033-1034. Published: March 16, 2020. DOI: https://doi.org/10.1016/S0140-6736(20)30628-0.
2 Liu T. et al., The potential role of IL-6 in monitoring severe case of coronavirus disease 2019. Reprint from medRxiv, 10 March 2020.
3 Gao Y. et al., Diagnostic utility of clinical laboratory data determinations for patients with the severe COVID-19. J Med Virol. 2020 Mar 17.
4 Herold T, Jurinovic V, Arnreich C, Lipworth BJ, Hellmuth JC, von Bergwelt-Baildon M, Klein M, Weinberger T, Elevated levels of interleukin-6 and CRP predict the need for mechanical ventilation in COVID-19, Journal of Allergy and Clinical Immunology (2020), doi: https://doi.org/10.1016/j.jaci.2020.05.008.