Beckman Coulter 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). 

It 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, and Cristian Morales Indiano, 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 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 pathway. 

Shamiram R. Feinglass, chief medical officer for Beckman Coulter, said: “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. 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.”