Access IL-6 Assay

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Empower your laboratory with a menu that matters in the fight against COVID-19. Identify severe inflammatory response earlier and recognize associated risk for intubation with mechanical ventilation in COVID-19 patients with Access IL-6. Adding this objective tool to your laboratory in conjunction with clinical findings and other laboratory testing can aid clinicians and hospitals to:

  • efficiently assess and triage COVID-19 patients earlier
  • better manage both critical patients and valuable resources

This product may not be available in your country or region at this time. Please contact your Beckman Coulter sales representative or distributor for more information.

Access IL-6 is a fully automated, chemiluminescent immunoassay for the quantitative measurement of IL-6 in human serum and plasma (heparin). In conjunction with clinical findings and other laboratory testing, the assay is used to assist in the identification of severe inflammatory response in COVID-19 patients to aid in determining the risk of intubation with mechanical ventilation. Potential benefits may be:

  • Improved resource allocation
  • Potential cost savings e.g., efficient patient disposition
  • Improved patient management

Interleukin-6 (IL-6) levels can contribute to severe inflammatory response or “cytokine storm”

IL-6 is a multifunctional cytokine that may promote inflammation in certain clinical conditions. Complications of COVID-19 can include acute respiratory distress syndrome (ARDS) and multiorgan dysfunction, both are among the leading causes of death in critically ill patients with COVID-19.1 Studies have shown that IL-6 levels are elevated in patients with severe COVID-19 and, in a subset of patients, IL-6 may contribute to the severe inflammatory response, sometimes referred to as “cytokine storm”2,3. As elevated interleukin-6 (IL-6) is a hallmark inflammatory signature seen in patients with COVID-19 ARDS4, its measurement may serve as a useful tool to aid physicians in the early identification of severe inflammatory response and triage of patients at risk for respiratory failure.

When used in conjunction with other clinical findings, Access IL-6 can aid physicians in identification of COVID-19 patients with severe inflammatory response who are at risk for intubation.

The performance analysis below was conducted retrospectively in seventy-five (75) confirmed SARS-CoV-2 patients who presented to the Emergency Department (ED) of a public research hospital in Spain. The data shown were calculated based on a cutoff of 35 pg/mL.5 41 of the 75 (54.6%) patients had a PaO2/FiO2 ratio < 150 mmHg which is indicative of the risk for invasive mechanical ventilation.5

Results and Interpretation6

Access IL-6 Results and Interpretation

PCR-confirmed COVID-19 patients that have Access IL-6 concentration >35 pg/mL at presentation are at increased risk for intubation with mechanical ventilation during their hospitalization. Based on analysis of the data, an IL-6 level above 35 pg/mL accurately identified 85.4%6 of patients who had PaO2/FiO2 ratio <150 mmHg, indicative of the risk for invasive mechanical ventilation. IL-6 values should be used in conjunction with clinical findings and the results of other laboratory parameters. IL-6 values alone are not indicative of the need for intubation or mechanical ventilation.

Access IL-6 is available on all Access platforms, seamlessly integrating into your routine automated workflow and requiring low maintenance to allow you to focus on patient care.

Analytical Measuring Range 2 to 1500 pg/mL
Sample Type/Size Serum or plasma (heparin)/ 110 μL
Time to First Result ~ 35 minutes
20% CV Limit of Quantification ≤ 2 pg/mL
Calibrator Levels 0, and approximately 2.5, 25, 250, 750 and 1500 pg/mL
Open pack stability 28 days
Calibration stability 28 days
Imprecision CV < 12% at IL-6 concentrations > 2 pg/mL
1Liu T. et al., The potential role of IL-6 in monitoring severe case of coronavirus disease 2019. Reprint from medRxiv, 10 March 2020.
2Gao Y. et al., Diagnostic utility of clinical laboratory data determinations for patients with the severe COVID-19. J Med Virol. 2020 Mar 17.
3Liu B, Li M, Zhou Z, Guan X, Xiang Y. Can we use interleukin-6 (IL-6) blockade for coronavirus disease 2019 (COVID-19)-induced cytokine release syndrome (CRS)? Journal of Autoimmunity. 2020 Jul;111:102452. DOI: 10.1016/j.jaut.2020.102452.
4Mehta, P et al. “COVID-19: consider cytokine storm syndromes and immunosuppression.” March 16, 2020. DOI:https://doi.org/10.1016/S0140-6736(20)30628-0
5Herold 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.
6Instructions for Use for Access IL-6 under EUA (Part Number A83733J.) Data on file Beckman Coulter, Inc.