US diagnostics company Beckman Coulter initially gained conditional FDA approval for its Access IL-6 test in October last year
Beckman Coulter’s Access IL-6 (Interleukin-6) test can now be used to help identify the inflammatory immune responses seen in more severe Covid-19 cases, potentially reducing the risk of mechanical ventilation.
The US diagnostics firm is expanding claims relating to its CE-marked assay in light of evidence that IL-6 – the protein measured in this test – is “a strong predictor” of respiratory failure and death in novel coronavirus patients.
Multiple large studies conducted earlier on in the Covid-19 pandemic indicated that, when assessed alongside other laboratory results and a patient’s medical history, IL-6 values higher than 35 picograms per millilitre (pg/mL) in human serum or plasma correlate with a greater clinical severity of SARS-CoV-2 infection.
Beckman Coulter’s fully-automated IL-6 test can therefore help doctors identify a severe inflammatory immune system response, often referred to as a cytokine storm, at an earlier stage, and reduce the risk of a patient requiring intubation via invasive mechanical ventilation further down the line.
The company’s chief medical officer Dr Shamiram R Feinglass, MPH 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.”
The Beckman Coulter IL-6 test
Beckman Coulter – a California-based subsidiary of American healthcare giant Danaher – gained an EUA (emergency use authorisation) from the FDA for its Access IL-6 assay on 1 October 2020.
The fully-automated chemiluminescent immunoassay was developed for the quantitative determination of IL-6 levels in human serum and plasma.
By identifying when levels of this protein in the body are raised – indicating a cytokine storm – the test can improve resource allocation, save costs, and improve patient management, according to Beckman Coulter.
The test is also available on multiple analysers provided by the company, including the Access 2, DxI 600 and DxI 800 systems.
In a statement following the Access IL-6 assay’s EUA approval last year, Dr Joshua Hayden, DABCC, chief of chemistry at Norton Healthcare, said: “Our goal is to keep patients off the ventilator as that’s the best way to help Covid-19 patients.
“IL-6 can help us treat the patient before they need a ventilator. The side effect of this is that we are able to reduce the number of patients on ventilators to preserve capacity if needed in a hospital.”