Roche announced that the US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed Covid-19 disease who could be at high risk of intubation with mechanical ventilation.
According to the press note, the test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed Covid-19 illness requires mechanical ventilation. “The FDA EUA approval of Elecsys IL-6 is another step in our commitment to deliver fast and reliable diagnostic tests to help fight the coronavirus pandemic,” said Thomas Schinecker, chief executive officer Roche Diagnostics. “In the current situation, time is specifically critical. The test could help physicians quickly identify severe inflammatory responses in patients infected with the SARS CoV-2 virus.”
“In the current pandemic, Roche’s Elecsys IL-6 test was helpful as an early indicator for acute inflammation and in the management of critically ill patients,” said Tobias Herold, managing director from the Emergency Department, University Hospital, LMU University Munich, Germany. “Elevated IL-6 values help us to identify patients with a high risk of upcoming respiratory failure.
Hospitals and reference laboratories can run the Elecsys IL-6 test on Roche’s cobas eAnalyzers, which are widely available worldwide. These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.