Molecular diagnostic firm Immunexpress has announced that a new study has validated SeptiCyte RAPID as a triaging tool for COVID-19 patients. The study validated the tool for identifying Covid-19 patients who need hospitalization and potentially ICU care. The study was carried out at Hospital del Mar in Barcelona, Spain.
Samples for the trial were collected within 48 hours of intake from 146 subjects hospitalized between July and December 2020. These patients had proven SARS-CoV-2 infections along with clinical signs of COVID-19 disease. Investigators assessed SeptiCyte RAPID as a tool to determine the severity of the disease and forecast requirements for ICU admission. By classifying patients as having critical, severe, moderate or mild COVID-19 under World Health Organization (WHO) guidelines, retrospective clinical evaluation was used as a comparator.
According to the company, SeptiCyte RAPID could stratify COVID-19 cases according to the severity guidelines with a discrimination power significantly better than conventional laboratory tests, such as CRP, lactate, creatine, IL-6 and D-dimer. In the study, it was found that when used within 48 hours of intake, the tool was able to accurately discriminate critical or severe patients, who needed later admission to ICU, from mild patients, who did not need ICU care, with AUC and p values of 0.93 (p<0.0001) and 0.85 (p=0.0003), respectively.
Immunexpress CEO Rollie Carlson said, “hospitals are in need of a rapid and accurate assessment of infectious disease severity for patient outcome and optimal intensive care capacity management. With an infection-based disease like COVID-19 that has the potential to impede lung function and lower blood oxygen levels to dangerous levels at a startling rate, it is essential that patients are accurately triaged and monitored upon hospital intake.”
Immunexpress has already secured CE mark for SeptiCyte RAPID as a near-patient sample-to-answer test in the European Union (EU) member countries. It has also secured US Food and Drug Administration (FDA) clearance for use in hospitalized patients suspected of sepsis.
REFERENCE: Medical Device Network; 03 FEB 2023; Annett Klinger / Paxabay