Israeli diagnostics player MeMed reported data from a study of more than 500 children and adolescents showing that its blood test can accurately tell the difference between a bacterial and a viral infection.
MeMed's CE-marked ImmunoXpert test measures immune system biomarkers in a blood sample and uses algorithms that recognize patterns to distinguish between viral and bacterial infections. The company aims to cut down on the misuse of antibiotics, which can lead to ineffective treatment of infections and the emergence of antibiotic-resistant strains of bacteria.
The Pathfinder study is an international, external, double-blinded study that involved 597 patients aged three months to 18 years with a suspected acute infection, as well as control patients without infection. The patients included those with respiratory tract infections, urinary tract infections and those with a fever that had no identifiable source, the company said.
The results show that the ImmunoXpert test accurately distinguished between viral and bacterial infections with 94% sensitivity and 90% specificity. The test also bested routine laboratory parameters, such as white blood cell count, which are used to manage patients with infections. The findings are published in the journal Pediatrics.
"[We] found that the test may be applicable to harder-to-diagnose cases, as it assigned a clear diagnosis to the majority of cases where there was no agreement on the underlying cause of infection among three independent senior physicians examining the patient medical records. This is a critical capability as it allows clinicians to use the test confidently even when they are unsure what is causing the infection," said Isaac Srugo, M.D., chief of the pediatric department and director of the microbiology laboratory at Bnai-Zion Medical Center in Israel, who co-led the study.
MeMed is also developing ImmunoPOC, a benchtop system that quickly and accurately differentiates between bacterial and viral infections at the point of care.