NEW YORK (360Dx) – RPS Diagnostics announced today its updated FebriDx test for identifying clinically significant underlying febrile acute respiratory infections has received CE marking.
The point-of-care test, which is used to help differentiate viral from bacterial infections and provides results in 10 minutes, can now be marketed in the European Union and other countries that recognize the CE mark.
The updated FebriDx test utilizes an all-in-one plastic housing technology and includes a built-in safety lancet, blood collection and delivery system, and integrated push button buffer delivery feature. No additional equipment is necessary to perform the test or interpret results, Sarasota, Florida-based RPS Dx said, adding it demonstrated equivalence of the updated test with the previous CE-marked version of it.
FebriDx allows clinicians to assess a patient's immune response to an acute respiratory infection directly from a fingerstick blood sample and helps differentiate viral from bacterial infections through the detection of both myxovirus resistance protein A, or MxA, and C-reactive protein, or CRP.
MxA is an intracellular protein that is elevated during an acute viral infection while CRP is a nonspecific inflammatory protein that is elevated during any clinically significant infection. By detecting MxA, FebriDx "confers specificity to the test through the combined interpretation of the results," RPS Dx said in a statement. The test, it added, could aid in curbing the overuse of antibiotics.