FebriDx (Part 2)
I previously presented a video on the FebriDx system from RPS Diagnostics (FebriDx-part 1). The company has subsequently partnered with Atomo Diagnostics, an Australian based Biotech company to upgrade their point of care (POC) test from a slide-based assay to a self-contained all in one plastic cartridge assay. The new FebriDx device contains a fingerstick mechanism for piercing the skin, and a collection and transfer mechanism for applying 5 microliters of blood to a lateral flow assay system. In 10 minutes, the test displays a blue control line, and lines that indicate the presence of Myxovirus resistance protein A (MxA-pink line) and C-reactive protein (CRP-grey line). MxA is elevated in patients with febrile respiratory infections. The CRP can be elevated in patients with febrile viral infections as well as bacterial infections. If the device indicates the presence of both MxA and CRP, or MxA alone, the patient has a viral infection. If the CRP protein alone is elevated, the patient has a bacterial infection.
The device is anticipated to cost $15 and will help physicians decide if antibiotic therapy is appropriate for the patient.
FebriDx is currently available for sale in Canada, Europe as well as parts of Asia and will soon enter Clinical Trials in the United States. It is anticipated it should be approved by the FDA within the next two years.
When the FebriDx is available for pediatricians, we will need to decide how accurate and reliable it is in the clinical environment. All POC tests, FebriDx included, need to be scrutinized in clinical studies to determine real world sensitivities and specificities. Pediatricians are already familiar with the CRP test and its utility in facilitating clinical decisions, but to date there are no Clia’88 waived POC CRP tests available in the United Sttes. I can think of many potential scenarios where the FebriDx can be helpful – the child who is well appearing and has diffuse rales on lung exam, the crying child who has suspiciously red tympanic membranes, the well appearing child with a mild sore throat who tests positive for strep and may be a carrier. We will need to wait until the device is available for use to decide on its utility in clinical practice. Once FebriDx becomes available – I will let you know what I think!!!!