FebriDx® Bacterial / Non-Bacterial POC Assay
FebriDx is a rapid, self-contained test that uses a simple fingerstick to help differentiate between bacterial and non-bacterial acute respiratory infections.
- FDA 510(k) cleared
About
FebriDx is a rapid, self-contained test that uses a simple fingerstick to help differentiate between bacterial and non-bacterial acute respiratory infections. It uses dual biomarkers—MxA, which signals a viral immune response, and CRP, which rises with bacterial inflammation—to deliver trusted results after 10 minutes. No instruments, lab equipment, or readers required. FDA 510(k) cleared with 99% NPV to confidently rule out bacterial infection.1
1. Shapiro NI, Filbin MR, Hou PC, et al. Diagnostic accuracy of a bacterial and viral biomarker point-of-care test in the outpatient setting. JAMA Netw Open, 2022, 5(10): e2234588.
Specifications
| Product code | P0211 |
|---|---|
| Contents | Integrated single-use test devices (containing lancet, buffer and test strip), instructions for use |
| Tests per kit | 25 |
| Specimen type | Capillary whole blood (fingerstick) |
| Time to result | After 10 minutes |
| Clinical Performance (vs reference methods) | 99% to rule out bacterial infection |
| Biomarkers | MxA (viral biomarker indicating immune response to viral infection) CRP (biomarker associated with acute inflammation) |
| FDA clearance | FDA 510(k) cleared K230917 |
| Shelf Life | 24 months |
| Storage Condition | 39-77ºF (4-25ºC); do not freeze |
Intended Use
FebriDx® is a rapid, self-contained, point-of-care immunoassay intended for the qualitative detection of myxovirus resistance protein A (MxA) and C-reactive protein (CRP) from capillary whole blood samples obtained by fingerstick to aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology.
