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.
FebriDx®
Now CLIA waived for near-patient settings
FebriDx is a rapid, self-contained, fingerstick blood test that aids in the diagnosis of acute respiratory infection and helps differentiate bacterial infection from non-bacterial etiology after 10 minutes.
- CLIA waived
- Results after 10-minutes
- Fingerstick blood sample
- Supports testing in urgent care, primary care, and pharmacy clinics
About
Specifications
FAQs
Resources & downloads
Results
Video
Sales & support
About
About
FebriDx is a rapid, self-contained test that uses a simple fingerstick to aid in the diagnosis of acute respiratory infection and differentiate bacterial infection from non-bacterial etiology. It uses dual biomarkers—MxA, which signals a viral immune response, and CRP, which rises with inflammation and infection—to deliver trusted results after 10 minutes. No instruments, lab equipment, or readers required. FDA 510(k) cleared with 99% negative predictive value (NPV) to confidently rule out bacterial infection.1
Specifications
Specifications
| Product code | P0211 |
|---|---|
| Contents | Integrated single-use test devices (containing lancet, buffer and test strip), instructions for use, quick reference guide (QRI) |
| Tests per kit | 25 |
| Specimen type | Fingerstick blood |
| Time to result | After 10 minutes |
| Clinical performance (vs reference methods) | 99% NPV to rule out bacterial infection |
| Biomarkers |
MxA (viral host-response biomarker) CRP (biomarker associated with inflammation and infection) |
| FDA clearance | FDA 510(k) cleared; CLIA waived |
| Shelf life | 24 months |
| Storage condition | 39–77°F (4–25°C) |
Intended use
FebriDx is a rapid, self-contained, immunoassay intended for the qualitative detection of myxovirus resistance protein A (MxA) and C-reactive protein (CRP) from fingerstick blood samples to aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology.
FAQs
Frequently Asked Questions
Why FebriDx?
FebriDx delivers rapid, near-patient insight to support evaluation of acute respiratory infection using a simple fingerstick blood sample. With CLIA waiver and results after 10-minutes, it is designed for practical use across CLIA waived healthcare settings.
What patients can be tested with FebriDx?
Patients ages 12–64 presenting to urgent care, emergency care, primary care, or pharmacy clinic settings for evaluation of acute respiratory infection, with symptoms for fewer than 7 days and within 3 days of fever onset.
What patients samples can be used with the FebriDx test?
Fresh capillary blood (fingerstick) must be used on the FebriDx test. Venous blood, serum and/or plasma cannot be used.
What reimbursement information is available for FebriDx?
PLA0442U: This FebriDx Proprietary Laboratory Assessment (PLA) code is published on the Clinical Lab Fee Schedule, effective January 1, 2025.
When can the FebriDx test results be interpreted?
FebriDx results can be read after 10-minutes. Do not read results after 1 hour. Reading results before the blood has cleared the Result Window or without blood in the Blood Clearance Window may lead to erroneous test results.
What is the negative predictive value (NPV) of the FebriDx test?
FebriDx has a 99% NPV to rule out bacterial infection. Refer to the Instructions for Use (PM-548) for the complete performance data.
What biomarkers are used with the FebriDx test?
FebriDx utilizes proprietary dual biomarker technology: C-Reactive Protein (CRP) and Myxovirus resistance protein A (MxA).
What are the limits of detection for CRP and MxA?
→ CRP: 20 µg/mL
→ MxA: 40 ng/mL
What are the storage conditions for the FebriDx test?
FebriDx tests should be stored at room temperature (4-25°C or 39-77°F).
What is the shelf life for the FebriDx test?
Unopened FebriDx tests are stable up to 24 months from the date of manufacture when stored at a temperature between 39 – 77°F (4 – 25°C).
How many FebriDx tests are in a kit box? In a case?
FebriDx is packaged in a kit box containing 25 tests. There are 100 FebriDx tests (4 kit boxes) per case.
Is the FebriDx test qualitative or quantitative?
The FebriDx test is a qualitative visually read rapid immunoassay.
The result line(s) is visible, but the control line is absent. Can I still report the results?
No. A blue control line must appear in the result window for the test to be valid. The absence of the blue control line indicates an invalid test, and the patient must be retested with a new FebriDx test.
The result line is faint. Does this affect the interpretation of results?
No. Even if the result line is faint in color, incomplete over the width of the test strip or uneven in color, it should be interpreted as present.
My patient has Acute Respiratory Infection (ARI) symptoms, but neither the red nor black result line appears, is the test valid?
Yes. Any test with a red result line (MxA) or no result line and a blue control line is interpreted as a non-bacterial etiology. A blue control line shows that the test is valid. The absence of the blue control line indicates an invalid test.
Are External Controls available for the FebriDx test?
Yes. Contact PHASE Scientific at 657-233-5880 or USsales@phasesci.com to order FebriDx External Controls (P0212).
Does FebriDx support Antimicrobial Stewardship?
Yes. FebriDx aids in the evaluation of acute respiratory infection by helping differentiate bacterial infection from non-bacterial etiology, supporting more informed clinical decision-making and antimicrobial stewardship efforts.
1. FebriDx Bacterial / Non-Bacterial Point-of-Care Assay; Instructions for Use (PM-548); FDA 510(k) K260787
2. Shapiro NI, Filbin MR, Hou PC, Kurz MC, Han JH, Aufderheide TP, Ward MA, Pulia MS, Birkhahn RH, Diaz JL,Hughes TL, Harsch MR, Bell A, Suarez-Cuervo C, Sambursky R. Diagnostic Accuracy of a Bacterial and Viral Biomarker Point-of-Care Test in the Outpatient Setting. JAMA Netw Open. 2022 Oct 3;5(10):e2234588. doi:10.1001/jamanetworkopen.2022.34588. PMID: 36255727; PMCID: PMC9579916.
3. American Hospital Association: https://www.aapc.com/codes/cpt-codes/0442U
Resources & downloads
Results
See the Instructions for Use (PM-548) for complete test procedure details and result interpretation guidance.
- Collect a fingerstick blood sample
(lancet included in device) - Transfer the blood to the test strip via capillary action
- Push the buffer release button
- Read results after 10 minutes
Video
View the latest video content
Sales & support
Questions about FebriDx? Contact Sales or Customer Service
Our team is available Monday–Friday, 5 a.m.–5 p.m. PT.