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AlteraDiagnostics
FebriDx held in clinical gloves
FebriDx® Bacterial / Non-Bacterial Point-of-Care Assay

FebriDx® Rapid Diagnostic Test

A qualitative, visually-read rapid immunoassay for the detection of MxA and CRP directly from fingerstick blood. Differentiates bacterial from non-bacterial acute respiratory infections in 10 minutes at the point of care.

93.2%
Sensitivity
99%
NPV
10 min
Results
FDA ClearedCLIA WaivedCPT: 0442URx Only

Quick order

Each kit contains 25 tests

1 kit × $495$495
Total$495
Estimated reimbursement
25 tests × $41.38$1,034.5
Net revenue+$539.5

A representative will confirm pricing and delivery details.

Features

Designedforrealclinicalworkflows

Instrument-free

No readers, analyzers, or external equipment. The device contains everything needed — lancet, blood collection tube, test strip, and buffer.

10-minute results

From fingerstick to actionable diagnosis in the time of a standard patient visit. Results are visually read — no software or connectivity required.

Room temperature storage

Store between 39–77°F (4–25°C). Individually sealed pouches protect against humidity. Stable until expiration date on packaging.

Built-in quality control

Blue control line confirms proper test flow. Invalid results (no control line) are immediately apparent — discard and retest.

99% NPV

Confidently rule out bacterial infection with 99% negative predictive value. Validated in a 20-site prospective U.S. clinical trial published in JAMA Network Open.

Single-use, no cross-contamination

Each device is individually packaged and used on one patient only. Built-in lancet eliminates the need for separate sharps.

Specifications

Technicaldetails

Test Type
Qualitative lateral flow immunoassay
Biomarkers
CRP (C-Reactive Protein) + MxA (Myxovirus Resistance Protein A)
Sample
Fresh fingerstick capillary blood
Time to Result
10 minutes
Result Stability
Up to 1 hour
Patient Age
12–64 years
Setting
Urgent care and emergency care
Symptom Duration
Less than 7 days, fever within 3 days
Storage
Room temperature, 39–77°F (4–25°C)
Kit Contents
25 single-use test devices, package insert, QRI
Part Number
CP0014
Regulatory
FDA 510(k) cleared, CLIA waived
CPT Code
PLA 0442U
CMS Reimbursement
$41.38 per test
Ordering

ReadytostockFebriDxforyourpractice?

Select the number of kits you need and share your practice details. A representative will confirm pricing and shipping within one business day.

Each kit includes

25 individually-sealed single-use test devices
Quick Reference Instructions card
Full Package Insert

Volume discounts

3+ kits5% off
5+ kits10% off
10+ kits15% off
FebriDx 25-test kit

Order FebriDx

Each kit contains 25 tests

1 kit × $495$495
Total$495
Estimated reimbursement
25 tests × $41.38$1,034.5
Net revenue+$539.5

A representative will confirm pricing and delivery details.

Important safety information

Intended use

For in vitro diagnostic use. Rx only. Indicated for patients aged 12-64 presenting to urgent or emergency care with acute respiratory infection symptoms less than 7 days and within 3 days of fever onset. Results should be used in conjunction with other clinical and diagnostic findings.

Limitations

Clinical performance not established in immunosuppressed patients, those receiving anti-infective or interferon therapy, or patients with chronic symptoms lasting more than 7 days. Fresh capillary blood (fingerstick) must be used. Venous blood, serum, and plasma cannot be used. Not for home or self-testing.