FebriDx® Bacterial and Non-Bacterial Point-of-Care Diagnostic Assay, CLIA Only, pack/25

The FebriDx® test is not for home or self-testing. FebriDx can only be shipped to facilities who are CLIA certified for moderately complex testing. Documentation will be required prior to shipment.

Bacterial or non-bacterial infection?

FebriDx aids in the differentiation between bacterial infection and non-bacterial etiology.

Acute respiratory infections, causing symptoms such as common cold, sore throat, cough, congestion and runny nose, are the most common reason for seeking medical advice and antibiotic prescriptions. Differentiating between bacterial infection and non-bacterial etiology can be challenging due to an overlap in signs and symptoms of bacterial and non-bacterial infections. The majority of acute respiratory infections are caused by viruses and do not require antibiotics, yet antibiotics are prescribed in up to 50% of cases. Antibiotic resistance continues to remain a major global health threat contributing to 2.8 million antibiotic-resistant illnesses and 35,000 deaths each year in the U.S.

FebriDx is a rapid point-of-care test that uses a fingerstick blood sample to aid in the differentiation between bacterial infection and non-bacterial etiology. FebriDx is intended to be used in urgent and emergency care settings. Knowing whether a patient has a bacterial infection has a direct impact on reducing unnecessary antibiotic prescriptions, limiting the spread of antibiotic-resistant bacteria, and helping providers know when to initiate treatment. FebriDx test results are intended to be used in conjunction with other clinical and diagnostic findings as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology. The assessment of whether a bacterial infection is present should always be based on consideration of all available information, and not based solely on the FebriDx test results. FebriDx test results are not intended to identify a specific pathogen or the severity of infection.

• Results after 10 minutes increases confidence in whether or not to prescribe an antibiotic.
• Highly sensitive/specific dual biomarker technology provides reliable differentiation of bacterial and non-bacterial infections.
• All-in-one, instrument-free test device means no expensive equipment and a fully portable solution.

FebriDx Bacterial/Non-Bacterial Point-of-Care Assay is a qualitative visually read rapid immunoassay for the detection of human host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) directly from fingerstick blood. FebriDx is indicated for use in patients aged 12-64 who present to urgent care or emergency care settings for evaluation of acute respiratory infection who have had symptoms for less than 7 days and within 3 days of fever onset.

The FebriDx test includes a built-in sample collection and transfer tube and detects the presence of MxA and CRP in fingerstick blood specimens using lateral flow technology. A sample of the fingerstick blood is added to the lateral flow test Instructions for Use FebriDx Bacterial / Non-Bacterial Point-of-Care Assay For in vitro diagnostic use. Rx only. A black line present in the result window indicates a positive result (bacterial) and a red line in the result window or the absence of a line in the result window indicates a non-bacterial etiology, i.e., negative for bacterial infection. FebriDx simultaneously detects MxA at the medical decision point of approximately 40 ng/mL and CRP of approximately 20 mg/L serum equivalent.

MATERIALS PROVIDED

• 25 Single Use Test Devices
• 1 Package Insert
• 1 Quick Reference Instruction

SUMMARY & EXPLANATION - Acute respiratory infections (ARIs) including sinusitis, pharyngitis, bronchitis, and influenza are the most common reason for physician office visits and antibiotic prescriptions worldwide.1-3 The significant overlap in symptoms and signs makes it challenging for physicians to differentiate bacterial infections from non- bacterial etiology to identify which patients require antibiotic therapy. The vast majority of ARIs are caused by non-bacterial etiology, for which antibiotics provide no clinical benefit, however 30-80% receive antibiotics. The over prescription of antibiotics for ARI is a leading contributor to the global antimicrobial resistance (AMR) crisis which currently causes 700K deaths annually. FebriDx utilizes dual biomarker technology to deliver high sensitivity and specificity to differentiate a bacterial infection from non-bacterial etiology.

BIOMARKERS MxA - (Myxovirus resistance protein A) MxA is an innate host response biomarker that elevates in the presence of acute viral infection but is not specific to a particular type of virus. MxA has a low basal concentration of less than 15 ng/mL, a fast induction time of 1-2 hours, and a long half-life of 2.3 days.6 Numerous clinical studies demonstrate that MxA protein expression in peripheral blood has been shown to be a sensitive and specific marker for viral infection.7-10 MxA is specific for viral infection only and is not elevated in the presence of a bacterial infection.

CRP (C-reactive protein) - CRP is a nonspecific, acute-phase protein that is upregulated during the presence of acute inflammation, including response to infection. CRP is predominately produced by the liver in response to inflammatory cytokines such as IL-6 and assists in pathogen recognition and phagocytosis by macrophages.11 Infection is a potent stimulus of CRP elevation, which occurs within 4-6 hours of infection, doubles every 8 hours and peaks after 36 hours.12 At low levels CRP is sensitive but non-specific for bacterial infection.

Multiplexed Pattern of Results - Neither MxA nor CRP alone is sensitive or specific enough to differentiate bacterial infection from non-bacterial etiology in symptomatic patients being evaluated for acute respiratory infection. However, when both host response biomarkers are used together in the FebriDx test, bacterial infection can be differentiated from nonbacterial etiologies.

TEST RESULTS
Wait for at least 10 minutes after pressing the buffer release button to read result lines. Results should not be read if blood has not cleared the result window, which may take longer than 10 minutes. Do not read the test results after 1 hour or if blood is not visible in the clearance window

LIMITATIONS
1. The FebriDx test should be used within three (3) days from onset of a fever and less than seven (7) days of new respiratory symptoms.
2. The clinical study was not adequately powered to demonstrate performance among different age groups. Clinical performance has not been established in pediatric patients younger than 12 years old or in elderly patients above 64 years old. The FebriDx test should not be used in these patient populations.
3. The clinical study was not adequately powered to evaluate performance differences in specific races and ethnicities; therefore, results should be interpreted in conjunction with clinical assessments and other diagnostic findings.
4. The FebriDx® test is used in conjunction with clinical assessments and other laboratory findings as an aid to diagnose bacterial infection in patients presenting with symptoms of an acute respiratory infection to urgent care or emergency care settings. The assessment of whether a bacterial infection is present should always be based on
consideration of all available information, and not based solely on the FebriDx test results.
5. Predictive values of the FebriDx test depend on the likelihood ratios and the prevalence of disease.
6. Fresh capillary blood (fingerstick) must be used on the FebriDx test. Venous blood, serum and/or plasma cannot be used.
7. The blood collection tube must be filled completely and transferred to the test strip for the test to run properly. An erroneous result may occur if an insufficient blood sample is applied to the test.
8. Reading results before the blood clears the result window or after 1 hour may produce erroneous results.
9. Clinical performance has not been established in the following populations:

• Patients who are immunosuppressed or those receiving immunosuppressive or chemotherapeutic drugs
• Patients receiving anti-infective drugs
• Patients receiving interferon therapy
• Patients receiving live viral immunization within the last 30 days
• Patients with chronic symptoms or fevers lasting more than 7 days
• Patients without symptoms of acute respiratory infection

10. Interference testing indicated Rheumatoid Factor may contribute to false negative and false positive results at
levels above 50 IU/mL.