Lumos FebriDx Mode D'emploi page 7

LIMITATIONS
1. The FebriDx test is best used within three (3) days from onset of a new fever and seven (7) days from onset of
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new respiratory symptoms. Symptomatic patients with suspected COVID-19 may be tested up to 14 days from the onset
of symptoms.
2. Only fresh capillary blood (fingerstick) must be used on the FebriDx
3. The blood collection tube must be filled completely and applied to the test strip in order for the test to run properly.
An erroneous result may occur if an insufficient blood sample is applied to the test.
4. The following conditions may lead to erroneous results:
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Current immunosuppressive state or use of immunosuppressive drugs
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Current use of oral anti-infective drugs
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Current use of interferon therapy (e.g. for multiple sclerosis, HIV, hepatitis B/C)
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Live viral immunization within the last 30 days
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Major trauma, major surgical intervention, and severe burns within the preceding 30 days
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Chronic fevers lasting more than 7 days that are not suspected to be associated with SARS-CoV-2
5. FebriDx will not identify bacterial colonization, localized infections, or periodic viral shedding without an associated
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systemic host response.
6. Rheumatoid Factor (RF) ≥ 100 IU/mL (normal RF: 15 IU/mL) can produce a MxA line in very rare cases.
7. Reading results before 10 minutes or after 1 hour may produce erroneous results.
EXPECTED VALUES
The prevalence of ARI varies during the year and from region to region, with outbreaks typically occurring during fall and
winter. ARIs are the leading cause of morbidity, accounting for 20% of medical consultations, 30% of absenteeism, and
75% of all antibiotic prescriptions.
Nearly half of patients presenting to the outpatient setting with respiratory symptoms do not have infection.
FebriDx test in a symptomatic patient can be indicative of a non-infectious illness e.g., environmental trigger of respiratory
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illness, allergic rhinitis, autoimmune, subclinical, or past infection. Symptomatic patients who had a negative FebriDx
did not have evidence of infection with standard laboratory testing
illness that required treatment.
CLINICAL EVIDENCE
FebriDx has been evaluated in multiple prospective, multicenter, blinded clinical trials with untrained operators to determine
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the diagnostic performance characteristics of the FebriDx
bacterial community-acquired febrile ARI as compared to the reference standard (standardized microbiologic and laboratory
testing adjudicated by clinical experts).
an emergency department (ED) within 3 days of an acute onset fever and within 7 days of new onset respiratory symptoms
consistent with a community-acquired ARI were eligible for inclusion.
Viral testing:
• FilmArray® PCR: Influenza A/B, Adenovirus, RSV, Parainfluenza virus 1-4, Metapneumovirus, non-SARS-CoV-2
Coronavirus, and Rhinovirus
• Supplemental real-time reverse transcriptase PCR for EBV, HSV, and CMV
• EBV IgM Serology
Bacterial testing:
• FilmArray® PCR for atypical bacteria: Chlamydophila pneumoniae, Mycoplasma pneumoniae, Bordetella pertussis,
Fusobacterium necrophorum, Neisseria gonorrhoeaea.
• Oropharyngeal cultures (blood, chocolate, and MacConkey plates)
Laboratory testing:
• Procalcitonin (PCT) and white blood cell count (WBC), lymphocytes and percentage of immature WBC (bands)
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Subjects 1 year of age and older who presented to primary care, urgent care, or
10,16,17
test. Venous blood CANNOT be used.
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nor returned to a healthcare provider with worsening
16,17
test to identify a host immune response and differentiate viral or
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A negative
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result
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