Lumos FebriDx Mode D'emploi page 3

INTENDED USE
FebriDx is a rapid immunoassay for the visual, qualitative, in vitro detection of elevated levels of both Myxovirus resistance
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protein A (MxA) and C-reactive protein (CRP) directly from fingerstick whole blood. The test measures an immune response
to a suspected bacterial or viral infection in patients 1 year of age or older that present within 7 days of new onset respiratory
symptoms consistent with a community-acquired acute respiratory infection.
The FebriDx test aids in the diagnosis and differentiation of bacterial and viral acute respiratory infection. FebriDx
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intended to diagnose any specific bacteria or virus.
The test is intended for professional use and should be used in conjunction with other clinical evidence including laboratory,
radiographic, and epidemiological information.
Negative results do not preclude respiratory infection and should not be used as the sole basis for diagnosis, treatment,
or other clinical and patient management decisions. In addition to utilizing radiography and clinical presentation to aid
in diagnosis, additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and polymerase chain
reaction [PCR]) may be used to confirm the presence of a specific respiratory pathogen.
SUMMARY & EXPLANATION:
Acute respiratory infections (ARIs) including sinusitis, pharyngitis, bronchitis, influenza affect 20% of the population
annually. The significant overlap in symptoms and signs makes it challenging for physicians to differentiate viral from
bacterial infection and to identify which patients require antibiotic therapy. The vast majority of ARIs are caused by viruses,
for which antibiotics provide no clinical benefit, however 30-80% receive 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 viral from
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bacterial ARI.
The ability to rapidly identify viral infections to enable effective cohorting and prevent the spread of infection is a critical
component of infection prevention control. Through differentiation of viral positive and viral negative patients, FebriDx
able to optimise patient isolation decisions and enable accurate cohorting.
BIOMARKERS
MxA (Myxovirus resistance protein A)
MxA becomes elevated in the presence of acute viral infection. 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, making it an ideal marker for viral infection.
clinical studies demonstrate that MxA protein expression in peripheral blood has been shown to be a sensitive and specific
marker for acute viral infection.
CRP (C-reactive protein)
CRP is a nonspecific, acute-phase protein that increases during an inflammatory process, especially following severe
infection. Bacterial infection is a potent stimulus of marked CRP elevation, which occurs within 4-6 hours of infection and
peaks after 36 hours. Some viral infections, including Influenza, Adenovirus and SARS-CoV-2 cause CRP to significantly
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elevate.
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Multiplexed Pattern of Results
In isolation, neither MxA nor CRP alone is sensitive or specific enough to differentiate viral from bacterial infection. At low
levels, CRP is very sensitive but non-specific at confirming a bacterial infection. At high levels, CRP becomes very specific
for bacterial infection but has low sensitivity. MxA is specific for viral infection only and is not elevated in a bacterial
infection. The FebriDx test produces a multiplexed pattern of results by simultaneously detecting elevated levels of MxA
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and CRP together to differentiate viral from bacterial infection.
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The over prescription of antibiotics
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