Lumos FebriDx Mode D'emploi page 10

PRECISION AND REPRODUCIBILITY STUDY
Samples were prepared in fresh EDTA whole blood with recombinant MxA and CRP proteins. Six (6) samples, consisting
of a combination of no analyte, C5 and C95 concentrations of MxA and CRP were tested.
were performed by untrained operators at three (3) different sites over five (5) days. The study demonstrates overall
reproducibility among three (3) lots of material, among three (3) separate sites, and among six (6) separate users.
Study
Within Run Reproducibility
Within Day Reproducibility
Within Laboratory Reproducibility
Overall Reproducibility
*One day, one operator. Otherwise within run reproducibility ranged 91.7-100%.
INTERFERING SUBSTANCES
The Interfering Substances Verification Study assessed the impact of substances that might be found in samples on the
analytical specificity and analytical sensitivity of the FebriDx
replicates each of a series of samples that included MxA and CRP at the C95 concentration (i.e. low positive) and negative
levels in whole blood, spiked with interfering substances. Positive and negative interference with the potentially interfering
substances was evaluated by three independent researchers blinded to the sample composition.
The following substances were evaluated on the FebriDx
Test Substance
Acetaminophen
Acetylsalicylic acid
Alcohol
Azithromycin
Biotin
Caffeine
Celecoxib
Cetirizine HCl
Conjugated Bilirubin
Dextromethorphan
Doxycycline
Furosemide
HAMA
Hemoglobin
Ibuprofen
®
test and found to not interfere at the listed test concentrations:
®
Concentration
15.6 mg/dL
3 mg/dL
789 mg/dL
1.11 mg/dL
3500 ng/mL
10 mg/dL
0.879 mg/dL
0.435 mg/dL
40 mg/dL
1.56 ug/dL
1.8 mg/dL
1.59 mg/dL
524.6 ng/mL
1000 mg/dL
21.9 mg/dL
10
Results
83.3*-100%
91.7-100%
96.7-99.2%
97.8%
test. This assessment was performed by evaluating three
Test Substance
Imipenem
Levofloxacin
Loratadine
Nicotine
Oxymetazoline HCl
Phenylephrine
Prednisolone
Protein (total)
Rheumatoid Factor (RF)
Salmeterol
Tiotropium
Triglycerides
Unconjugated Bilirubin
Vancomycin
A total of 1080 determinations
22
Concentration
18 mg/dL
3.6 mg/dL
0.5 mg/dL
0.097 mg/dL
0.09 mg/dL
0.003 mg/dL
0.120 mg/dL
9 g/dL
50 IU/mL
6.03 ug/dL
4.80 ng/dL
1500 mg/dL
40 mg/dL
12 mg/dL