Actim SARS-COV-2 Notice D'utilisation page 6

Diagnostic performance
Actim SARS-CoV-2 test was evaluated at University of Turku, Department of
Virology, Finland. The results are shown in FIG 1. and FIG 2. on the inner back
cover.
Actim Influenza A&B
Analytical Sensitivity
The analytical sensitivity of Actim Influenza A&B test was assessed using
different influenza viral strains. The detection limit of influenza virus is
1.0 x 10 TCID /ml for influenza A/New Caledonia/20/99 (H1N1), 1.0 x 10
4
50
TCID /ml for influenza A/Panama/2007/99 (H3N2) and 2.5 x 10
50
for influenza B/Yamanashi/166/98. The test has further been shown to detect
cultured avian influenza A subtypes (H5N1, H5N3, H7N3, H7N9, H9N2).
Analytical Specificity
Actim Influenza A&B test was evaluated with the microorganisms listed below. A
negative test result was obtained with all microorganisms. Test results indicate
that Actim Influenza A&B test is specific for influenza A and influenza B.
Viruses/Bacteria (≥10,000 TCID /ml)
50
• Echovirus types 2, 3, 6, 9, 11, 25, 30
• Adenovirus types 1, 2, 3, 4, 5, 6, 7, 10, 18
• Parainfluenza types 1, 2, 3
• Coxsackievirus types A9, B5, B6
• Rhinovirus types 1A, 2, 13, 15, 37
Bacteria/Yeast (≥10 cfu/ml)
5
• Bordetella pertussis
• Bacteroides fragilis
• Neisseria gonorrhoeae
• Neisseria meningitidis
• Haemophilus influenzae
• Candida albicans
• Streptococcus viridians
• Streptococcus pneumoniae
• Listeria monocytogenes
• Streptococcus pyogenes
• Streptococcus agalactiae
• Streptococcus ssp. Group C
6
EN
TCID
4
50
• Respiratory syncytial virus (RSV) types A and B
• Cytomegalovirus AD169
• Herpes simplex virus types 1 and 2
• Mycoplasma pneumonia (>10,000 CFU)
• SARS-CoV-2 nucleoprotein (10 µg/ml)
• Human coronavirus NL63 (14.2 µg/ml)
• Streptococcus ssp. Group G
• Moraxella catarrhalis
• Enterococcus faecalis
• Staphylococcus Aureus ATCC 25923
• Staphylococcus epidermidis
• Klebsiella pneumoniae
• Pseudomonas aeruginosa
• Escherichia coli
• Proteus mirabilis
• Staphylococcus aureus ATCC 29213
• Staphylococcus aureus ATCC 43300
Repeatability and Reproducibility
A panel of specimens consisting of samples of influenza A (low positive and high
positive), samples of influenza B (low positive and high positive) and a negative
sample was evaluated for intra- (repeatability) and inter- (reproducibility) assay
precision. For repeatability the samples were tested with 10 replicates during
the same day using one lot of the Actim Influenza A&B test. For reproducibility,
the samples were tested on 7 days using one lot of the Actim Influenza A&B
test. One hundred percent (100%) agreement with expected test results was
obtained.
4
Interfering Substances
/ml
Nasal drops (30 %) and ibuprofen (15 mg/ml) were tested with Actim Influenza
A&B test. No interference of these substances was observed with the test
performance. Whole blood was tested with Actim Influenza A&B test. No
interference of whole blood (2%) was observed with the test performance.
Diagnostic Performance
Actim Influenza A&B test was evaluated at Institute of Medical & Veterinary
Science, Adelaide, Australia and at University of Turku, Department of Virology,
Finland. The results are shown in FIG 3. and FIG 4. on the inner back cover.