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Vivalytic Bordetella
Table 5 – Tested Substances for Interference
EDTA whole blood; 2 % (v/v)
Aspirin 500 mg; 5 mg/mL
Azithromycin HEXAL® 500 mg; 5 mg/mL
Budesonid Easyhaler® 0.2 mg/Dosis; 25 mg/mL
SILOMAT DMP pastille; 0.1 mg/mL
DOLO-DOBENDAN 1.4 mg/10 mg throat lozenge; 2.5 % (w/v)
Em-eukal classic bonbons; 0.26 % (w/v)
IBU ratiopharm 400 mg akut analgesic tablet; 10 mg/mL
Mometason-ratiopharm® hay fever spray; 2.5 mg/mL
Nasivin® Spray; 10 % (v/v)
Otri-Allergie Spray Fluticason; 5 % (v/v)
Paracetamol ratiopharm 500 mg; 10 mg/mL
Rhinomer nasal spray; 15 % (v/v)
Salbuhexal N 200 puff dosing aerosol; 0.1 % (v/v)
Tamiflu® 75 mg; 3.75 mg/mL
TobraZid®; 4 µg/mL
Turixin®; 10 mg/mL
Vaseline; 1 % (w/v)
DOREGRIPPIN tablet; 0.075 mg/mL
Wick cough solvent sirup; 5 % (v/v)
Interference was experimentally verified at 3x c95 for Bordetella pertussis, Bordetella
parapertussis and Bordetella holmesii using a spiking approach in eNAT® (COPAN)
supplemented with approximately 10.000 Human Bronchial/Tracheal Epithelial Cells
(hPBTEC).
Table 6 – Clinical Sensitivity (PPA) and Specificity (NPA) for
samples in eNAT® (95 % confidence interval, clinical study)
Pathogen
Bordetella
pertussis
Bordetella
parapertussis
Bordetella
holmesii
Total
Table 7 – Document History
Revision 01
Revision 02/03
– Annex
Sensitivity (PPA)
(95%-width of CI)
94.0 %
(83.45 – 98.75 %)
100.0 %
(93.51 – 100.0 %)
100.0 %
(90.97 – 100.0 %)
97.9 %
(94.03 – 99.57 %)
Initial document
Pre-release changes
Specificity (NPA)
(95%-width of CI)
(96.84 – 100.0 %)
(89.71 – 98.51 %)
(93.20 – 99.51 %)
(95.56 – 99.01 %)
167
100.0 %
95.5 %
97.6 %
97.7 %
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