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Vivalytic C. auris
– Annex
Table 5 – Tested Substances for Interference
No interference detected
Human whole blood; 1 % (v/v)
Mucin; 5 mg/mL
Mupirocin; 0.2 mg/mL
Nasivin® spray; 0.011 mg/mL
Otri-Allergie spray fluticason; 0.005 mg/mL
hysan® Salinspray; 1 % (v/v)
TobraZid®; 4 μg/mL
WICK VapoRub; 1 % (w/v)
Casein; 5 mg/mL
Cornstarch; 1.25 mg/mL
Desitin ointment; 3.5% (w/v)
Eucerin Anti-Transpirant 48 h Roll-on; 0.1 % (v/v)
Vichy DEO Roll-On Mineral 48h; 5 % (v/v)
Vichy DEO Roll-on anti-stain 48h; 5 % (v/v)
Widmer Deo Roll-on unperfumed; 0.1% (v/v)
Olive oil roll-on deodorant green tea; 1% (v/v)
HIDROFUGAL classic sprayer; 0.1 % (v/v)
LINOLA douche and wash; 7 % (v/v)
Glucose; 11 mg/mL
Lactate; 2.2 mg/mL
Interference was experimentally verified at 3xLoD for Candida auris using a spiking
approach Copan Liquid Amies Elution Swab (ESwab®) supplemented with approxima-
tely 1000 Human Bronchial/Tracheal Epithelial Cells (hPBTEC).
Table 6a – Clinical Sensitivity (PPA) [1] and Specificity (NPA) [2]
for clinical samples and isolates in comparison to MALDI-TOF
(95 % confidence interval, clinical study)
[1] 98.36 % (91.20 – 99.96 %)
[2] 72.22 % (58.36 – 83.54 %)*
* 15 samples were found false positive in comparison to MALDI-TOF testing, even
though for at least 2 of these samples, initially performed pre-characterization using
MALDI-TOF found the samples Candida auris positive.
In total, 61 positive and 54 negative samples were included in the dataset against
MALDI-TOF as the gold standard method. Sensitivity (PPA) of 98.34% could be rea-
ched. Most of the positive results (55) were generated using Candida auris isolates.
These isolates were collected during several outbreaks in Germany. All available
Candida auris clades (I, II, III, IV) were included in the testing.
Table 6b – Clinical Sensitivity (PPA) [1] and Specificity (NPA) [2]
for clinical samples and isolates in comparison to MALDI-TOF
and additional qPCR test (95 % confidence interval, clinical study)
[1] 97.52 % (92.93 – 99.49 %)
[2] 94.79 % (88.26 – 98.29 %)
In total, 121 positive (16 positive clinical samples) and 96 negative samples could
be included in the final dataset. Sensitivity (PPA) was determined to be 97.52 % and
specificity (NPA) was 94.79 %.
Table 7 – Document History
Revision 01
Initial document
Revision 02
European languages have been added.
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