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Vivalytic C. difficile
Table 5 – Tested Substances for Interference
No interference detected
For swab samples
Cholesterol; 0.5 % (v/v)
Mucus; 3 mg/mL
Palmitic acid; 2mg/mL
Stearic Acid; 2mg/mL
Triglyceride; 0.8 % (w/v)
Whole blood; 3.0 (v/v)
Barium Sulfate; 1.3 % (w/v)
GLYICILAX for adults; 1.0 % (w/v)
GRÜNWALDER Sennalax film-
coated tablet; 0.1 mg/mL
Hemorrhoid ointment
with witch hazel; 1 % (v/v)
Interference was experimentally verified 3xLoD for C. difficile using a spiking approach
in eNAT® (COPAN) plus 1000 hPBTEC and 6 % (v/v) Stool Matrix Negative Control
(artificial simulated matrix).
Table 6 – Clinical Sensitivity (PPA) [1] and Specificity (NPA) [2] for
samples in eNAT® (95 % confidence interval, clinical study)
[1] 96.61 % (88.29 – 99.59 %)*
[2] 95.24 % (86.71 - 99.01 %)**
Clinical study within total 122 valid results, generated at two study sites and gained
from 63 negative and 59 positive samples. Clinical performance data of Vivalytic
C. difficile in comparison to the reference tests RIDA®GENE Clostridium difficile
(R-Biopharm) on Roche LightCycler 480II device Discrepant results were verified
using Allplex™ GI-Bacteria(I) Assay (5 samples) and Cepheid Xpert® C. difficile BT (5
samples).
*2 samples were detected as false negative.
** 3 samples were detected as false positive.
Table 7 – Document History
Revision 01
Revision 02
– Annex
Initial document
Update including new analytical and clinical
performance data
For urine samples
LOPERAMID-ratiopharm acute 2 mg
film-coated tablet; 0.2 % (v/v)
MAALOXAN 25 mVal Liquid;
0.1 mg/mL
METRONIDAZOL Aristo 400 mg
tablet; 0.5 % (w/v)
Naproxen-ratiopharm® tablet;
0.5 % (w/v)
Nonoxynol‐9; 0.015 % (w/v)
Nystatin STADA®; 1 % (w/v)
Postericort ointment; 0.5 % (v/v)
Claversal 4 g/60 ml clysms;
0.5 % (v/v)
Vancomycin; 1.4 mg/mL
Vaseline; 1 % (w/v)
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