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Table 5 – Tested Substances for Interference
No interference detected
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)
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 axicur® tablet; 0.5 % (w/v)
Nonoxynol‐9; 1 % (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)
Interference was experimentally verified at 3x LoD for Norovirus GII 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] 94.23 % (84.05 – 98.79 %)*
[2] 100 % (95.98 - 100 %)
*3 samples were detected as false negative.
In total, 159 clinical samples were tested within the scope of the clinical study. In this
data set, 52 samples were found positive and 90 negative for Norovirus. All samples
were tested with the reference tests from Seegene (Allplex™ GI-Virus Assay) and
Vivalytic to determine the clinical performance for Vivalytic Norovirus. Discrepant
result was verified using RIDAGENE RIDA®GENE HSP (R-Biopharm) (1 sample).
Table 7 – Document History
Revision 01
Revision 02/03
Initial document
Pre-release changes
Vivalytic Norovirus
144
– Annex
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