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Vivalytic Norovirus
– Instructions for Use
Inclusivity
To evaluate inclusivity, an in silico analysis (BLAST alignment) of the genomic
sequence of various relevant Noroviruses against the sequence of the PCR
primers and hydrolysis probe used in the Vivalytic Norovirus test for amplifi-
cation and detection of the respective pathogens was performed. Inclusivity
could be shown for strains listed in Table 2.
Exclusivity / Analytical Specificity
To exclude cross-reactivity (exclusivity), an in silico analysis (BLAST alignment)
of the target region of Norovirus against the genomic sequence of various other
pathogens representing common gastrointestinal pathogens or closely related
species was conducted. There was no evidence of an interference (Table 3).
Reproducibilty
The reproducibility of the Vivalytic Norovirus test was established using a
panel with 3 different concentrations of Norovirus. At 3 test sites, each mix
was tested on the same set of Vivalytic instruments by the same operator with
3 LOTs in 4 replicates on 3 days, respectively.. The obtained positivity rates
for the different combinations were correlated to the expected positivity rate
(Table 4a).
Repeatability
The repeatability of the Vivalytic Norovirus test was established using a panel
with 1 concentration (3x c95) of Norovirus. At 1 test site, the mix was tested
on the same set of Vivalytic instruments by the same operator with 3 LOTs in
20 replicates, respectively, yielding in a total of 60 observations per target
pathogen. The obtained positivity rates for the different combinations were
correlated to the expected positivity rate (Table 4b).
Interferences
Interferences were evaluated for endogenous and exogenous substances,
that are potentially present in the patient sample. Refer to Table 5 for sub-
stances that have the potential to interfere with the test.
Clinical Performance Evaluation
Sensitivity and specificity results derived from native liquid and soft human
stool samples. Samples were collected in a clinical setting and compared
with results of reference methods.
Samples for testing with Vivalytic Norovirus cartridges were freshly used or
frozen for storage and prepared as describe above in eNAT® (COPAN Italia
S.p.A.).
In case of reference testing samples were prepared according to recommen-
dations of used reference methods. In total, 124 samples were analysed.
Sensitivity or Positive Percent Agreement (PPA) was calculated as 100 % x
TP/ (TP+FN). Specificity or Negative Percent Agreement was calculated as
100 % x TN / (TN+FP). The results of the clinical performance evaluation are
shown in Table 6.
Technical Support
If you require any support, technical help or have additional questions, please
contact your local distributor or visit the Bosch Vivalytic website at
www.bosch-vivalytic.com.
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