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Vivalytic SARS-CoV-2 DT, Flu A/B, RSV
Limitations
The results of the Vivalytic SARS-CoV-2 DT, FluA/B, RSV test must be inter-
preted by a trained healthcare professional only. The results of the Vivalytic
SARS-CoV-2 DT, FluA/B, RSV test must not be used as the sole parameter for
diagnosis.
• A negative result does not exclude pathogens being present in the sample
at a level below assay sensitivity or a pathogen that is not covered by this
assay.
• There is a risk of false negative or false positive results due to improperly
collected, transported, or handled samples.
• In borderline cases atypical PCR characteristics (e. g. flat curve with low
or high C
-value) can occur. In case of atypical characteristics results are
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not allowed to be used for diagnostic interpretation. Inconclusive results
are marked by the software (). Retesting is advised.
• A positive result does not necessarily mean that viable viral particles are
present.
• Vivalytic SARS-CoV-2 DT, Flu A/B, RSV is a qualitative real-time PCR test
and does not provide a quantitative result.
Analytical Performance evaluation
Sensitivity (Limit of Detection, 95 % Detection rate)
The limit of detection of the Vivalytic SARS-CoV-2 DT, Flu A/B, RSV test was
determined as the concentration at which 95 % of the testing is expected to
yield a positive result using a hit rate approach (Flu A, Flu B and RSV) or a
Probit approach (SARS-CoV-2) (Table 1).
Inclusivity and Exclusivity
Specificity was ensured by the selection of primers and probes and their
in-silico analysis for possible cross-reactions based on publicly available nu-
cleic acid sequences derived from the NCBI database.
To evaluate inclusivity, reference material of several virus strains was tested
with Vivalytic SARS-CoV-2 DT, Flu A/B, RSV cartridges (Table 2).
To exclude cross-reactivity (exclusivity), an in-silico analysis (BLAST align-
ment) of the target regions was conducted against the genomic sequences
of various other pathogens representing common respiratory pathogens or
closely related species. Additionally, various respiratory organisms were
tested with Vivalytic SARS-CoV-2 DT, Flu A/B, RSV cartridges. There was no
evidence of an interference (Table 3).
Precision
The reproducibility and repeatability of the Vivalytic SARS-CoV-2 DT, Flu A/B,
RSV test for SARS-CoV-2 was established using a panel with 3 different con-
centrations. At 3 test sites, each mix was tested on the same set of Vivalytic
one analysers by the same operator in 2 replicates on 2 days, respectively.
Vivalytic cartridges were drawn from 3 LOTs and distributed in the overall
testing setup yielding in a total of 324 observations per target pathogen.
The obtained positivity rates for the different combinations were correlated to
the expected positivity rates (Table 4).
The reproducibility and repeatability of the Vivalytic SARS-CoV-2 DT, Flu A/B,
RSV test for Flu A/B and RSV was performed at one test site with a total of 4
mixes tested on the same set of Vivalytic one analysers by the same operator
in 2 replicates on 3 days with 3 different LOTs. The obtained positivity rates
for the different combinations were correlated to the expected positivity rates
(Table 5).
Interferences
Interferences were evaluated for endogenous and exogenous substances
that are potentially present in the patient sample. There was no evidence of
an interference (Table 6).
– Instructions for use
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