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Vivalytic SARS-CoV-2 DT, Flu A/B, RSV
Clinical Performance evaluation
Sensitivity and Specificity
The clinical performance of the Vivalytic SARS-CoV-2 DT, Flu A/B, RSV test
was assessed in a retrospective clinical study with nasopharyngeal, oro-
pharyngeal, and lolly-saliva swab samples in eNAT® medium (COPAN Italia
S.P.A.). Sensitivity or Positive Percent Agreement (PPA) was calculated as
100 % x TP/ (TP+FN). Specificity or Negative Percent Agreement was calcu-
ated as 100 % x TN / (TN+FP).
For SARS-CoV-2 sensitivity and specificity results derived from oropharyn-
geal and nasopharyngeal samples (positive and negative samples in eNAT®,
COPAN Italia S.P.A.) and lolly-saliva swabs (negative samples in eNAT®).
Samples were collected in a clinical setting and compared with those of a
reference method (Table 7). In total, 666 samples were analysed. Different
matrix types (nasopharyngeal, oropharyngeal and lolly-saliva) were shown
to be equivalent.
For FluA, FluB, and RSV sensitivity and specificity results derived from oro-
pharyngel, nasopharyngeal and lolly-swab samples (positive and negative
samples in eNAT®, COPAN Italia S.P.A) tested with two different reference
methods. In total, 617 samples were analysed. The results of the clinical
performance evaluation are shown in Table 8.
Symbols
Manufacturer
Date of manufacture
Expiry date
Lot number
Reference number
Contains <n> tests
CE mark
– Instructions for use
Serial number
Temperature limit
Do not use if package is damaged
For single use only
Consult Instructions for Use
in vitro diagnostic medical device
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