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Table 7 – Clinical Sensitivity (PPA) and Specificity (NPA) for
SARS-CoV-2 samples in eNAT® (95 % confidence interval)
SARS-CoV-2
PPA 97.5 % (93.80 – 99.32 %)*
NPA 98.4 % (96.87 – 99.31 %)**
Clinical Performance data gained from 504 negative samples (442 oropharyngeal,
8 nasopharyngeal, 54 lolly-saliva) and 162 positive samples (93 oropharyngeal, 69
nasopharyngeal) in comparison to reference test system Vivalytic SARS-CoV-2 (Bosch
Healthcare Solutions) after discrepancy analysis.Retrospective study with in total 666 swab
samples tested at one study site. .
* 4 samples were tested as false negative
** 8 samples were reported as false positive
Table 8a – Clinical Sensitivity (PPA) and Specificity (NPA)
for Flu A, Flu B and RSV lolly-saliva samples in eNAT®
(95 % confidence interval)
Flu A
PPA 51.1 % (40.44– 61.66 %)*
NPA 99.6 % (97.85 – 99.99 %)**
Flu B
PPA 81.1 % (74.93 – 86.35 %)***
NPA 99.4 % (96.94 – 99.99 %)**
RSV A/B
PPA 84.1 % (72.74 – 92.12 %)****
NPA 100.0 % (98.83 – 100.00 %)
Clinical performance data of Vivalytic SARS-CoV-2 DT, Flu A/B, RSV in comparison to the
RIDA® GENE Flu & RSV (R-Biopharm AG). Retrospective clinical study with in total 427 valid
results for Flu A, Flu B, and RSV each, generated at one study site. For Flu A, Flu B and RSV,
all positive samples were created by spiking of negative patient swab samples in COPAN
eNAT® medium with respective reference material(viral cells) in different concentrations
between 1000-64000 copies/test. For Flu A H1N1 and H3N2 strains were used for spiking.
*
45 samples were tested as false negative.
**
1 sample were reported as false positive.
*** 37 samples were reported as false negative.
**** 10 samples were reported as false negative.
Table 8b – Clinical Sensitivity (PPA) and Specificity (NPA) for Flu A,
Flu B and RSV nasopharyngeal and oropharyngeal swab samples in
eNAT® (95 % confidence interval, retrospective clinical study)
Flu A
PPA 78.6 % (49.20 – 95.34 %)*
NPA 91.3 % (71.96 – 98.93 %)**
Flu B
PPA 100.0 % (54.07 – 100.00 %)
NPA 100.0% (88.78 – 100.00 %)
RSV A/B
PPA 47.1 % (22.98 – 72.19 %)***
NPA 100.0 % (83.16 – 100.00 %)
Clinical performance data of Vivalytic SARS-CoV-2 DT, Flu A/B, RSV in comparison to the
Allplex™ RV Essential Assay (Seegene). Retrospective clinical study with in total 37 valid
results for Flu A, Flu B, and RSV each, generated at one study site.
* 3 samples were tested as false negative.
** 2 samples were reported as false positive.
*** 9 samples were reported as false negative.
Vivalytic SARS-CoV-2 DT, Flu A/B, RSV
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