BD Veritor System Handbuch Seite 12

Age Group
<2
2–5
Total
The table below summarizes the performance obtained with clinical specimens using the BD Veritor System RSV test in
comparison to a commercially available PCR. The overall positive percent agreement (PPA) and negative percent agreement
(NPA) of the BD Veritor System RSV with a PCR comparator, based on these 523 specimens, are 81.6% (146/179) and
99.1% (341/344), respectively.
BD Veritor RSV
P
N
Total
Reference Method: PCR
PPA: 81.6% (95% CI: 75.2%, 86.6%)
NPA: 99.1% (95% CI: 97.5%, 99.7%)
BD Veritor System RSV test performance compared to viral cell culture was also evaluated in this study. For the same
523 specimens 91.8% (123/134) were positive by both BD Veritor RSV and cultures, 93.3% (363/389) were negative by both
BD Veritor RSV and culture. There were 26 BD Veritor RSV positive, viral cell culture negative specimens of which 23 were
demonstrated to be RSV positive by an FDA cleared molecular assay.
Invalid rates for the BD Veritor System for Rapid Detection of RSV were calculated by dividing the number of invalids by the
total number of evaluable specimens tested by the BD Veritor System. The overall invalid rate for the BD Veritor System for
RSV based on the 523 specimens was determined to be 0.2% (1/523, 95% CI: 0.0%, 1.1%).
Reproducibility
The reproducibility of the BD Veritor System for Rapid Detection of RSV test was evaluated at two POC sites (P-1, P-2) and
one clinical laboratory site (S-1). The reproducibility panel was composed of 12 simulated RSV samples. These included
moderate positive samples, low positive samples (near the assay limit of detection), high negative samples (i.e., containing
very low concentrations of virus) and negative samples. The panel was tested by two operators at each site for five
consecutive days. The results are summarized below.
Sample
% Pos
High 6.7%
negative (2/30)
RSV
Low 90.0%
positive (27/30)
RSV
Moderate 100%
positive (30/30)
RSV
Negative 0.0%
(0/30)
Demographics Summary – Age Group
BD Veritor RSV Compared to PCR
P
146
33
179
BD Veritor RSV Reproducibility (% RSV Positive Results)
-
P 1
95% CI % Pos
1.8%, 21.3% 6.7%
(2/30)
74.4%, 96.5% 76.7%
(23/30)
88.6%, 100% 100%
(30/30)
0.0%, 11.3% 0.0%
(0/30)
Number
305
218
523
PCR
N
3
341
344
-
P 2
95% CI % Pos
1.8%, 21.3% 13.3%
(4/30)
59.1%, 88.2% 80.0%
(24/30)
88.6%, 100% 100%
(30/30)
0.0%, 11.3% 0.0%
(0/30)
12
Percentage
58.3
41.7
100
Total
149
374
523
-
S 1
95% CI % Pos
5.3%, 29.7% 8.9%
(8/90)
62.7%, 90.5% 82.2%
(74/90)
88.6%, 100% 100%
(90/90)
0.0%, 11.3% 0.0%
(0/90)
Total
95% CI
4.6%, 16.6%
73.1%, 88.8%
95.9%, 100%
0.0%, 4.1%