BD Veritor System Bedienungsanleitung Seite 15

Table 2: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to
PCR for All Swabs - U.S. Sites
POC: BD Flu A P
P 122
N 33*
Total 155
Reference Method: PCR
PPA: 78.7% (95% C.I: 71.6–84.4%)
NPA: 97.8% (95% C.I: 95.7–98.9%)
* Of the 33 PCR positive, BD Veritor negative Influenza A specimens, eight were positive in the BD Veritor assay using a second swab
specimen (reference method specimen) collected from the same patient.
** Of the 26 PCR positive, BD Veritor negative Influenza B specimens, six were positive in the BD Veritor assay using a second swab
specimen (reference method specimen) collected from the same patient.
Table 3: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to
PCR for Nasopharyngeal Swabs - U.S. Sites
POC: BD Flu A P
P 53
N 18
Total 71
Reference Method: PCR
PPA: 74.6% (95% C.I: 63.4–83.3%)
NPA: 96.4% (95% C.I: 91.9–98.5%)
Table 4: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to
PCR for Nasal Swabs – U.S. Sites
POC: BD Flu A P
P 69
N 15
Total 84
Reference Method: PCR
PPA: 82.1% (95% C.I: 72.6–88.9%)
NPA: 98.6% (95% C.I: 96.1–99.5%)
The performance of the BD Veritor System for Rapid Detection of Flu A+B test at the Japan sites were also compared to the
same FDA-cleared Influenza A and B molecular assay (PCR) and are presented in Table 5 through Table 7.
Table 5: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to
PCR for all Swabs - Japan Sites
POC: BD Flu A P
P 67
N 4
Total 71
Reference Method: PCR
PPA: 94.4% (95% C.I: 86.4–97.8%)
NPA: 96.7% (95% C.I: 92.4–98.6%)
Table 6: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to
PCR for all Nasopharyngeal Swabs - Japan Sites
POC: BD Flu A P
P 30
N 2
Total 32
Reference Method: PCR
PPA: 93.8% (95% C.I: 79.9–98.3%)
NPA: 98.8% (95% C.I: 93.6–99.8%)
Reference PCR
N Total
8 130
352 385
360 515
Reference PCR
N Total
5 58
135 153
140 211
Reference PCR
N Total
3 72
217 232
220 304
Reference PCR
N Total
5 72
145 149
150 221
Reference PCR
N Total
1 31
83 85
84 116
POC: BD Flu B
P
N
Total
Reference Method: PCR
PPA: 74.3% (95% C.I: 65–81.8%)
NPA: 99.5% (95% C.I: 98.3–99.9%)
POC: BD Flu B
P
N
Total
Reference Method: PCR
PPA: 73.3% (95% C.I: 55.6–85.8%)
NPA: 99.4% (95% C.I: 96.9–99.9%)
POC: BD Flu B
P
N
Total
Reference Method: PCR
PPA: 74.6% (95% C.I: 63.4–83.3%)
NPA: 99.6% (95% C.I: 97.6–99.9%)
POC: BD Flu B
P
N
Total
Reference Method: PCR
PPA: 91.4% (95% C.I: 82.5–96%)
NPA: 94.7% (95% C.I: 89.9–97.3%)
POC: BD Flu B
P
N
Total
Reference Method: PCR
PPA: 97.4% (95% C.I: 86.8–99.5%)
NPA: 97.4% (95% C.I: 91.0–99.3%)
15
Reference PCR
P N Total
75 2 77
26** 412 438
101 414 515
Reference PCR
P N Total
22 1 23
8 180 188
30 181 211
Reference PCR
P N Total
53 1 54
18 232 250
71 233 304
Reference PCR
P N Total
64 8 72
6 143 149
70 151 221
Reference PCR
P N Total
38 2 40
1 75 76
39 77 116