BD Veritor System Bedienungsanleitung Seite 16

Table 7: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to
PCR for Nasal Swabs – Japan Sites
POC: BD Flu A P
P 37
N 2
Total 39
Reference Method: PCR
PPA: 94.9% (95% C.I: 83.1–98.6%)
NPA: 93.9% (95% C.I: 85.4–97.6%)
Reproducibility
The reproducibility of the BD Veritor System for Rapid Detection of Flu A+B test was evaluated at three POC sites. The
reproducibility panel was composed of 30 simulated influenza A or B 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 such that positive results occur ~5% of the time) and negative samples. The panel was tested by two operators at each
site for five consecutive days. The results are summarized below.
Reproducibility Results – Percent of Flu A Positives
Sample
High negative
H1N1 A (95% C.I: 0.0–11.3%)
Low positive
H1N1 A (95% C.I: 70.3–94.7%)
Moderate positive
H1N1 A (95% C.I: 88.6–100%)
High negative
H3N2 A (95% C.I: 0.0–11.3%)
Low positive
H3N2 A (95% C.I: 88.6–100%)
Moderate positive
H3N2 A (95% C.I: 88.6–100%)
Negatives
Reproducibility Results – Percent of Flu B Positives
Sample
High negative B
Low positive B
(95% C.I: 55.6–85.8%)
Moderate positive B
(95% C.I: 88.3–100%)
Negatives
Analytical Studies
Analytical Sensitivity (Limit of Detection)
The limit of detection (LOD) for the BD Veritor System for Rapid Detection of Flu A+B test was established for a total of
8 influenza strains: 5 influenza A and 3 influenza B. The LOD for each strain represents the lowest concentration producing a
positivity rate of ≥95% based on testing 20 to 60 replicates.
Type Influenza Viral Strain
A A/Brisbane/10/2007 H3N2
A A/Brisbane/59/2007 H1N1
A A/California/7/2009 H1N1
A A/Victoria/3/75 H3N2
A A/Anhui/1/2013 H7N9
B B/Brisbane/60/2008
B B/Florida/4/2006
B
TCID /mL = 50% Tissue Culture Infectious Dose
50
EID /mL= 50% Egg Infectious Dose
50
Reference PCR
N Total
4 41
62 64
66 105
Site 1
0.0% (0/30)
86.7% (26/30)
100% (30/30)
0.0% (0/30)
100% (30/30)
100% (30/30)
0.0% (0/119)
(95% C.I: 0.0–3.1%)
Site 1
0.0% (0/30)
(95% C.I: 0.0–11.3%)
73.3% (22/30)
100% (29/29)
0.0% (0/210)
(95% C.I: 0.0–1.8%)
B/Lee/40
POC: BD Flu B
P
N
Total
Reference Method: PCR
PPA: 83.9% (95% C.I: 67.4–92.9%)
NPA: 91.9% (95% C.I: 83.4–96.2%)
Site 2
10% (3/30)
(95% C.I: 3.5–25.6%)
96.7% (29/30)
(95% C.I: 83.3–99.4%)
100% (30/30)
(95% C.I: 88.6–100%)
10% (3/30)
(95% C.I: 3.5–25.6%)
93.3% (28/30)
(95% C.I: 78.7–98.2%)
100% (30/30)
(95% C.I: 88.6–100%)
0.8% (1/119)
(95% C.I: 0.1–4.6%)
Site 2
3.3% (1/30)
(95% C.I: 0.6–16.7%)
90% (27/30)
(95% C.I: 74.4–96.5%)
96.6% (28/29)
(95% C.I: 82.8–99.4%)
1.0% (2/210)
(95% C.I: 0.3–3.4%)
Calculated LOD Calculated LOD
(TCID /mL)
50
7.27 x 10 2
3.30 x 10 2
5.00 x 10 3
3.11 x 10
3
N/A
7.42 x 10
3
1.30 x 10 3
4.44 x 10
4
16
Reference PCR
P N
26 6
5 68
31 74
Site 3
26.7% (8/30)
(95% C.I: 14.2–44.4%)
100% (30/30)
(95% C.I: 88.6–100%)
100% (30/30)
(95% C.I: 88.6–100%)
16.7% (5/30)
(95% C.I: 7.3–33.6%)
96.7% (29/30)
(95% C.I: 83.3–99.4%)
100% (30/30)
(95% C.I: 88.6–100%)
0.0% (0/119)
(95% C.I: 0.0–3.1%)
Site 3
26.7% (8/30)
(95% C.I: 14.2–44.4%)
90% (27/30)
(95% C.I: 74.4–96.5%)
100% (29/29)
(95% C.I: 88.3–100%)
0.0% (0/210)
(95% C.I: 0.0–1.8%)
No. Positive /
(EID /mL) Total
50
N/A 57/60
N/A 57/60
N/A 57/60
N/A 59/60
5.42 x 10 6 59/60
N/A 58/60
N/A 58/60
N/A 20/20
Total
32
73
105
Total
12.2% (11/90)
(95% C.I: 7.0–20.6%)
94.4% (85/90)
(95% C.I: 87.6–97.6%)
100% (90/90)
(95% C.I: 95.9–100%)
8.9% (8/90)
(95% C.I: 4.6–16.6%)
96.7% (87/90)
(95% C.I: 90.7–98.9%)
100% (90/90)
(95% C.I: 95.9–100%)
0.3% (1/357)
(95% C.I: 0.0–1.6%)
Total
10% (9/90)
(95% C.I: 5.4–17.9%)
84.4% (76/90)
(95% C.I: 75.6–90.5%)
98.9% (86/87)
(95% C.I: 93.8–99.8%)
0.3% (2/630)
(95% C.I: 0.1–1.2%)
% Positive
95%
95%
95%
98.3%
98.3%
96.7%
96.7%
100%