BD Veritor System Bedienungsanleitung Seite 12

Analytical Studies
Analytical Sensitivity (Limit of Detection)
The limit of detection for Streptococcus pyogenes was established with the BD Veritor System for Rapid Detection of Group
A Strep test. The limit of detection (LOD) is defined as the lowest concentration that produces an approximate 95% positive
reaction when tested with 60 replicates.
Analytical Specificity (Cross Reactivity)
The reactivity of various Streptococcal strains was determined with the BD Veritor System for Rapid Detection of Group A
Strep test. Lancefield Groups B, C, D, F and G were tested at 1 X 10
Various microorganisms (including bacteria and yeasts) that might be found in specimens were evaluated for potential
cross reactivity with the BD Veritor System for Rapid Detection of Group A Strep test. Of the microorganisms tested, none
demonstrated cross-reactivity with the BD Veritor System for Rapid Detection of Group A Strep test.
Microorganism Name
Arcanobacterium haemolyticum
Bordetella pertussis
Candida albicans
Corynebacterium diphtherium sp.
(Corynebacterium sp.)
Enterococcus faecalis
Enterococcus faecium
Escherichia coli
Fusobacterium necrophorum
Haemophilus influenzae
Haemophilus parahaemolyticus
Clinical Performance Data – By Site
Site Code BD Veritor
Sensitivity: 100% (95% CI: 84.5%, 100%)
Specificity: 92.5% (95% CI: 86.4%, 96.0%)
POC 3 P
N
Total
Sensitivity: 100% (95% CI: 84.5%, 100%)
Specificity: 93.8% (95% CI: 87.8%, 97.0%)
P
POC 4
N
Total
Sensitivity: 100% (95% CI: 87.9%, 100%)
Specificity: 94.2% (95% CI: 89.1%, 97.1%)
LOD
Strain
(CFU/mL)
12384 1 x 10 5
19615 5 x 10 4
25663 2 x 10 5
Concentration
Tested
1 x 10 9 CFU/mL
5 x 10 8 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1.5 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1.2 x 10 5 CFU/mL
Culture
P
Reference Method: Culture
21
0
21
Reference Method: Culture
28
0
28
Reference Method: Culture
Results
57/60 Positive
58/60 Positive
57/60 Positive
9 CFU/mL in triplicate and yielded negative results.
Microorganism Name
Staphylococcus haemolyticus
Staphylococcus oralis
Staphylococcus sanguis
Streptococcus anginosus
Streptococcus mitis
Streptococcus mutans ATCC 25173
Streptococcus pneumoniae
Streptococcus salivarius
Streptococcus sp. Group B
Streptococcus sp. Group C
12
Total
N
7
28
106
106
113 134
8
36
131 131
139 167
% Positivity
95.0%
96.7%
95.0%
Concentration
Tested
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
3 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL
1 x 10 9 CFU/mL