Idiomas disponibles
Idiomas disponibles
Table 13. A combination of all MIC/SIR values for all Candida spp. per antifungal using the mirror
read
Organisms
Candida spp.
*Only C. albicans isolates were included in accordance with the FDA approved Itraconazole drug label.
Table 14. Clinical and challenge isolate results summary for the AIM system vs. existing
AutoInoculator™ system for Cefoxitin Screen Test and D Test: AutoReader™/Vizion™ systems
reads
Cefoxitin Screen
S. aureus
AutoReader™ system
Vizion™ system
D Test S.
aureus
AutoReader™ system
Vizion™ system
D Test
Coagulase negative
staphylococci
AutoReader™ system
Vizion™ system
Summary of reproducibility data
The reproducibility of MIC tests at 3 trial sites was measured against:
25 Gram-positive isolates
25 Streptococcus spp. 25
Haemophilus influenzae
25 Candida spp.
Testing was performed using Sensititre™ plates read on the Vizion™ system, AutoReader™ system, and
mirror. Reproducibility was calculated as occurrences of the difference in number of wells between the
test result and test mode. Percentages of results were calculated for the combined sites plus or minus
one dilution of the modal value (best and worst case scenarios assuming the off scale result is within one
well from the mode and assuming the off-scale result is greater than one well from the mode) for all sites.
The MIC values were off-scale for a large number of isolates, which has resulted in low performance
based on "worst-case" calculations, the overall reproducibility was considered acceptable, since very high
48
Overall % MIC/SIR comparative agreement with the AIM system
Flucytosine
(5-FC)
Itraconazole*
100/99.3
100/98.3
Total
#CA
%CA
89
86
96.6
88
87
98.9
Total
#CA
%CA
89
87
97.8
88
87
98.9
Total
# CA
% CA
61
61
100.0
61
61
100.0
Fluconazole
100/99.3
#R
#VMJ
%VMJ
41
1
2.4
42
0
0.0
#R
#VMJ
%VMJ
42
1
2.4
42
1
2.4
#R
# VMJ
%VMJ
30
0
0.0
30
0
0.0
Sensititre AIM™ Instructions for Use
Voriconazole
99.7/99.7
#S
#MAJ
%MAJ
48
2
4.2
46
1
2.2
#S
#MAJ
%MAJ
47
1
2.1
46
0
0.0
#S
#MAJ
%MAJ
31
0
0.0
31
0
0.0
