Thermo Scientific Sensititre AIM Instrucciones De Uso página 38

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Appendix B. Performance characteristics of the
AIM system for Gram-positive, Haemophilus
influenzae, Streptococcus pneumoniae, and
yeast isolates
Performance of the AIM system was evaluated at 3 sites against the AutoInoculator™ system:
The following plate formats were tested using the AIM system and the AutoInoculator™ system. The
susceptibility results were compared.
Gram-positive isolates:
Fastidious isolates:
Candida species:
The following clinical and challenge isolates were tested:
Quality control results
The CLSI recommended QC organisms listed below were tested at each clinical site. Please refer to
CLSI documents M100 and M60. Clinical trial results are reported for days on which QC results were in
QC range.
S. aureus
E. faecalis
S. pneumoniae
H. influenzae
C. parapsilosis
C. krusei
S. aureus
Data analysis
The performance characteristics are shown in the Tables 6-11. Interpretations conform to those stated by
the FDA.
Sensititre AIM™ Instructions for Use
CMT1DGPF
HPB and CMT1DSTF
YO2V
Staphylococcus aureus
Staphylococcus spp.
Enterococcus spp.
Beta hemolytic Streptococcus spp.
Streptococcus pneumoniae
Viridans Streptococcus spp.
Haemophilus influenzae
Candida spp.
ATCC® 29213™
ATCC® 29212™, ATCC® 51299™
ATCC® 49619™
ATCC® 49247™, ATCC® 49766™
ATCC® 22019™
ATCC® 6258™
ATCC® BAA-976™, ATCC® BAA-977™
89
61
56
157
84
72
195
303
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