Idiomas disponibles
Idiomas disponibles
Percent growth rate
The percent growth rate for this study of 1017 clinical and challenge isolates was 99.4%, with a no growth
rate of 0.55%.
Performance characteristics (clinical and challenge data)
The AIM system was validated in the following manner:
A wide variety of clinical and challenge isolates, including some with current resistance patterns, were
tested using the AIM system to compare its performance to the AutoInoculator™ system.
The results for the data sets representing the non-fastidious Gram-positive, fastidious H. influenzae and
S. pneumoniae, and yeast isolates for the overall essential agreement rate (±1 log
AIM system compared to the AutoInoculator™ system) were 99.7% for the AutoReader™ system, 99.8%
for the Vizion™ system, and 99.9% for mirror reads (Candida). The overall categorical agreement
(qualitative (S, I, R)), according to the FDA MIC interpretive categories comparing the AIM system to the
AutoInoculator™ system, was 99.1% for the AutoReader™ system, 99.1% for the Vizion™ system, and
99.2% for mirror reads. See the tables below.
Table 4. Clinical and challenge isolate auto read results for the AIM system vs. AutoInoculator™
system
Organism
Staphylococcus aureus
Staphylococcus spp. (CNS)
Enterococcus spp.
Beta-hemolytic group (MHB)*
Streptococcus pneumoniae
Viridans Streptococcus spp.
Beta-hemolytic group
Streptococcus spp. (LHB)**
Overall
*Includes 6 challenge isolates of Streptococcus pyogenes and 5 challenge isolates of Streptococcus agalactiae tested in Mueller
Hinton Broth (MHB).
**Includes 67 Streptococcus pyogenes, 64 Streptococcus agalactiae, and 26 other beta hemolytic isolates tested with the addition
of Lysed Horse Blood (LHB).
Sensititre AIM™ Instructions for Use
Total isolates tested
89
61
56
11
84
72
157
530
% Essential agreement
99.8
99.4
100
100
99.2
99.8
99.7
99.7
dilution of the
2
% Categorical
agreement
99.4
99.5
98.2
100
97.7
99.1
99.8
99.1
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