Enterobacteriaceae
Non-Enterobacteriaceae
Pseudomonas aeruginosa
Acinetobacter baumannii
Summary of reproducibility data
The reproducibility of MIC tests at 3 trial sites was measured against 25 Gram-negative isolates.
Testing was performed using Sensititre™ plates read on the Vizion™ system, and AutoReader™ system.
Reproducibility was calculated as occurrences of the difference in number of wells between the test result
and test modal value. 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.
Please refer to Table 3 for summary.
Table 3. Gram-negative reproducibility of AIM system vs. AutoInoculator™ system
AutoReader™ system
Vizion™ system
*Off-scale isolates were used due to unavailability or insufficient number of isolates with on-scale MIC values for some
drug/organism combinations.
Even though the MIC values were off scale for a large number of isolates, which has resulted in low
performance based on "worst-case" calculation, the overall reproducibility was considered acceptable,
since very high essential agreement was observed based on "best-case" calculation and when
calculations were made using on-scale MIC values only.
Sensititre AIM™ Instructions for Use
161
22
27
12
% Reproducibility (AIM system vs. AutoInoculator™ system)
Best case
(Assuming off-scale result
is within one well from the
mode)
99.5
99.6
99.9
99.3
100
100
On scale
(On-scale values
(Assuming off-scale result is
only)
greater than one well from
99.7
99.8
98.4
98.7
100
98.8
Worst case*
the mode)
71.2
74.4
37