Thermo Scientific Sensititre AIM Instrucciones De Uso página 36

Appendix A. Performance
characteristics of the AIM system with
Gram-negative isolates
Performance of the AIM system was evaluated at 3 sites against a previous version of the device
(Thermo Scientific Sensititre AutoInoculator™ System) and the susceptibility results compared. Testing
involved a wide variety of clinical and challenge isolates, including some with current resistance patterns.
The following clinical and challenge isolates were tested:
Escherichia coli
Pseudomonas aeruginosa
Acinetobacter spp.
Klebsiella spp.
Proteus spp.
Citrobacter spp.
Enterobacter spp.
Serratia spp.
The performance characteristics are shown in the tables below. Each table header below contains the
interpretative MIC standards used for the data analysis. Interpretations conform to those stated by the
FDA.
The overall essential agreement rates (±1 log
from the AutoInoculator system) for the data sets representing the non-fastidious Gram-negative isolates
were 99.8% for the AutoReader™ system, and 99.8% for the Vizion™ system.
The overall categorical agreement (S, I, R), according to the FDA MIC interpretive categories comparing
results from the AIM system to those from the existing AutoInoculator™ system, was 98.7% for the
AutoReader™ system, and 99.4% for the Vizion™ system. See Tables 1 and 2 below:
Table 1. Clinical and challenge isolate AutoReader system results for the AIM system vs.
AutoInoculator™ system
Organism
Enterobacteriaceae
Non-Enterobacteriaceae
Pseudomonas aeruginosa
Acinetobacter baumannii
Table 2. Clinical and challenge isolate Vizion™ system read results for the AIM system vs.
AutoInoculator™ system
Organism
Sensititre AIM™ Instructions for Use
40
27
19
30
17
10
24
20
dilution of results from the AIM system compared to those
2
Total isolates tested
161
22
27
12
Total isolates tested
Burkholderia cepacia
Morganella morganii
Providencia spp.
Pseudomonas spp.
Stenotrophomonas maltophilia
Aeromonas hydrophila
% Essential agreement
99.8
99.3
100
100
% Essential agreement
1
8
10
13
1
2
% Categorical
agreement
98.7
97.4
100
97.6
% Categorical
agreement
36