Idiomas disponibles
Idiomas disponibles
Table 12.
Drug
Clinical
Ampicillin
Amoxicillin/Clavulanate
Ampicillin/Sulbactam
Chloramphenicol
Cefaclor
Cefepime
Cefexime
Ceftriaxone
Cefuroxime (sodium)
Tetracycline
Clarithromycin
Imipenem
Meropenem
Trimethoprim/
Sulfamethoxazole
*
Studies with H. influenzae were conducted at 2 external and one internal site. Forty-six H. influenzae isolates, which were originally tested at one of the external sites (Site 3), showed
unacceptable major error rates (i.e. 3.6 to 19%) and very major error rates (i.e. 17.5 to 100%) with the use of the Vizion™ system for the following drugs: Ampicillin, Chloramphenicol,
Cefaclor, Ceftriaxone, Tetracycline, Clarithromycin, Imipenem, Meropenem, and TMP/SMX. This was attributed to site-specific issues of failure to follow on-site training along with
failure to confirm the Vizion™ system readings on a mirror viewer. These 46 isolates were later sent to another external laboratory (Site 4) for retesting using the Vizion™ system. Site 4
tested the same 46 clinical isolates as Site 3 as per the Technical Information (TI). The results presented in this Table (14) reflect the overall results from sites 1, 2 and 4. Please refer to
the limitations section.
Sensititre AIM™ Instructions for Use
Vizion™ system read Sites 1, 2, 4*
Total
Challenge
Total
evaluable
146
49
195
85
146
49
195
28
146
49
195
29
146
49
195
46
146
49
195
29
146
49
195
11
146
49
195
8
146
49
195
5
146
49
195
99
146
49
195
184
146
49
195
181
146
49
195
30
146
49
195
24
146
49
195
100
% EA
% EA of
Total
evaluable
%CA
100
100
98.9
99.5
100
99.5
100
100
99.5
100
100
99.5
100
100
97.5
100
100
100
100
100
100
100
100
100
100
100
100
99.5
100
100
100
100
96.9
100
100
100
100
100
100
100
100
99.5
Very
S
I
#R or NS
major
123
9
63
0
165
3
27
0
165
0
30
0
184
2
9
0
175
6
14
0
183
0
12
0
184
0
11
0
186
0
9
0
184
2
9
0
192
0
3
0
122
61
12
0
186
0
9
0
182
0
13
0
133
18
44
0
Major
Minor
0
2
0
1
1
0
0
1
0
5
0
0
0
0
0
0
0
0
0
0
0
6
0
0
0
0
0
1
47
