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421 982
Gram Negative Susceptibility Card
SUMMARY AND EXPLANATION
®
The VITEK
2 Gram Negative Susceptibility Card is
intended for use with the VITEK 2 Systems in clinical
laboratories as an in vitro test to determine the
susceptibility of clinically significant aerobic gram-
negative bacilli to antimicrobial agents when used as
instructed in the Product Information manual.
CONTENTS OF THE CARD
Antimicrobic
Ampicillin
Ampicillin/Sulbactam
Cefazolin
Cefepime
Ceftazidime
Ceftriaxone
Ciprofloxacin
Ertapenem
ESBL
Gentamicin
Imipenem
Levofloxacin
Nitrofurantoin
AST-GN95
Code
Concentration §
AM
4, 8, 32
SAM
4/2, 16/8, 32/16
CZ
4, 16, 64
FEP
0.25, 1, 4, 16, 32
CAZ
1, 2, 8, 32
CRO
0.12, 0.25, 1, 4, 16
CIP
0.5, 2, 4
ETP
0.03, 0.12, 0.5, 2
ESB
FEP 1, CTX 0.5, CAZ
0.5, FEP/CA 1/10,
CTX/CA 0.5/4, CAZ/CA
0.5/4
GM
4, 16, 32
IPM
1, 2, 6, 12
LEV! 0.25, 0.5, 2, 8
FT
16, 32, 64
bioMérieux SA
INSTRUCTIONS FOR USE
A package insert is provided in the kit or downloadable
from www.biomerieux.com/techlib
See the Product Information manual for additional
Instructions for Use.
STORAGE CONDITIONS
Store at 2° to 8° C.
Calling Range
≤
≥
2
32
2/1
32/16
4
64
0.12
32
P. aeruginosa, C. koseri, C. freundii,
P. agglomerans, K. oxytoca, P. vulgaris,
Pv. rettgeri, Pv. stuartii, S. marcescens
1
64
0.25
64
E. aerogenes, E. coli, K. oxytoca,
S. marcescens, C. koseri, C. freundii,
Shigella spp., PROV(+Pv.rettgeri)**,
0.25
4
0.12
8
E. coli, K. pneumoniae, C. freundii,
C. koseri, E. aerogenes, E. cloacae,
Kox(-ESBL)**, M. morganii, P. mirabilis,
P. vulgaris, Pv. rettgeri, Pv. stuartii,
NEG
POS
E. coli, K. pneumoniae, K. oxytoca
1
16
0.25
16
Acinetobacter spp., Citrobacter spp.,
Klebsiella spp., M. morganii, P. vulgaris,
0.12
8
E. cloacae, E. coli, K. pneumoniae,
S. marcescens, A. baumannii, A. lwoffii,
C. koseri, C. freundii, E. aerogenes,
E. sakazakii, K. oxytoca, M. morganii,
P. agglomerans, P. vulgaris, Pv. rettgeri,
Pv. stuartii, P. fluorescens, C. sakazakii
16
512
English - 1
9313430 - 2017/11
FDA Indications for Use
CSAGNB**
CSAGNB**
CSAGNB**
Enterobacter spp., E. coli,
K. pneumoniae, P. mirabilis,
CSAGNB**
K. pneumoniae, P. mirabilis,
SAL(+S.typhi)**
CSAGNB**
S. marcescens
CSAGNB**
Enterobacter spp., E. coli,
Pv. rettgeri, P. aeruginosa,
S. marcescens, Pv. stuartii
P. mirabilis, P. aeruginosa,
CSAGNB**
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Summary of Contents for bioMérieux VITEK 2 AST-GN95
- Page 1 421 982 9313430 - 2017/11 AST-GN95 Gram Negative Susceptibility Card SUMMARY AND EXPLANATION INSTRUCTIONS FOR USE ® The VITEK 2 Gram Negative Susceptibility Card is A package insert is provided in the kit or downloadable intended for use with the VITEK 2 Systems in clinical from www.biomerieux.com/techlib laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram-...
- Page 2 ® VITEK 2 AST-GN95 9313430 2017/11 Antimicrobic Code Concentration § Calling Range FDA Indications for Use ≤ ≥ Piperacillin/Tazobactam 128/4 2/4, 8/4, 24/4, 32/4, A. baumannii, E. coli, K. pneumoniae, 32/8, 48/8 P. aeruginosa, C. koseri, M. morganii, P. mirabilis, P. vulgaris, Pv. rettgeri, Pv.
-
Page 3: Quality Control
® VITEK 2 AST-GN95 9313430 2017/11 QUALITY CONTROL ® CLSI Quality Control Organisms VITEK 2 Results Antimicrobic Code E. coli P. aeruginosa E. coli K. pneumoniae ssp ATCC® 25922™ ATCC® 27853™ ATCC® 35218™ pneumoniae ATCC® 700603™ ≤2 – 8 Ampicillin ≤2/1 –... - Page 4 ® VITEK 2 AST-GN95 9313430 2017/11 Although within Essential Agreement, the lack of an intermediate category has shown major and very major discrepancies when compared to the reference method. Testing should be repeated using an alternative testing/reference method prior to reporting results when the VITEK 2 MIC is 8 µg/ml or 16 µg/ml for the following antibiotic/organism(s): •...
- Page 5 ® VITEK 2 AST-GN95 9313430 2017/11 INDEX OF SYMBOLS MUST enter the following barcodes into “Flex Panel Entry” program before first use of this Symbol Meaning Susceptibility Card. #A310IJ0I---4# Catalogue number A 3 1 0 I J 0 I - - - 4 In Vitro Diagnostic Medical Device #BAST-GN9501J# Manufacturer...
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