Vitek AST-GN75 User manual

bioMérieux SA English - 1
413 432 9310655-P1EN1 - 2015/08
AST-GN75
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.
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.
CONTENTS OF THE CARD
Antimicrobic Code Concentration § Calling Range
≤≥FDA Indications for Use
Amikacin AN 8, 16, 64 2 64 CSAGNB**
Ampicillin AM 4, 8, 32 2 32 CSAGNB**
Ampicillin/Sulbactam SAM 4/2, 16/8, 32/16 2/1 32/16 CSAGNB**
Cefazolin CZ 4, 16, 64 4 64 CSAGNB**
Cefepime FEP 2, 8, 16, 32 1 64 CSAGNB**
Cefoxitin FOX 8, 16, 32 4 64 CSAGNB**
Ceftazidime CAZ 1, 2, 8, 32 1 64 CSAGNB**
Ceftriaxone CRO 1, 2, 8, 32 1 64 CSAGNB**
Ciprofloxacin CIP 0.5, 2, 4 0.25 4 CSAGNB**
Ertapenem cETP 0.5, 1, 6 0.5 8 E. coli, K. pneumoniae, C. freundii,
C. koseri, E. aerogenes, E. cloacae,
Kox(-ESBL)**, M. morganii, P. mirabilis,
P. vulgaris, S. marcescens
ESBL , ESB
FEP 1, CTX 0.5, CAZ
0.5, FEP/CA 1/10,
CTX/CA 0.5/4, CAZ/CA
0.5/4
NEG POS E. coli, K. pneumoniae, K. oxytoca
Gentamicin GM 4, 16, 32 1 16 CSAGNB**
Levofloxacin LEV!0.25, 0.5, 2, 8 0.12 8 E. cloacae, E. coli, K. pneumoniae,
P. mirabilis, P. aeruginosa,
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
Meropenem MEM! 0.5, 2, 6, 12 0.25 16 E. coli, K. pneumoniae, P. aeruginosa,
P. mirabilis, Acinetobacter spp.,
C. freundii, E. cloacae, K. oxytoca,
M. morganii, P. vulgaris, S. marcescens,
A. hydrophila, C. diversus, H. alvei,
P. multocida, Salmonella spp.,
Shigella spp.
Nitrofurantoin FT 16, 32, 64 16 512 CSAGNB**

VITEK® 2 AST-GN75 9310655-P1EN1 - 2015/08
bioMérieux SA English - 2
Piperacillin PIP!4, 16, 32, 64 4 128 Acinetobacter spp., Enterobacter spp.,
E. coli, Klebsiella spp., M. morganii,
Pv. rettgeri, P. mirabilis, P. vulgaris,
P. aeruginosa, Serratia spp., B. cepacia,
C. koseri, C. freundii, P. fluorescens,
C. sakazakii
Tobramycin TM 8, 16, 64 1 16 CSAGNB**
Trimethoprim/Sulfamethoxazole SXT!1/19, 4/76, 16/304 20(1/19) 320(16/304) Klebsiella spp., Enterobacter spp.,
M. morganii, P. vulgaris, P. mirabilis,
S. sonnei, S. flexneri, Eco(+ETEC)**,
C. sakazakii
Numerical values are expressed in µg/ml.
§ Equivalent standard method concentration by efficacy.
**CSAGNB = Clinically significant aerobic gram negative bacilli
c= Category agreement was established at the time of FDA clearance. Essential agreement was not established since
test contains less than five discrete dilutions.
**Kox(-ESBL) = K. oxytoca (excluding ESBL producing strains)
Note: For ESBL, FEP is Cefepime, CTX is Cefotaxime, CAZ is Ceftazidime and CA is Clavulanic Acid. For ESBL positive
strains, the test interpretation should be reported as resistant for all penicillins, cephalosporins, and aztreonam.
NEG = Negative
POS = Positive
A negative ESBL test result does not rule out the presence of an ESBL masked by an AmpC beta-lactamase.
",!etc. = See performance characteristics identified by the drug code with this symbol in the Comment column in
Systems Product Information.
**Eco(+ETEC) = E. coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea)
QUALITY CONTROL
CLSI®Quality Control Organisms VITEK 2 Results
Antimicrobic Code
E. coli
ATCC® 25922™ P. aeruginosa ATCC® 27853™ E. coli ATCC® 35218™ K. pneumoniae ssp pneumoniae ATCC® 700603™
Amikacin AN ≤2 – 4 ≤2 – 4 - -
Ampicillin AM ≤2 – 8 - - -
Ampicillin/Sulbactam SAM ≤2/1 – 8/4 - 8/4 – ≥32/16 -
Cefazolin CZ ≤4 - - -
Cefepime FEP ≤1 ≤1 – 8 - -
Cefoxitin FOX ≤4 – 8 - - -
Ceftazidime CAZ ≤1 ≤1 – 4 - -
Ceftriaxone CRO ≤1 8 – ≥64 - -
Ciprofloxacin CIP ≤0.25 ≤0.25 – 1 - -
Ertapenem
c
ETP ≤0.5 2 – ≥8 - -
ESBL
,
ESB NEG - - POS
Gentamicin GM ≤1 ≤1 – 2 - -
Levofloxacin LEV ≤0.12 0.5 – 4 - -
Meropenem MEM ≤0.25 ≤0.25 – 1 - -
Nitrofurantoin FT ≤16 - - -
Piperacillin PIP ≤4 ≤4 – 8 - -
Tobramycin TM ≤1 ≤1 - -
Trimethoprim/Sulfamethoxazole SXT ≤20(1/19) 160(8/152) – ≥320(16/304) - -
Numerical values are expressed in µg/ml.
c= Category agreement was established at the time of FDA clearance. Essential agreement was not established since
test contains less than five discrete dilutions.
Note: For ESBL, FEP is Cefepime, CTX is Cefotaxime, CAZ is Ceftazidime and CA is Clavulanic Acid. For ESBL positive
strains, the test interpretation should be reported as resistant for all penicillins, cephalosporins, and aztreonam.
NEG = Negative
POS = Positive
A negative ESBL test result does not rule out the presence of an ESBL masked by an AmpC beta-lactamase.

VITEK® 2 AST-GN75 9310655-P1EN1 - 2015/08
bioMérieux SA English - 3
LIMITATIONS
Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combination(s):
• Amikacin: Acinetobacter baumannii
• Ampicillin: Citrobacter spp., Enterobacter spp., Pantoea spp., Serratia spp., Cronobacter sakazakii
• Ampicillin/Sulbactam: Citrobacter spp., Enterobacter spp., Pantoea spp., Serratia spp., Cronobacter sakazakii
Perform an alternative method of testing prior to reporting results when a resistant result is obtained with the following
antibiotic/organism combination(s):
• Meropenem: Aeromonas spp.
The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains
were not available at the time of comparative testing:
• Ertapenem: E. coli, K. pneumoniae, C. freundii, C. koseri, E. aerogenes, E. cloacae, K. oxytoca (excluding ESBL
producing strains), M. morganii, P. mirabilis, P. vulgaris, S. marcescens
NOTE: A result for an antibiotic/organism combination which may have a limitation may be suppressed from reporting.
Refer to the software user manual for instructions.

VITEK® 2 AST-GN75 9310655-P1EN1 - 2015/08
BIOMERIEUX, the blue logo, VITEK and bioLiaison are used, pending and/or registered trademarks belonging to bioMérieux SA or
one of its subsidiaries, or one of its companies. The ATCC trademark and trade name and any and all ATCC catalog numbers are
trademarks of the American Type Culture Collection. Any other name or trademark is the property of its respective owner.
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Durham, North Carolina
27712 USA
bioMérieux SA
Chemin de l’Orme
RCS LYON 673 620 399
69280 Marcy-l'Etoile / France
Tel. [phone]
Fax [phone]
www.biomerieux.com
#
#
MUST enter the following barcodes into “Flex
Panel Entry” program before first use of this
Susceptibility Card.
01 #A310G30J---H#
A310G30J---H
02 #BAST-GN75013#
BAST-GN75013
03 #C--01020O0EQ#
C--01020O0EQ
04 #D1C0K0G0H0LI#
D1C0K0G0H0LI
05 #E1N11031W2GF#
E1N11031W2GF
06 #F0Y20052300I#
F0Y20052300I
INDEX OF SYMBOLS
Symbol Meaning
Catalogue number
In Vitro Diagnostic Medical Device
Manufacturer
Date of Manufacture
Temperature limitation
Use by
Batch code
Consult Instructions for Use
Contains sufficient for <n> tests
Authorized representative in the
European Community
PATENTS
Product covered by one or more of U.S. Patent Nos.
D414,272; D437,797; 5,609,828; 5,746,980; 5,804,437;
5,869,005; 5,932,177; 5,951,952; 6,267,929; 6,309,890
and 6,340,573; and Foreign Counterparts. Other
Patents Pending.
WARRANTY
bioMérieux disclaims all warranties, express or implied,
including any implied warranties of MERCHANTABILITY
AND FITNESS FOR A PARTICULAR USE. bioMérieux
shall not be liable for any incidental or consequential
damages. IN NO EVENT SHALL BIOMERIEUX’S
LIABLITY TO CUSTOMER UNDER ANY CLAIM EXCEED
A REFUND OF THE AMOUNT PAID TO BIOMERIEUX
FOR THE PRODUCT OR SERVICE WHICH IS THE
SUBJECT OF THE CLAIM.