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

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.

bioMérieux, Inc.

100 Rodolphe Street

Durham, North Carolina

27712 USA

bioMérieux SA

Chemin de l’Orme

RCS LYON 673 620 399

69280 Marcy-l'Etoile / France

Tel. 33 (0)4 78 87 20 00

Fax 33 (0)4 78 87 20 90

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.

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