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Panel:   Enterobacterales Carbapenem Breakpoint (BIT)
AR Bank # 0010 Klebsiella pneumoniae
Study ID: BIT-10

Biosample Accession #: SAMN04014851

mCIM Result: Negative    
MLST: 461(Pasteur)

MICs obtained by broth microdilution. Modal MIC is reported.

MIC results for each antimicrobial agent for an isolate may commonly be ± 1 log2 (doubling dilution) different than what is posted on the FDA & CDC AR Bank website because this is the normal technical variability of antimicrobial susceptibility testing (see J. H. Jorgensen. 1993. J Clin Microbiol. Vol 31[11]: 2841-2844).

Panel:  Enterobacterales Carbapenem Breakpoint (BIT)  |  Piperacillin-tazobactam +aminoglycosides for Enterobacterales (PTA) (Custom)  |  PTA - BIT set only (Custom)


MIC (μg/ml) Results and Interpretation
Drug MIC (μg/ml) INT
Amikacin 8I
Ampicillin >32R
Ampicillin/sulbactam 1>32R
Aztreonam 32R
Cefazolin >8R
Cefepime 8SDD
Cefepime/zidebactam 21---
Cefotaxime 128R
Cefotaxime/clavulanic acid 1>64---
Cefoxitin >16R
Ceftazidime >128R
Ceftazidime/avibactam 12S
Ceftazidime/clavulanic acid 1>64---
Ceftolozane/tazobactam 116R
Ceftriaxone >32R
Ciprofloxacin <=0.25S
Colistin 51I
Doripenem 1S
Eravacycline 30.12S
Ertapenem >8R
Gentamicin 2S
Imipenem 4R
Imipenem/relebactam 10.5S
Imipenem+chelators 42---
Levofloxacin <=0.12S
Meropenem 1S
Meropenem-vaborbactam 1<=0.5S
Minocycline <=4S
Nitrofurantoin 128R
Piperacillin/tazobactam 164R
Plazomicin 2S
Tetracycline 4S
Tigecycline 31S
Tobramycin 4I
Trimethoprim/sulfamethoxazole 1<=0.5S
S – I –R Interpretation (INT) derived from CLSI 2023 M100 S33
1 Reflects MIC of first component
2 Cefepime to zidebactam ratio (1:1)
3 Based on FDA break points
4 Screen for metallo-beta-lactamase production [Rasheed et al. Emerging Infectious Diseases. 2013. 19(6):870-878]
5 Clinical and PK/PD data demonstrate colistin has limited clinical efficacy, even if an intermediate result is obtained. Alternative agents are strongly preferred. Colistin should be used in combination with one or more active antimicrobial agents. Consultation with an infectious disease specialist is recommended.
Device manufacturers and users of FDA cleared devices shall consult the FDA’s Antibacterial Susceptibility Test Interpretive Criteria       website for breakpoints recognized or recommended by FDA, and for information regarding FDA exceptions or additions to the applicable, recognized consensus standard.
Molecular Mechanisms of Resistance
CategoryGene
Beta-lactam CMY-94, SHV-1
Efflux pumps/Other EMRD, KDEA
Fosfomycin fosA
Quinolone oqxA, oqxB14
Truncated Porin Omp35, OmpK35
 
Disclaimer:
AR gene prediction was performed using ARG-ANNOT, ResFinder and NCBI (ResGANNCBI) databases accessed on 2021-05-07. AR drug classes are assigned according to these databases. This analysis does not include mutations that may result in antibiotic resistance or resistance determinants added to newer versions of used database or other antimicrobial resistance gene databases. For resistance determinant detection, 99-100% sequence identity and 100% sequence coverage from GAMMA and SRST2 was used. GAMMA uses amino acid sequence to assign gene alleles from assemblies; SRST2 uses nucleotide sequence to assign gene alleles from sequencing reads. Biosample accession numbers have been provided so that users can analyze the data on their own if so desired. *Presence of Efflux Pump may not be associated with resistance. *MLST Type (and scheme), as determined by Torsten Seemann's MLST program. For Enterobacterales, the Pasteur MLST schemes are used except for E. coli for which both the Pasteur and Achtman schemes are reported. SUB=novel MLST identified and "submitted".
Propagation
MEDIUM
Medium: Trypticase Soy Agar with 5% Sheep Blood (BAP)

GROWTH CONDITIONS
Temperature: 35°C
Atmosphere: Aerobic

PROPAGATION PROCEDURE

Remove the sample vial to a container with dry ice or a freezer block. Keep vial on ice or block. (Do not let vial content thaw)

Open vial aseptically to avoid contamination

Using a sterile loop, remove a small amount of frozen isolate from the top of the vial

Aseptically transfer the loop to BAP

Use streak plate method to isolate single colonies

Incubate inverted plate at 35°C ± 2°C for 18-24 hrs.
Storage Temperature & Biosafety
STORAGE TEMPERATURE: -70°C

BIOSAFETY LEVEL: 2
Appropriate safety procedures should always be used with this material. Laboratory safety is discussed in the current publication of 'BioSafety in Microbiological and Biomedical Laboratories' from the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, and National Institutes of Health.

Disclaimer:
This product is sent with the condition that you are responsible for its safe storage, handling, and use. All materials are the property of the Centers for Disease Control and Prevention (CDC) and have been made available on behalf of the Food and Drug Administration (FDA). This material is not for use in human subjects and may not be redistributed. While CDC uses reasonable efforts to include accurate and up-to-date information on this product sheet, CDC makes no warranties or representations as to its accuracy. CDC is not liable for damages arising from the misidentification or misrepresentation of cultures. Please refer to the Standard Letter Agreement (SLA) for further details regarding the use of this product.
Isolate History
Date Action Performed
04/20/23MIC was updated with a new value for Eravacycline: from '0.5' to '0.12'
04/10/23INT was updated with a new value for Tobramycin: from 'R' to 'I'
04/10/23INT was updated with a new value for Amikacin: from 'R' to 'I'
04/10/23INT was updated with a new value for Tobramycin: from 'S' to 'R'
04/10/23INT was updated with a new value for Amikacin: from 'S' to 'R'
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