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Panel:   Custom 2024-8091 (Custom)
AR Bank # 0016 Klebsiella pneumoniae
Study ID: BIT-16

Biosample Accession #: SAMN04014857

mCIM Result: Negative    
MLST: 3921(Pasteur)


Panel:  Enterobacterales Carbapenem Breakpoint (BIT)  |  Custom BIT-Claim (Custom)  |  Custom 2024-8091 (Custom)


MIC (μg/ml) Results and Interpretation
Drug MIC (μg/ml) INT
Amikacin <=1S
Ampicillin >32R
Ampicillin/sulbactam 116I
Aztreonam <=2S
Aztreonam/avibactam 10.12---
Cefazolin 4I
Cefepime <=0.5S
Cefepime/zidebactam 20.06---
Cefotaxime <=0.5S
Cefotaxime/clavulanic acid 1 6<=0.25---
Cefoxitin >16R
Ceftazidime <=1S
Ceftazidime/avibactam 1<=0.5S
Ceftazidime/clavulanic acid 1 6<=0.5---
Ceftolozane/tazobactam 11S
Ceftriaxone <=1S
Ciprofloxacin <=0.25S
Colistin 50.5I
Doripenem <=0.12S
Eravacycline 32NS
Ertapenem <=0.12S
Gentamicin <=0.25S
Imipenem <=0.5S
Imipenem/relebactam 10.06S
Imipenem+chelators 4<=0.25---
Levofloxacin 0.5S
Meropenem <=0.12S
Meropenem-vaborbactam 1<=0.5S
Nitrofurantoin >128R
Omadacycline 316R
Piperacillin/tazobactam 116SDD
Plazomicin 0.25S
Tetracycline 16R
Tigecycline 34I
Tobramycin <=0.5S
Trimethoprim/sulfamethoxazole 1<=0.5S
SDD (Susceptible Dose Dependent)
S – I –R Interpretation (INT) derived from CLSI 2024 M100 S34
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.
6 Screen test for Extended-Spectrum-β-lactamase (ESBL) production (CLSI M100). Per CLSI, use of the ESBL test is limited to isolates of Klebsiella pneumoniae, K. oxytoca, Escherichia coli, and Proteus mirabilis. It should be noted that the presence of other β-lactamases (carbapenemases and/or AmpC) or porin alterations can mask the ESBL production and confound the interpretation of the ESBL screen test.
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 LEN-27
Fosfomycin KDEA
Phenicols/Bicyclomycins oqxA, oqxB9
 
Disclaimer:
The resistance mechanisms listed were identified by analysis of whole genome sequence using the ResFinder database (last updated June 2, 2016 and accessed on October 25, 2016). This analysis does not include mutations that may result in antibiotic resistance or resistance determinants added to newer versions of the ResFinder database or other antimicrobial resistance gene databases. Biosample accession numbers have been provided so that users can analyze the data on their own if so desired.
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
05/31/23INT was updated with a new value for Omadacycline: from '---' to 'R'
05/31/23MIC was updated with a new value for Omadacycline: from '---' to '16'
05/31/23Drug was added: Omadacycline
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