Download - 2 clsi & eucast. κριτήρια αξιολόγησης
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“ π μα μ α α χ .
Ε α α Ο απ υ α μ π Σ Ημ ί α Ε ΕΒ 2014, α
π χ α α μ υ α μμα μ α
Ευ πα υπα;
CLSI & EUCAST. α α
Ε. μπ
α πα , Β υ α Ε , μ μα . αί “ . & . υ α Σ
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…… υ μα α α α μ α:
CLSI EUCAST
• Clinical Laboratory Standard Institute, Η
• European Committee on Antimicrobial Susceptibility Testing
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CLSI - www.clsi.org
• α 1968 απ 31 α α α π μ απ 15 α Η μ χ ▫ πί υ α α α α ▫ μ α π υ α α α π α α ▫ π ου α πα μ πίπ
• Έχ 2000 μ - α α 1800 απ 69 χ • ί υ φα μ α 116 χ • υ α α μ φ ί Η ( ί α, α, υ α ία) • Χ μα ί α απ υ μ μ ( μ π α
, μ χα ί , π μ α ί ) α π π
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9 Consensus Committees
Consensus Committee on Microbiology
Subcommittees on Antimicrobial ST Antifungal ST Veterinary ST
Working Groups (WGs)
Text and Table Quality Work, Staphylococci, Enterobacteriaceae……
Government agencies, Industry, Laboratory health care professionals
Standards, Guidelines, Reports
Ψηφοφο ία / 5 άδια
Β μ π ί
Committee membership
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υ ί α μ ί (FDA,
CDC….)
α α μ ί α
πα π μί , ASM, ATCC
Φα μα υ μ χα ί -
μ χα ί α
μ
α α ί
Subcommittee on Antimicrobial Susceptibility Testing
….. μ π π α α α α α
μα
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Έ υπα υ CLSI
• Performance Standards for Antimicrobial Susceptibility Testing (AST), M100-S24
• Performance Standards for Antimicrobial Disk Susceptibility Tests, M02-A11
• Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that grow Aerobically, M07-A9
• Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolates or Fastidious Bacteria, M45
• Methods for AST for Anaerobic Bacteria, M11-A48 • Principles and Procedures for Detection of Fungi in Clinical
Specimens. Direct examination and Culture, M54 • Methods for AST for Human Mycoplasmas, M43
• ……π α απ 32 υπα Ο Β ΘΕΣ Ε Η Ω Η
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μ α α α / α α αφ
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Cefepime2014
30μg ≥25mm S
19-24 ≤18mm
R
≤2mg/L
S
4-8 ≥16mg/L
R
Susceptible-Dose Dependent (SDD)
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1997
ISC
FESCI
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χ EτCAεσ • Θ π υ πα ί υα ία / α χ
α π α χ • υπ π ί μ
• μπ α μ α ί χ υ φ ί (CLεI α
π π α μμα ) α “ υ αί Σ μα α χ υ μ α α χ
• Ε παί υ ( α φ α)
• Β μ υ ία π μ ί cut-off (ECOFFs)
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Επ μ (Epidemiological cut-off, ECOFF)
• Η μ MIC π υ α α φ α Wσ μ α π υ μ , α αχ ί Wild Type (WT) απ Non Wild Type (NWT) π υ μ • Wσ: φυ μ α π υ μ ί α πί υ μ α α μ χα μ α χ • NWT: α μ α π υ μ Έχ απ πί μ α α μ χα μ α χ
υ μ α
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Επ μ (Epidemiological cut-off, ECOFF)
• Εί α φυ /
μ μ • π ί ί μ α ία
/ π μ • χ α α
α χ • ί α α α μ
MICs • Ε φ α ECOFF:
Wσ≤Xmg/L
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K υα ία S α χ R (clinical breakpoint)
• α ί α απ : ▫ Kα α μ MICs ▫ PK α PD μ α
▫ M μ
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K υα ία S α χ R (clinical breakpoint)
• Εί α ί μ α ία α α ί α απ απ μα π • Ε α α απ χ μα α χ
• π ί α α α α μ α χ α π μ
μ α • Β αχ ί α α (R) απ α υαί α (S)
• Ε φ α MIC: ε≤X, R>Y mg/L α μ αφ α α α : S≥X, R<Y mm
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www.eucast.org
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«_»: υ α χ υα ία , α ί α ί α α απ μα
«IP»: in preparation, π μα ία
« »: non applicable, μ φα μ μ
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« Ε»: insufficient evidence, μ πα απ χ ία.
αφ α MIC, χ ί α π ί υ μ ί υ ε/I/δ.
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• Γ φυ α χ
• α π φα π α χ
• Χ μ υ α (Expert rules
subcommittee EUCAST)
Leclercq R, Cantón R, Brown DF, et al. EUCAST expert rules in antimicrobial susceptibility testing. Clin Microbiol
Infect. 2011 Oct 21. doi: 10.1111/j.1469-0691.2011.03703
Ε μ υ α μα α μμα
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Ε μ υ ί α “Expert rulesΣ α μ α 3 πίπ α (A, B, C)
C
• A. Επα ί ί
• B. πα ί ί
• C. αμία , α
μ μ μ α
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EUCAST
CLSI
π π υ Επ μ . H υμ ΕCDC α Εuropean edicine gency (EMA) υ υ μ .
π π μ α ία α Επ μ .
Χ μα ί α απ ESCMID α ΕCDC α Ε Επ π μμα (NACs).
Χ μα ί α απ υ μ ( μ α ία, α α, α , μ π α ) α
π π .
H φα μα υ μ α ία μ υμ υ υ .
φα μα υ μ α ία ί α η α απ φ .
Η η αποφ γ α “ υ αί ”, ί φ φ ία.
Η απ φ ί α 5 α ο φ φ ί
5 υ α .
2 υ α .
Τα γγ αφα η ο οπο ο α μ απ φ .
Β μ π α υ μα
Β αφα, α α ί υ . Β α μα μ πί π μ .
α breakpoints (ΕCOFFs).
breakpoints (CBs).
Έ μ μ υ ία
Β υ ία, μ μ υ ία FDA. O α α υ μα α υ π π α π
π α αφ FDA.
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Ε μ υ ί α “Expert rulesΣ Β α ί α 3 πίπ α (A, B, C)
C
• A. Επα ί ί ,
α ί S υπ χ απ υχία απ ία
Staph: FOXR, R α α -α αμ
• B. πα ί ί ,
α ί S ί υπ χ απ υ απ υχία
Staph: GENR, R AMGs
• C. αμία , α μ μ α ίχ υ
π π α απ φ υχ ί χ Staph: LEVOR, R FQs
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• Γ φυ α χ ▫ Enterococci: α χ φα π ί • α π φα π α χ ▫ S. aureus VANR, LINR, DPR • Χ μ υ α (Expert rules) ▫ E μ ία μ χα μ α χ
Leclercq R, Cantón R, Brown DF, et al. EUCAST expert rules in antimicrobial susceptibility testing. Clin Microbiol
Infect. 2011 Oct 21. doi: 10.1111/j.1469-0691.2011.03703
Ε μ υ α μα α μμα (expert rules subcommittee EUCAST)
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χυ ί (DD) Β αφ - μ
▫ πυ α α ία ί α ί , μ αί π α α
▫ μ α α μα ί α ί (0.5 McF)
▫ Η α α α μ απα μ α ▫ υ π α (16-
18h α 350C) χ ί ▫ α π υπα χ (QC)
ί α π ίπ υ α ί α ▫ μ αφ α
α υα ία / α χ
▫ Γ α α απα μ α EUCAST: MHF (MH + 5%
απ μ αίμα α υ α 20mg/L -NAD) Haemophilus spp,
Streptococci, M. catarrhalis, L. monocytogenes, C. jejuni, C. coli, Corynebacterium spp, P. multocida
CLSI: Haemophilus Test Medium (HTM) Haemophilus spp
MH+5% αίμα π υ Streptococci, L.
monocytogenes……..
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9 Consensus Committees
Consensus Committee on Microbiology
Subcommittees on Antimicrobial ST Antifungal ST Veterinary ST
Working Groups (WGs)
Text and Table Quality Work, Staphylococci, Enterobacteriaceae……
Government agencies, Industry, Laboratory health care professionals
Standards, Guidelines, Reports
Ψηφοφο ία / 5 άδια
Β μ π ί