The document is designed to guide microbiology laboratories in the detection of bacteremia and fungemia (bacteria and fungi in the blood), which are life-threatening conditions requiring rapid and accurate diagnosis.
A zoonotic pathogen that can cause severe localized or systemic infections in humans.
While many of the most common bacterial pathogens are covered in CLSI benchmark standards like M02, M07, and M100, there are numerous "orphan" organisms that cause serious infections but for which standardized testing guidance does not exist in those other documents. CLSI M45 was specifically created to provide comprehensive guidance and breakpoints for this important group of fastidious and infrequently isolated bacteria.
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Increasingly recognized as multidrug-resistant opportunistic pathogens in hospital settings.
The M45 document covers a diverse array of Gram-positive and Gram-negative bacteria. Some of the most clinically relevant groups include: 1. Fastidious Gram-Negative Bacilli
Are you aligning your procedures with ?
Halophilic organisms requiring specific salt concentrations for optimal growth and testing. Testing Methodologies Recommended in M45
Always check that your laboratory standard operating procedures (SOPs) match the current active edition of the M45 document.
Accrediting bodies like the College of American Pathologists (CAP) and the Joint Commission require clinical laboratories to validate or verify their susceptibility testing methods. Aligning laboratory protocols with the current edition of CLSI M45 satisfies stringent regulatory requirements and ensures high-quality laboratory performance. 3. Guidance on Local Epidemiology The document is designed to guide microbiology laboratories
: Provides testing conditions and interpretive criteria for organisms like Corynebacterium spp., Abiotrophia spp., Granulicatella spp., and Bacillus spp. (excluding B. anthracis ).
Including Vibrio vulnificus and Vibrio cholerae . Core Elements of the M45 Tables
I can help check the CLSI website for the most recent edition, or if you can tell me which specific organism you are trying to test (e.g., Nocardia , Eikenella ), I can provide more specific guidance from the standard. Share public link CLSI M45 was specifically created to provide comprehensive
Standard AST standards rely heavily on high-volume data to establish clinical breakpoints. For rare or fastidious organisms, gathering this data is incredibly difficult. CLSI M45 addresses several specific challenges:
The document provides specific tabular data, testing recommendations, and interpretive breakpoints for an array of fastidious or rarely isolated bacterial genera, including: