Medical decisions may be based on obsolete breakpoints, leading to incorrect treatment reporting.
: Includes specialized procedures for public health laboratories to handle potential bacterial agents of bioterrorism. clsi document m45 pdf
: The third edition (2015) of CLSI M45 is fully recognized by the U.S. Food and Drug Administration (FDA) as a consensus standard. This recognition is critical for manufacturers who need to validate their AST devices against a recognized standard for regulatory approval. Medical decisions may be based on obsolete breakpoints,
: The most direct way is to purchase the PDF from CLSI's official shop or authorized distributors (e.g., ANSI, Techstreet). The list price is typically $180.00 . CLSI members receive a significant discount (up to 70%) off the list price. Food and Drug Administration (FDA) as a consensus standard
The M45 document consolidates testing criteria for a diverse group of organisms that clinical labs see less frequently but are opportunistic or highly pathogenic. Examples include:
If an organism is covered in M100, that standard takes precedence over M45. ResearchGate 5. Best Practices for Implementing M45 Always Use the Current Version:
