CLSI M45-A2 PDF

Prompt, accurate identification of a bacterial pathogen is one of the most valuable services the microbiology laboratory provides for clinicians in its efforts to positively impact patient care. However, there are instances in which the sensitivity of such a pathogen cannot be predicted simply based on the identity of the organism. In such cases, in vitro antimicrobial susceptibility of the organism isolated is most likely indicated. Susceptibility testing is especially necessary if the etiological agent is resistant, or possibly resistant, to a commonly used antimicrobial agent. Established guidelines exist for susceptibility testing of some organisms. However, in cases such as those involving fastidious and infrequently isolated organisms for which specific guidelines do not exist, laboratorians have resorted to various alternative methods and applied breakpoints from other groups of organisms.

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Prompt, accurate identification of a bacterial pathogen is one of the most valuable services the microbiology laboratory provides for clinicians in its efforts to positively impact patient care.

However, there are instances in which the sensitivity of such a pathogen cannot be predicted simply based on the identity of the organism. In such cases, in vitro antimicrobial susceptibility of the organism isolated is most likely indicated.

Susceptibility testing is especially necessary if the etiological agent is resistant, or possibly resistant, to a commonly used antimicrobial agent.

Established guidelines exist for susceptibility testing of some organisms. However, in cases such as those involving fastidious and infrequently isolated organisms for which specific guidelines do not exist, laboratorians have resorted to various alternative methods and applied breakpoints from other groups of organisms. According to James H. Jorgensen, PhD, chairholder of the CLSI working group that developed the document, it has long been accepted that for the most effective management of bacterial infections, laboratories must be able to determine susceptibility or resistance to therapeutic agents.

Jorgensen identifies these developments as the most obvious benefits of M Janet A. Jorgensen and Hindler both agree that this revised guideline is very timely, in light of the increasingly common challenges faced by laboratories performing susceptibility testing on these organisms, including increased pressure from clinicians to provide susceptibility data quickly, and the need for reliable methods to identify emerging resistance.

Working group member Paul C. Therefore, laboratories need specific guidelines on how to perform valid susceptibility testing without using the US Food and Drug Administration FDA -cleared instrumentation and commercial test systems found in most laboratories. Before the publication of this guideline, a review of the literature revealed very few systematic studies on testing these organisms, Dr.

Jorgensen adds. Jorgenson stresses the importance of understanding their distinction from M This guideline is based somewhat on standardized procedures in other documents, but contains specific instructions on when and how to perform antimicrobial susceptibility testing of fastidious or infrequently isolated organisms that might be resistant to therapy commonly prescribed through antibiotics.

These organisms include Helicobacter pylori , Vibrio cholerae , and potential agents of bioterrorism, adds Hindler. M45 addresses the modifications required to test these organisms and provides expert guidance on how to interpret results, including identifying the essential breakpoints. Jorgensen offers an example of how this guideline might be used in a typical laboratory. Jorgensen said. For some of the organisms, a disk diffusion method is described, and this method can be easily adopted by most clinical laboratories performing disk diffusion testing.

Commercial susceptibility testing devices are not specifically addressed by M The methods described are generic reference methods that can be used for routine susceptibility testing by most clinical laboratories. These methods may also be used to evaluate commercial devices for routine use.

Results generated by these reference methods may in fact be used by regulatory agencies to evaluate the performance of commercial systems as part of their approval systems. Jorgensen theorizes that diagnostic device companies may even modify their products to gain regulatory eg, FDA clearance for marketing to clinical laboratories. M45 does not suggest that laboratories test all infrequently encountered or fastidious isolates, especially if they are of dubious clinical significance, Dr.

Jorgensen emphasizes. However, clinicians need prompt guidance on treating organisms that can cause serious, life-threatening infections eg, bacteremia, endocarditis, and meningitis.

While comprehensive, the guideline is not prescriptive, and allows some degree of customization of criteria and policies by each laboratory and its medical staff. Its encompassing nature establishes M45 as an invaluable resource to various constituencies, including the clinical laboratory. Interested facilities should contact CLSI for more information, including purchasing options, on this essential document.

James H. Paul C. Google Preview. His e-mail address is glenmcdan aol. CLSI is a global, nonprofit organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Sign In. Advanced Search. Search Menu. Article Navigation.

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