CLSI M45 PDF

CLSI document MA2. Wayne, PA: Clinical and Laboratory Standards Institute; Proposed Guideline. October Approved Guideline. May 15 Aug CLSI M Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Third Edition. Fastidious Organisms: CLSI MA2 update. Diane M. Citron. SWACM, R.M. Alden Research Lab. Culver City, CA. History. ▫ CLSI has provided testing.

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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.

csi Working group member Paul C. Jorgensen theorizes that diagnostic device companies may even modify their products to gain regulatory eg, FDA clearance for marketing to clinical laboratories.

A Case Report and Literature Review. 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.

The Experts James H. Receive exclusive offers and updates from Oxford Academic.

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. Jorgensen offers an example of how this guideline might be used in a typical laboratory. Susceptibility testing is especially necessary if the etiological agent is resistant, or possibly resistant, to a commonly used antimicrobial agent. CLSI is a global, nonprofit organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community.

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Commercial susceptibility testing devices are not specifically addressed by 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.

The methods described are generic reference methods that can be used for routine susceptibility testing by m54 clinical laboratories. Its encompassing nature establishes Clsu 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.

Close mobile search navigation Article navigation. These methods may also be used to evaluate commercial devices for routine use. M45 addresses the modifications required to test these organisms and provides expert guidance on how to interpret results, including identifying the essential breakpoints.

Related articles in Google Scholar.

Sign In or Create an Account. According to James H. However, clinicians need prompt guidance on treating organisms that can cause serious, life-threatening infections eg, bacteremia, endocarditis, and meningitis. However, there are instances in which the sensitivity of such a pathogen cannot be predicted simply based on the identity of the organism. Results generated by these reference methods may in fact be used by regulatory agencies to evaluate the performance of commercial systems m445 part of their approval systems.

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Clai stresses the importance of understanding their distinction from M Before the publication of this guideline, a review of the literature revealed very few systematic studies on testing these organisms, Dr.

Oxford University Press is a department of the University of Oxford. M45 does not suggest that laboratories test all infrequently encountered or fastidious isolates, especially if they are of dubious clinical significance, Dr.

Email alerts New issue alert. While comprehensive, the guideline is not prescriptive, and allows some degree of customization of criteria and policies by each laboratory and its medical staff.

It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. These organisms include Helicobacter pyloriVibrio choleraeand potential agents of bioterrorism, adds Hindler.

Jorgensen identifies these developments as the most obvious benefits of M His e-mail address is glenmcdan aol. Jorgensen, PhD, chairholder of the CLSI working group that developed the document, it has long flsi accepted that for the most effective management of bacterial infections, laboratories must be able to determine susceptibility or resistance to therapeutic agents.