ArticleJournal of clinical microbiology2025
Major updates to FDA-recognized Clinical and Laboratory Standards Institute breakpoints are a win for the fight against antimicrobial resistance.
Article in Journal of clinical microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- Prevalence of methicillin-resistant coagulase-negative staphylococci and their antibiotic resistance profile in Zagazig University intensive care units.Molecular biology reports · 2026Article
- Deconstructing cancer in 3D: models, mechanisms, and personalized solutions.Molecular cancer · 2026Review
- Advancing antimicrobial therapy: evaluating the ASTar (Q-linea) System for rapid AST in Gram-negative bloodstream infections.Microbiology spectrum · 2026Article
- Microbial Contamination, Hygienic Practices, and Antimicrobial Resistance Patterns of Food Milling Machines in Somanya, Ghana.International journal of food science · 2026Article
- Dilution susceptibility testing method evaluation for the combination of ceftibuten and avibactam against Enterobacterales.Journal of clinical microbiology · 2025Article
- Overview of changes in the Clinical and Laboratory Standards Institute Performance Standards for Antimicrobial Susceptibility Testing: M100 32nd and 33rd editions.Journal of clinical microbiology · 2025Review
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Antimicrobial resistance (AMR) is a pressing crisis for global health. At the front lines of detecting AMR are clinical laboratories, which perform antimicrobial susceptibility testing (AST). In recent years, the ability of laboratories to conduct this testing in the United States has been challenged by changing interpretive standards and increased regulation surrounding laboratory testing, most recently U.S. Food and Drug Administration (FDA) regulation of laboratory-developed tests. In early 2025, the FDA recognized many breakpoints published by the Clinical Laboratory Standards Institute, including for microorganisms that represented an unmet need. This unprecedented step heralds a pragmatic approach to AST by the FDA and is a major win for laboratories, clinicians, and patients in the United States and globally. In this commentary, we discuss these changes and the impact on clinical laboratories.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.