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CLSI Standards: Guidelines for Health Care Excellence

Developed by our members for use by the global laboratory community, CLSI’s consensus-based medical laboratory standards are the most widely recognized resources for continually improving testing quality, safety, and efficiency.

Browse our collection of consensus-based medical laboratory standards documents. Choose from print or electronic versions of CLSI standards and guidelines.

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In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
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Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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Performance Standards for Antimicrobial Susceptibility Testing, 32nd Edition

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Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data, 5th Edition

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Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2
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A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition

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Validation of Assays Performed by Flow Cytometry, 1st Edition

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
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Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
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Molecular Methods for Genotyping and Strain Typing of Infectious Organisms, 1st Edition

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