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CLSI Begins Development of a Document on Next Generation IVD Instrument InterfacePosted: 07.22.15

  Wayne, Pennsylvania, USA—July 2015—The Clinical and Laboratory Standards Institute (CLSI) has commenced development of a standard on Next Generation In Vitro Diagnostic (IVD) Instrument Interface (AUTO16). The document development committee consists of individuals from the IVD industry, laboratory information…

CLSI Releases Standards on Point-of-Care TestingPosted: 07.13.15

Wayne, Pennsylvania, USA—July 2015—CLSI recently released new and revised standards on point-of-care testing in relation to glucose measuring and monitoring. Effects of Different Sample Types on Glucose Measurements, 1st Edition (POCT06-Ed1), provides information to assist the clinical and point-of-care staff…

CLSI Announces 2015 Excellence Awards WinnersPosted: 07.10.15

Wayne, Pennsylvania, USA—July 2015—CLSI Excellence Awards are bestowed upon volunteers who are dedicated and committed to CLSI’s mission, and are recognized for significantly contributing their services to the development, implementation, and promotion of consensus standards. The winners were nominated by…

ASM, CAP and CLSI Collaborate to Prepare Materials to Address New Regulations in the LaboratoryPosted: 07.06.15

Representatives from American Society for Microbiology (ASM), College of American Pathologists (CAP), and Clinical and Laboratory Standards Institute (CLSI) have jointly prepared materials for laboratories to use as a guide in development of an antimicrobial susceptibility testing (AST) Individualized Quality…

CLSI Publishes a New Document on Process ManagementPosted: 03.11.15

Wayne, Pennsylvania, USA—March 2015—The Clinical and Laboratory Standards Institute (CLSI) has published a new document titled Process Management (QMS18-Ed1).This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use…

CLSI Publishes a Revised Document on Molecular Diagnostic Methods for Infectious DiseasesPosted: 03.09.15

Wayne, Pennsylvania, USA—March 2015—The Clinical and Laboratory Standards Institute (CLSI) has published Molecular Diagnostic Methods for Infectious Diseases (MM03-Ed3).This report addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment…

CLSI Publishes a New Document on Mass Spectrometry for Androgen and Estrogen Measurements in SerumPosted: 03.02.15

Wayne, Pennsylvania, USA—March 2015—The Clinical and Laboratory Standards Institute (CLSI) has published Mass Spectrometry for Androgen and Estrogen Measurements in Serum (C57-Ed1).This document is intended to aid the laboratorian in developing appropriate procedures for the use of mass spectrometry in the measurement…

Changes Regarding Voting Member Status on Antimicrobial Susceptibility Testing and Antifungal Susceptibility Testing Subcommittees and Specific Associated Working GroupsPosted: 01.29.15

CLSI has maintained the global leadership position in the area of antimicrobial susceptibility testing (AST) for humans and animals for the past 30 years. The work done by AST volunteers is core to CLSI’s mission, as the standards, guidelines, and…

CLSI Publishes a New Practical Guide for the Laboratory on FDA’s Quality System Regulation for Laboratory-Developed TestsPosted: 01.26.15

Wayne, Pennsylvania, USA—January 2015—The Clinical and Laboratory Standards Institute (CLSI) has published Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.This guide converts the requirement complexities of US Food and Drug Administration (FDA) regulations into plain language,…

CLSI and APHL to Co-Host 12th Annual AST Update WebinarsPosted: 01.20.15

Wayne, Pennsylvania, USA—January 2015—The Clinical and Laboratory Standards Institute (CLSI) and the Association of Public Health Laboratories (APHL) will co-host the 12th annual educational update webinars for antimicrobial susceptibility testing (AST). Each January, CLSI updates standards for AST. It is…

 

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