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Find important updates, industry news, and information on CLSI’s upcoming events. Check out past CLSI press releases, upcoming Committees Week, and newsworthy items.
December 4, 2018
Wayne, Pennsylvania, Clinical and Laboratory Standards Institute has published M24--Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes, 3rd Edition and M62--Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes, 1st Edition.
Read MoreNovember 16, 2018
The Clinical and Laboratory Standards Institute has published C49—Analysis of Body Fluids in Clinical Chemistry. This guideline provides guidance to medical laboratories for the appropriate application of measurement procedures for body fluid testing and for reporting results. This guideline primarily focuses on the recommended practice for verification of measurement procedures for measurands in body fluids and is applicable for laboratory testing requests on body fluids that do not have performance claims in the manufacturer’s package insert or an equivalent validated laboratory-developed test.
Read MoreOctober 24, 2018
The Clinical and Laboratory Standards Institute announces the publication of M11--Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria. M11 describes the reference standard agar dilution method (Wadsworth) and the alternative broth microdilution method.
Read MoreSeptember 25, 2018
Clinical and Laboratory Standards Institute has published M48—Laboratory Detection and Identification of Mycobacteria. This guideline covers topics related to laboratory diagnosis of mycobacterial infections.
Read MoreAugust 16, 2018
CLSI announces the publication of EP34—Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st ed. EP34 provides recommendations for establishing a dilution scheme to be used for patient specimens that contain measurand concentrations in the extended measuring interval above a measurement procedure’s upper limit of quantitation.
Read MoreJuly 25, 2018
The Clinical and Laboratory Standards Institute announces the upcoming publication of QMS22—Management of Paper-based and Electronic Laboratory Information.This guideline is intended to help laboratories meet quality management system requirements for quality system essential (QSE) Information Management. In addition to discussing the requirements for how data and information are generated and entered into paper-based or electronic recordkeeping systems, this guideline also offers suggestions and examples for meeting the intent of the requirements.
Read MoreJuly 17, 2018
The Clinical and Laboratory Standards Institute announces the publication of MM18—Interpretive Criteria for Identification of Bacteria and Fungi by Targeted DNA Sequencing. MM18 includes information on sequencing DNA targets of cultured isolates, provides a quantitative metric for perceiving microbial diversity, and can serve as the basis to identify microorganisms. By establishing interpretive criteria for microorganism identification by targeted DNA sequencing, this guideline provides structure to laboratories that identify microorganisms for medical use.
Read MoreJuly 5, 2018
Clinical and Laboratory Standards Institute has published VET01–Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals and its supplement, VET08.
Read MoreJune 29, 2018
Clinical and Laboratory Standards Institute guideline C63—Laboratory Support for Pain Management Programs, provides recommendations for medical laboratory toxicology-based testing services for the care and treatment of persons in pain management programs. The intended users of this guideline include medical laboratory scientists and personnel, medical technologists, hospital administrators, physician office personnel, risk managers, pharmacists, and health care providers tasked with implementing pain management testing for their institutions or networks.
Read MoreJune 12, 2018
The Clinical and Laboratory Standards Institute has published Validation and Verification of Multiplex Nucleic Acid Assays—MM17. MM17 discusses analytical validation and verification of qualitative multiplex nucleic acid assays. Topics covered include sample preparation, a general discussion of multiplex methods and technologies, reference and quality control materials, data analysis, and results reporting. Clinical validity and utility are briefly reviewed. Detailed recommendations for appropriate analytical validation and verification, based on the most current guidance documents, are provided.
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