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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.
September 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.
Read MoreMay 29, 2018
The Clinical and Laboratory Standards Institute has published two clinical interference testing documents: Interference Testing in Clinical Chemistry, 3rd Edition (EP07-Ed3) and Supplemental Tables for Interference Testing in Clinical Chemistry, 1stEdition (EP37-Ed1). EP07 provides background information, guidance, and experimental procedures for investigating, identifying, and characterizing the effects of interferents on clinical chemistry test results. EP37 includes recommended testing concentrations for analytes and endogenous substances that may interfere in clinical chemistry measurement procedures and is intended for use with the evaluation procedures in EP07.
Read MoreJanuary 26, 2018
Wayne, Pennsylvania, USA—January 2018—CLSI Excellence Awards are bestowed upon volunteers who are committed to CLSI’s mission. Recipients are recognized for dedicating significant time and effort to the development, implementation, and promotion of voluntary consensus standards. The recipients are nominated by their peers and selected by the CLSI Awards Committee. CLSI celebrates the achievements of volunteers, as they are fundamental to the development of best practices in clinical and laboratory testing.
Read MoreDecember 14, 2017
The US Food & Drug Administration (FDA) has taken an important step to improve public health by creating a website to make critical updates regarding antimicrobial drugs available to health care professionals. This information helps laboratories report the most current information to health care providers about what type of infection a patient has and what the most effective treatment will be. The website provides information on the most up-to-date Susceptibility Test Interpretive Criteria (STIC), also known as breakpoints. Breakpoints help determine whether a specific bacteria or fungi are susceptible to (ie, will respond to treatment with) antibacterial or antifungal drugs. According to the FDA, “This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria.”
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