CLSI Releases Infobase™ 2008
Searchable CD-ROM of CLSI standards and guidelines
Wayne, Pennsylvania, USA—April 2008—Clinical and Laboratory Standards Institute (CLSI) recently released the 2008 edition of Infobase™, which is a searchable CD-ROM including over 180 CLSI standards and guidelines for medical testing best practices.

As one of the highlights of CLSI’s electronic product offerings, Infobase™ 2008 includes approved- and proposed-level documents with convenient search capabilities.
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CLSI Releases Guidelines for Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
Wayne, Pennsylvania, USA—April 2008— A measured or observed laboratory test result from a person (usually a patient) is compared with a reference interval for the purpose of making a medical diagnosis, therapeutic management decision, or other physiological assessment. It is important to develop reference intervals using a systematic process that takes into account the various influences on the measured laboratory test results.

Clinical and Laboratory Standards Institute (CLSI) recently published a document, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Proposed Guideline—Third Edition (C28-P3), which offers a protocol for determining reference intervals that meet the minimum requirements for reliability and usefulness. The guideline focuses on health-associated reference values as they relate to quantitative clinical laboratory tests. Included are various requirements for studies to determine reference values for a new analyte or a new analytical method of a previously measured analyte. Also discussed is the transfer of established reference values from one laboratory to another.
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New CLSI Guideline Provides Protocols for Verification and Validation of Multiplex Nucleic Acid Assays
Wayne, Pennsylvania, USA—April 2008— Multiplex assays detect the presence of and discriminate two or more analytes simultaneously in the same sample. The number of commercially available multiplex assays is increasing rapidly, as is the number of laboratory-developed multiplex assays, and these use a variety of technologies and instrument platforms. Multiplex testing provides significant challenges to the laboratory with regards to appropriate verification and validation testing, and especially the acquisition of appropriate control and reference materials to conduct the testing.

Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline (MM17-A), which provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials.
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CLSI Publishes New Guideline for Continuous Interstitial Glucose Monitoring
Wayne, Pennsylvania, USA—April 2008—Continuous interstitial glucose monitors (CGM) are medical devices that measure glucose in the interstitial fluid just under the skin. CGM offers the patients the potential of monitoring their glucose and managing insulin levels without repeated finger sticks. Because CGM offers the ability to report trends in glucose levels over time, the development of new evaluation methods for determining the accuracy of CGM devices is necessary. As more manufacturers develop CGM devices, consistent evaluation protocols become more important.

Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Performance Metrics for Continuous Interstitial Glucose Monitoring; Proposed Guideline (POCT5-P), which specifies requirements and recommendations for methods for determining analytical and clinical metrics of CGM. 
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