13 July 2005   
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Press Releases
Parasite Recovery and ID (M28-A2); Performance Verification for Precision and Trueness (EP15-A2); Bleeding Time Test Performance (H45-A2); External RNA Controls in Gene Expression Assays (MM16-P); Diagnostic Nucleic Acid Microarrays (MM12-P)

CLSI: Parasitic ID Guidelines as Borderless Hazard Continues to Hit Home

Wayne, PA, USA – 13 July 2005 – Microbiologists report that temperate weather, impracticable ideals of cleanliness, and geographic isolation from the Southern world, have contributed to a widespread delusion in the U.S. and other first-world nations that parasites are a distant problem.  Therefore the diagnosis of intestinal organisms in first-world nations often begins as an etiologic mystery, dangerously consuming time and resources. 

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CLSI Revision:  Diverse Lab Settings for Performance Claims Verification

Wayne, PA, USA – 13 July 2005 – Responding to clinical laboratory desire to make the document useful to nonstatisticians, Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document User Verification of Performance for Precision and Trueness; Approved Guideline—Second Edition (EP15-A2), is designed for use in a variety of laboratory settings, from the point-of-care or physician’s office laboratory to the large clinical laboratory. The protocol is nonetheless sufficiently rigorous to provide statistically valid conclusions for verification studies. 

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CLSI Guideline Updates Safety Practices for Bleeding Time Testers, Manufacturers

Wayne, PA, USA – 13 July 2005 – Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document Performance of the Bleeding Time Test; Approved Guideline—Second Edition (H45-A2) introduces the most current guidelines for performing the template procedure of the bleeding time test.  By controlling the length and depth of the incision, the template procedure of the bleeding time test improves reproducibility.  However, this type of test remains affected by a number of variables. 

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CLSI Responds to Need for Industry-Recognized Microarray Controls

Wayne, PA, USA – 13 July 2005 – The changes that have taken place in the research and clinical communities over the past two decades—in the scope and breadth of the designs, practices, analyses, and very imaginations of clinical and laboratory researchers—owe largely to the advances in technologies for nucleic acid amplification, genome analysis, and microarray platforms.  Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document Use of External RNA Controls in Gene Expression Assays; Proposed Guideline (MM16-P) outlines protocols supporting the use of external RNA controls in microarray and QRT-PCR-based gene expression experiments.

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Diagnostic Nucleic Acid Microarrays Guideline to Serve as Laboratory, Educational Resource

Wayne, PA, USA – 13 July 2005 – Diagnostic Nucleic Acid Microarrays; Proposed Guideline (MM12-P), developed through the consensus process of the Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS), in partnership with the International Federation for Clinical Chemistry (IFCC), is intended by its authoring subcommittee to become an educational resource for molecular genetics.  MM12-P will define the most favorable conditions and principles for the provision of accurate molecular information. 

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