12 January 2005   
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Recently Approved Documents
Evaluation of Matrix Effects (EP14-A2); Maternal Serum Screening (I/LA25-A); Nucleic Acid Sequencing (MM9-A)

Clinical and Laboratory Standards Institute is pleased to announce that the following documents have been approved by the Board of Directors for publication.  See the text following this list for information on options for member and nonmember organizations to obtain copies.

EP14-A2Evaluation of Matrix Effects; Approved Guideline—Second Edition
This document provides guidance for evaluating the bias in analyte measurements that is due to the sample matrix (physiological or artificial) when two measurement procedures are compared.

-Second Notice-

I/LA25-AMaternal Serum Screening; Approved Standard
This document addresses the steps required to provide reliable screening and reporting using examples of serum markers currently in common use (AFP, hCG, uE3, DIA).  Outcome evaluation, information management, and calculation of risk are also emphasized in this standard.

MM9-ANucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline
This document addresses automated, PCR-based, dideoxy-terminator, and primer extension sequencing done on gel- or capillary-based sequencers. Topics covered include specimen collection and handling; isolation of nucleic acid; amplification and sequencing of nucleic acids; interpretation and reporting of results; and quality control/assessment considerations as appropriate.


Our procedures have been designed to ensure that consensus has been achieved when a standard or guideline is published at the approved level. This means that a document has been rigorously reviewed by the authoring subcommittee, the area committee overseeing the project, the Board of Directors, and the medical-testing community which participates in the consensus process by carefully reviewing and commenting on the standard or guideline. The listed approved consensus documents are available for purchase.

You may automatically receive or select approved-level documents as a member benefit. Find out more about joining CLSI. View membership options and benefits. 
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