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Standards Status
Vote and Deadlines

Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays (H21-A5); Immunoassay Interference by Endogenous Antibodies (I/LA30-P); Implementation Guide of POCT1 for Healthcare Providers (POCT2-P)

CLSI submits the following for vote as a candidate-for-advancement consensus documents.  The documents and ballots are available to delegates and alternates of Active and Associate Active member organizations through CLSI Forums.  

H21-A5Collection, Transport, and Processing of Blood Specimens for Testing Plasma-
Based Coagulation Assays; Approved Guideline – Fifth Edition

This guideline contains procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and provides general recommendations for performing the tests. The deadline for the completed ballot for H21-A5 to be received at the CLSI offices is 29 June 2007.

Second Notice

I/LA30-PImmunoassay Interference by Endogenous Antibodies; Proposed Guideline
The guideline discusses the nature and causes of interfering antibodies as well as their effects on immunoassays and mechanisms by which interference occurs. Methods to identify and characterize the interferences will be addressed along with assessment of methods used to eliminate interference. The deadline for the completed ballot for I/LA30-P to be received at the CLSI offices is 25 May 2007.

POCT2-PImplementation Guide of POCT1 for Healthcare Providers; Proposed Guideline
This document identifies and describes the particular features that a POCT1 compliant device should ideally have. These features are divided into obligatory and desirable categories. Key terms are identified and the most frequent usecases are presented. The guideline thus gives the healthcare provider or end-user a practical basis for establishing a list of features or questions to be addressed by the vendor of a compliant device. The deadline for the completed ballot for POCT2-P to be received at the CLSI offices is 7 May 2007.


Under our Administrative Procedures, a CLSI document approved by the area committee at the first level of the consensus process is submitted to delegates as a “candidate-for-advancement” consensus document. This begins the voting and approval period by the delegates.

As a delegate, your vote is to affirm (or reject) the document for advancement as a CLSI document. Please send your completed ballot to the CLSI offices by the above deadline.

In the consensus process, comments are invited at each publication stage. In each edition, the responsible committee includes a summary of comments on the prior edition and its responses to them. Any comments received on a candidate-for-advancement consensus document as a result of delegate voting and consensus review will be addressed by the committee during the document’s advancement.

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