General Principles and Guidelines on the Use of Mass Spectrometry in the Clinical Laboratory (C50-P); Immunoassay Interference by Endogenous Antibodies (I/LA30-P); Blood Collection on Filter Paper for Newborn Screening Programs (LA4-A5); Laboratory Detection and Identification of Mycobacteria (M48-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.

I/LA30-P—Immunoassay 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.

LA4-A5—Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Fifth Edition
This document addresses the issues associated with specimen collection, the filter paper collection device, and the application of blood to filter paper, and provides uniform techniques for collecting the best possible specimen for use in newborn screening programs. The deadline for the completed ballot for LA4-A5 to be received at the CLSI offices is 30 April 2007.

POCT2-P—Implementation 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.

Second Notice

C50-P—General Principles and Guidelines on the Use of Mass Spectrometry in the Clinical Laboratory; Proposed Guideline
This guideline provides a general understanding of mass spectrometry and the principles that dictate its application in the clinical laboratory. It includes guidance, references, and quality assurance markers that will assist with the implementation and correct operation of a mass spectrometry (MS) system for its many applications. Information on maintaining optimum performance, approaches to ensuring accurate and precise mass measurement, verification of methods, quality control of assays within and between instruments, instrument troubleshooting, sample preparation, interpretation of results, and limitations of the technology are included. The deadline for the completed ballot for C50-P to be received at the CLSI offices is 16 April 2007.

M48-P—Laboratory Detection and Identification of Mycobacteria; Proposed Guideline
This document provides guidance to clinical mycobacteriology laboratories on the most optimum approach for the diagnosis of mycobacterial infections. The deadline for the completed ballot for M48-P to be received at the CLSI offices is 16 April 2007.

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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