Protocol for Establishment of Sample Stability in Clinical Chemistry and Toxicology

The Clinical and Laboratory Standards Institute requests volunteers to serve as subcommittee members for a new voluntary consensus project. The project description and specific qualifications needed are provided below: 

NEW PROJECT:
Protocol for Establishment of Sample Stability in Clinical Chemistry and Toxicology

Description:
Because there are well-established standards for collection of blood specimens by venipuncture (NCCLS H3-A5) and guidelines for the handling and processing of blood specimens (NCCLS H18-A3) already in place, this guideline will not include these aspects of patient sample collection and handling already addressed in these two guidelines.  This guideline will include the storage and handling procedures for the specimen once the sample has been processed (following the recommendations from NCCLS H3-A5 & NCCLS H18-A3) to the serum and/or plasma matrix.  This document will provide recommendations on procedures that should be performed to characterize analyte stability in a serum and/or plasma matrix.  The guideline will provide recommendations for serum and plasma samples, and will also highlight the difficulties and concerns for using other matrices such as urine (precipitation) if extending stability studies to these matrices. The document will provide guidelines for establishing sample stability testing designs, and it will also attempt to describe procedures that may not be published elsewhere. 

The document will consist of three parts. The first part will address the characteristics and specifications for storage containers to be used for sample stability studies.  The second part will address issues related to the procedural design for undertaking sample stability studies for individual or grouped analytes.  The third part will address the clinical basis and statistical analysis for determining unacceptable drift in analyte concentration over time.

Specific Expertise/Work Experience Needed:
Knowledge and expertise (as demonstrated by peer-reviewed published works) on the validation of body fluid handling and storage procedures to ensure sample integrity.  Further, knowledge and experience in statistical analysis and clinical relevance.

Review the objective of the project, and the requested volunteer expertise, and submit a nomination.

The deadline to submit the nominations, including a curriculum vitae and disclosure of interests form, is 18 October 2006.  Send to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087. [ return to top ]