CLSI EP50 Volunteer Application

CLSI EP50 | Evaluation of Stability for Venous Whole Blood and Blood Derived Samples,1st Edition

CLSI EP50 will include prospective study designs, experimental protocols, data analysis, and acceptance criteria for freshly collected whole blood specimens, as well as serum and plasma, used for in vitro medical laboratory device testing. While the emphasis is on human blood specimens and samples, many of the concepts may be applicable to other types of human specimens.

This standard covers:

• Patient specimen collection, preservation, and transport
• Procedures for detecting mycobacteria directly in specimens using microscopy and amplification techniques
• Optimal recovery of mycobacteria from patient specimens
• Identification of mycobacterial species by phenotypic and genotypic laboratory methods 

We are specifically looking for volunteers with:

• Expertise in validation sample validation stability studies

   

• Expertise in verification sample stability studies

   

• Expertise in the statistical analysis of sample validation and verification studies

Estimated Timeline 

• Week of 22-28 February 2026: First meeting (may include review of document scope and outline, assignment of writing teams)
• February 2026 to May 2027: Drafting of document (higher-intensity volunteer time period)
• July 2027 to August 2027: Voting period for draft document
• August 2027 to October 2027: Revision of draft based on comments received during voting 
• March 2028: Expected Final Draft approval date

Apply on or before 27 January 2026.