The impact of shipping temperatures and preservation media used during transport of either peripheral blood mononuclear cells (PBMCs) or Jurkat cells was assessed, in view of implementing of a proficiency testing scheme on mononuclear cell viability. Samples were analyzed before and after shipment at different temperatures (ambient temperature, dry ice, and liquid nitrogen) and in different preservation media (serum with cryoprotectant, commercial cryopreservation solution, and room temperature transport medium). Sample quality was assessed by viability assays (Trypan Blue dye exclusion, flow cytometry, Cell Analysis System cell counting (CASY)), and by ELISpot functional assay. The liquid nitrogen storage and shipment were found to be the most stable conditions to preserve cell viability and functionality. However, we show that alternative high quality shipment conditions for viable cells are dry ice shipment and commercial cryopreservation solution. These were also cost-efficient shipment conditions, satisfying the requirements of a proficiency testing scheme for viable mononuclear cells. Room temperature transport medium dramatically and adversely affected the integrity of mononuclear cells.

The first version of the Standard PREanalytical Code (SPREC) was developed in 2009 by the International Society for Biological and Environmental Repositories (ISBER) Biospecimen Science Working Group to facilitate documentation and communication of the most important preanalytical quality parameters of different types of biospecimens used for research. This same Working Group has now updated the SPREC to version 2.0, presented here, so that it contains more options to allow for recent technological developments. Existing elements have been fine tuned. An interface to the Biospecimen Reporting for Improved Study Quality (BRISQ) has been defined, and informatics solutions for SPREC implementation have been developed. A glossary with SPREC-related definitions has also been added.

Until now, proficiency testing programs have not existed for the quality assessment of biospecimens that are used in basic, translational, and clinical research studies, yet the discovery, validation, and clinical evaluation of biomarkers necessary for the advancement of global health depend upon the availability of a large number of standardized specimens. To meet this void, ISBER has launched a biorepository Proficiency Testing (PT) Program in partnership with the Integrated Biobank of Luxembourg (IBBL). The ISBER PT Program belongs to the category of interlaboratory comparison ‘‘schemes’’ involving simultaneous participation of biorepository laboratories located in different countries. Randomly selected aliquots from a source material prepared at IBBL (the test items) are being distributed and tested concurrently by all registered participants. After the completion of the testing, the participants’ results will be returned to the Proficiency Testing provider (ISBER) and compared with the assigned value(s) derived from the reference laboratories to give an indication of the performance of the individual participants and of the group as a whole. The ISBER PT Program allows biorepositories performing quality control assays and/or characterization of the biospecimens to assess the accuracy of their testing and to compare their results with those obtained in other laboratories around the world. It has been designed to include four schemes: DNA quantification and purity, RNA integrity, cell viability, and tissue antigenicity. The first two schemes were open for participation in the latter part of 2011. The cell viability and tissue antigenicity schemes will be added to the program in 2012.

uthors' A nstitute o esearch ilmslow ospital M esearch S ingdom, alifornia, alifornia; Quintiles ultidiscip dvanced cientifico Rome “La Rome, Ita Cancer Ep Background: Management and traceability of biospecimen preanalytical variations are necessary to provide effective and efficient interconnectivity and interoperability between Biobanks. Methods: Therefore, the International Society for Biological and Environmental Repositories Biospecimen Science Working Group developed a “Standard PREanalytical Code” (SPREC) that identifies the main preanalytical factors of clinical fluid and solid biospecimens and their simple derivatives. Results: The SPREC is easy to implement and can be integrated into Biobank quality management systems and databases. It can also be extended to nonhuman biorepository areas. Its flexibility allows integration of new novel technological developments in future versions. SPREC version 01 is presented in this article. Conclusions and Impact: Implementation of the SPREC is expected to facilitate and consolidate international multicenter biomarker identification research and biospecimen research in the clinical Biobank environment. Cancer Epidemiol Biomarkers Prev; 19(4); 1004–11. ©2010 AACR.

BACKGROUND:Management and traceability of biospecimen preanalytical variations are necessary to provide effective and efficient interconnectivity and interoperability between Biobanks. METHODS:Therefore, the International Society for Biological and Environmental Repositories Biospecimen Science Working Group developed a "Standard PREanalytical Code" (SPREC) that identifies the main preanalytical factors of clinical fluid and solid biospecimens and their simple derivatives. RESULTS:The SPREC is easy to implement and can be integrated into Biobank quality management systems and databases. It can also be extended to nonhuman biorepository areas. Its flexibility allows integration of new novel technological developments in future versions. SPREC version 01 is presented in this article. CONCLUSIONS AND IMPACT:Implementation of the SPREC is expected to facilitate and consolidate international multicenter biomarker identification research and biospecimen research in the clinical Biobank environment.

uthors' A nstitute o esearch ilmslow ospital M esearch S ingdom, alifornia, alifornia; Quintiles ultidiscip dvanced cientifico Rome “La Rome, Ita

Among the different types of variability (interindividual, intra-individual, analytical, and preanalytical) that can influence the results of any biological assay, preanalytical variations are the most difficult to manage. Preanalytical variations are defined as any variation taking place between