Viable mononuclear cell stability study for implementation in a proficiency testing program: impact of shipment conditions.

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.

DNA fingerprinting: a quality control case study for human biospecimen authentication.

This case study illustrates the usefulness of the DNA fingerprinting method in biobank quality control (QC) procedures and emphasizes the need for detailed and accurate record keeping during processing of biological samples. It also underlines the value of independent third-party assessment to identify points at which errors are most likely to have occurred when unexpected results are obtained from biospecimens.

Lithostatine concentration is not useful for assessing the preanalytical variations in biobanked urine samples.

Proteomic research requires high-quality, standardized samples. Quality control (QC) biomarkers, which are sensitive to the collection, processing or storage conditions, would be useful tools to identify compromised samples. This study evaluates the usefulness of renal lithostatine as a QC tool for urine sample processing in daily biobank work. Four factors (pre-analytical variations) were examined for their effect on renal lithostatine as measured by ELISA: time from sample collection to centrifugation, number of specimen freeze-thaw cycles, specimen preservation with protease inhibitors, and the inclusion or exclusion of urinary sediment.

Identification of evidence-based biospecimen quality-control tools: a report of the International Society for Biological and Environmental Repositories (ISBER) Biospecimen Science Working Group.

Control of biospecimen quality that is linked to processing is one of the goals of biospecimen science. Consensus is lacking, however, regarding optimal sample quality-control (QC) tools (ie, markers and assays). The aim of this review was to identify QC tools, both for fluid and solid-tissue samples, based on a comprehensive and critical literature review. The most readily applicable tools are those with a known threshold for the preanalytical variation and a known reference range for the QC analyte. Only a few meaningful markers were identified that meet these criteria, such as CD40L for assessing serum exposure at high temperatures and VEGF for assessing serum freeze-thawing. To fully assess biospecimen quality, multiple QC markers are needed. Here we present the most promising biospecimen QC tools that were identified.

SPRECware: software tools for Standard PREanalytical Code (SPREC) labeling - effective exchange and search of stored biospecimens.

Biobanks provide stored material to basic, translational, and epidemiological research and this material should be transferred without institute-dependent intrinsic bias. The ISBER Biospecimen Science Working Group has released a "Standard PREanalytical Code" (SPREC), which is a proposal for a standard coding of the preanalytical options that have been adopted in order to track and make explicit the preanalytical variations in the collection, preparation, and storage of specimens. In this paper we address 2 issues arising in any biobank or biolaboratory aiming at adopting SPREC: (i) reducing the burden required to adopt this standard coding, and (ii) maximize the immediate benefits of this adoption by providing a free, dedicated software tool. We propose SPRECware, a vision encompassing tools and solutions for the best exploitation of SPREC based on information technology (www.sprecware.org). As a first step, we make available SPRECbase, a software tool useful for generating, storing, managing, and exchanging SPREC-related information associated to specimens. Adopting SPREC is useful both for internal purposes (such as finding the samples having some given preanalytical features), and for exchanging the preanalytical information associated to biological samples between Laboratory Information Systems. In case of a common adoption of this coding, it would be easy to find out whether and where, among the participating Biological Resource Centers, the specimens for a given study are available in order to carry out a planned experiment.

Validation of free flow electrophoresis as a novel plasma and serum processing and fractionation method in biobanking.

Free flow electrophoresis (FFE) is a fractionation method, based on isoelectric focusing (IEF). We validate the reproducibility of the method and show that it can be applied by biobanks in order to fractionate fluid biospecimens efficiently and reproducibly and to facilitate downstream proteomic applications. We also propose a simple method allowing researchers to assess the reproducibility of each FFE run.

Standard preanalytical coding for biospecimens: review and implementation of the Sample PREanalytical Code (SPREC).

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.

A Pilot Study of the ELFE Longitudinal Cohort: Feasibility and Preliminary Evaluation of Biological Collection.

Etude Longitudinale Française depuis l'Enfance (ELFE) will be a national French cohort of 20,000 children followed from birth to adulthood. Biological samples will be taken at birth to evaluate the fetal exposition to several substances. A pilot study was carried out in October 2007 to test the preanalytical factors that affected sample quality. A variety of fractions were collected by the midwife after delivery from different blood collection tubes. Options in the collection process were 2 daily transports of samples, centralized and standardized processing methodology, and storage of multiple aliquots in liquid nitrogen or at -80°C. We analyzed preanalytical factors that could have affected coagulation and then soluble CD40 Ligand (sCD40L) as a quality control tool for serum quality. Cord blood and urine were collected from 82% and 84% of women, respectively, who agreed to be followed up in the ELFE project. The use of syringe was the main factor correlated with coagulation (relative risk: 2.79 [1.47; 5.31], P<0.01). Maternity unit status was also associated with coagulation (RR: 1.48 [1.03; 2.13] in a private maternity unit vs. a public maternity) as well as time between collection and centrifugation (RR 1.03 [1; 1.07] when time between collection and centrifugation increases from 1 h). There were no extremely low sCD40L values indicating extreme exposures to room temperatures. This first evaluation study allowed us to stress the importance of carefully recording all potentially critical preanalytical variables that might be used at a large-scale level.

Influence of common preanalytical variations on the metabolic profile of serum samples in biobanks.

A blood pre-centrifugation delay of 24 h at room temperature influenced the proton NMR spectroscopic profiles of human serum. A blood pre-centrifugation delay of 24 h at 4°C did not influence the spectroscopic profile as compared with 4 h delays at either room temperature or 4°C. Five or ten serum freeze-thaw cycles also influenced the proton NMR spectroscopic profiles. Certain common in vitro preanalytical variations occurring in biobanks may impact the metabolic profile of human serum.

Infectious diseases biobanking as a catalyst towards personalized medicine: Mycobacterium tuberculosis paradigm.

Research for biomarkers supporting personalized medicine in infectious diseases is needed, especially for tuberculosis in which the existing toolbox does not yet address the public health priorities. Biobanks are essential infrastructures in this effort by collecting, authenticating and preserving human and/or bacterial specimens. A broad range of specimens should be collected prior to, during and following treatment, with a comprehensive characterisation of the sample donors and the samples themselves to accommodate the most recent technological platforms in biomarker research. This review explains current state-of-the-field biobanking practices in tuberculosis and suggests technical and managerial improvements to ensure long-term preservation and optimal use of the specimens. Open-access and certified biobanks are an essential component of a strategy supporting the development of drugs and diagnostic tests for both public health and personalised medicine. Biobanks have a role to play in the interaction between these two - not always compatible - approaches.

Standard PREanalytical Codes: A New Paradigm for Environmental Biobanking Sectors Explored in Algal Culture Collections.

The Standard PREanalytical Code (SPREC) was developed by the medical/clinical biobanking sector motivated by the need to harmonize biospecimen traceability in preanalytical processes and enable interconnectivity and interoperability between different biobanks, research consortia, and infrastructures. The clinical SPREC (01) consists of standard preanalytical variable options (7-code elements), which comprise published and (ideally) validated methodologies. Although the SPREC has been designed to facilitate clinical research, the concept could have utility in biorepositories and culture collections that service environmental and biodiversity communities. The SPREC paradigm can be applied to different storage regimes across all types of biorepository. The objective of this article is to investigate adapting the code in nonclinical biobanks using algal culture collections and their cryostorage as a case study. The SPREC (01) is recalibrated as a putative code that might be adopted for biobanks holding different types of biodiversity; it is extended to include optional coding from the point of sample collection to postcryostorage manipulations, with the caveat that the processes are undertaken by biorepository personnel.

Quality assurance in cancer biobanking.

Biobanking is recognized as a critical area requiring development if progress is to be made in identifying clinically useful markers of disease and disease progression, discovering new drug targets, and understanding the mechanisms of disease in cancer. Researchers continue to report that they are unable to obtain sufficient high-quality, well-annotated samples of diseased and control tissue, blood, and other biological materials. At the same time, funders of research, and especially funders of biobanks, are looking to obtain the best value from their investments in sample and data collection. There is a need to increase the availability to researchers of large numbers of high-quality, well-annotated samples of diseased and control tissue, blood, and other biological materials and, in this way, accelerate cancer research. To do this, samples need to be collected, processed, and stored in standardized ways that give assurance to researchers that they are fit for purpose. Quality assurance is an essential part of good science and this article describes how quality assurance is applied in cancer biobanking and discusses the need for internationally acceptable standards.

Standard preanalytical coding for biospecimens: defining the sample PREanalytical code.

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.

Immunological fingerprinting method for differentiation of serum samples in research-oriented biobanks.

An immunoenzymatic serum fingerprinting method was developed to establish a serum sample fingerprint based on IgG titers obtained with three different antigens. Three widely expressed antigens were selected for their capacity to induce long-lasting humoral immune responses. This fingerprinting method may be used to differentiate between two serum samples and to determine whether they come from the same primary blood specimen. The method showed a specificity of 99.5%. This method is suitable as a quality control method for biobanked serum samples.

Soluble CD40 ligand as a biomarker for storage-related preanalytic variations of human serum.

There are currently no appropriate and sensitive biomarkers available to assess preanalytic variations in human biological fluids stored in biobanks. We identified soluble CD40 ligand (sCD40L) as the first ubiquitous biomarker to show an on-off response in serum exposed to moderate or elevated room temperature conditions. We used immunoenzyme assays to monitor the sCD40L response after 12 h storage at 37 degrees C or 48 h at 20 degrees C. Our findings show that prolonged storage of serum samples at elevated room temperature can be determined by the absence of detectable sCD40L.

Serological profiling with Chlamycheck, a commercial multiplex recombinant antigen Western blot assay of chlamydial infections.

A new chlamydial test system, the Chlamycheck assay, which uses 4 purified recombinant antigens of Chlamydia trachomatis and Chlamydophila pneumoniae and one antigen of Chlamydophila psittaci, has been developed and commercialized. We investigated the reactivities of the recombinant antigens with sera from a group of 30 patients with acute Chlamydia trachomatis infection, 88 patients consulting for sexually transmitted infections, and 46 patients with serological evidence of Chlamydophila pneumoniae infection. The results obtained from human and infected mouse sera suggest that Chlamycheck serology against multiple proteins may provide additional useful information that is not available by conventional whole elementary body microimmunofluorescence or single-antigen enzyme-linked immunosorbent assay serology. Specific serological profiles were associated with acute versus past Chlamydia trachomatis infection or with Chlamydia trachomatis primo-infection versus infection in a Chlamydophila pneumoniae history context.