Background: Longer pre-centrifugation times alter the quality of serum and plasma samples. Markers for such delays in sample processing and hence for the sample quality, have been identified. Methods: Twenty cytokines in serum, EDTA plasma and citrate plasma samples were screened for changes in concentration induced by extended blood pre-centrifugation delays at room temperature. The two cytokines that showed the largest changes were further validated for their " diagnostic performance" in identifying serum or plasma samples with extended pre-centrifugation times. Results: In this study, using R& D Systems ELISA kits, EDTA plasma samples and serum samples with a pre-centrifugation delay longer than 24 h had an IL16 concentration higher than 313 pg/mL, and an IL8 concentration higher than 125 pg/mL, respectively. EDTA plasma samples with a pre-centrifugation delay longer than 48 h had an IL16 concentration higher than 897 pg/mL, citrate plasma samples had an IL8 concentration higher than 21.5 pg/mL and serum samples had an IL8 concentration higher than 528 pg/mL. Conclusions: These robust and accurate tools, based on simple and commercially available ELISA assays can greatly facilitate qualification of serum and plasma legacy collections with undocumented pre-analytics.

Background: Uncontrolled preanalytical variables can reduce the accuracy and reproducibility of downstream analytical results from peripheral blood mononuclear cells (PBMCs). Methods: PBMCs were isolated from EDTA and citrate-anticoagulated blood samples, obtained from healthy subjects and patients with inflammatory and infectious conditions. PBMC-derived RNA samples were examined for gene expression changes induced by extended blood pre-centrifugation delays at 4 degrees C and RT. We used Taqman RTqPCR to evaluate the combination of two target genes for their "diagnostic performance" in identifying EDTA and citrate-anticoagulated PBMC samples with extended pre-centrifugation times. Results: We established the PBMC preanalytical score, a gene expression metric to asses the PBMC quality related to the pre-centrifugation delay at room temperature for different anticoagulants. The PBMC preanalytical score measurement can identify: (1) EDTA PBMC samples or RNA extracted from these PBMCs with RT precentrifugation times > 48 h with 98% sensitivity and 87% specificity at a cutoff of 57. (2) citrate PBMC samples or RNA extracted from these PBMCs with RT precentrifugation times of > 48 h with 92% sensitivity and 84% specificity at a cutoff of 348. Conclusion: The proposed PBMC preanalytical score may enable objective PBMC sample qualification for downstream applications, which may be influenced by blood precentrifugation delays.

The College of American Pathologists (CAP) developed the Biorepository Accreditation Program (BAP) in 2012. This program integrates best practices from the International Society for Biological and Environmental Biorepositories, the National Cancer Institute, the Organisation for Economic Cooperation and Development, the Center for Medicare and Medicaid Services, and the CAP Laboratory Accreditation Program. The goal of this elective program is to provide requirements for standardization in biorepository processes that will result in high-quality specimens that can be used to support research, drug discovery, and personalized medicine. CAP uses a peer inspection model to ensure the inspectors have proper expertise and to promote educational efforts through information sharing. Lead inspectors are comprised of pathologists, PhDs, and managers of biorepositories and they are often supported by CAP staff inspectors. Accreditation is a 3-year continuous cycle of quality with a peer inspection occurring at the start of year 1 and a self-inspection and CAP desk assessment at the start of year 2 and 3. At this time 53 biorepositories are fully CAP BAP accredited and 13 are in the process of obtaining accreditation. There are currently 273 established standards with requirement lists customized based on the scope of activities performed by a biorepository. A total of 90 inspections were completed between May 2012 and December 2016. Sixty-one were initial inspections and 29 were reinspections. A total of 527 deficiencies were identified in the areas of Equipment/Instrumentation (22%), Information Technology (18%), Specimen Handling and QC (15%), Quality Management (16%), Personnel (11%), Safety (10%), Facilities (6%), and Regulatory (2%). Assessment of common deficiencies identifies areas of focus for continuous improvement and educational opportunities. Overall success of the program is high based on the current enrollment of 66 biorepositories, anecdotal participant feedback and increasing national recognition of the BAP in federal documents.

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.

Differences in biorepository methods and practices can result in sample variation that has the potential to impact research results derived from those samples. The establishment of common quality assurance (QA) and quality control (QC) tools has been difficult due to the wide variety of specimens and intended uses of the collections in biorepositories. The development and adoption of the ISBER Best Practices for Repositories (Best Practices), the latest edition of which was published in Biopreservation and Biobanking this past April, has been an important advancement in the field. Best Practices provides guidance on management practices and technical aspects, and addresses repository development, facilities and equipment, cost management, security, and training, while taking regulatory compliance and the ethical, legal, and social issues relevant to repositories into account. Although many biorepository institutions have adopted these Best Practices, dissemination of information on sample preparation methods and sample quality assessment practices across biorepositories remains a significant issue for the repository community. External quality assurance (EQA) programs are utilized throughout the world to control interlaboratory variation in the clinical diagnostic arena and are excellent models to apply for standardization of key quality assessment processes in the biorepository industry.

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.

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Cell Preservation TechnologyVol. 3, No. 1 Best Practices for Repositories IBest Practices for Repositories I: Collection, Storage, and Retrieval of Human Biological Materials for ResearchInternational Society for Biological and Environmental Repositories (ISBER)International Society for Biological and Environmental Repositories (ISBER)Search for more papers by this authorPublished Online:12 Apr 2005https://doi.org/10.1089/cpt.2005.3.5AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byBiobanking for Neurodegenerative Diseases: Challenge for Translational Research and Data Privacy5 August 2021 | The Neuroscientist, Vol. 29, No. 2Blockchain technology: a troubleshooter for blood cold chains26 April 2022 | Journal of Global Operations and Strategic Sourcing, Vol. 15, No. 3Vitrification Ability of Combined and Single Cryoprotective Agents6 November 2021 | Plants, Vol. 10, No. 11National Biobank Networking: The Case of Spain26 August 2021Obtaining High-Quality Blood Specimens for Downstream Applications: A Review of Current Knowledge and Best Practices Qiyuan Li, Xian Wang, Xue Li, Xuheng He, Qian Wan, Jiefang Yin, Jianbo Sun, Xiaoping Yang, Qiaohong Chen, and Xinyuan Miao17 December 2018 | Biopreservation and Biobanking, Vol. 16, No. 6ISBER President's Message: The Intent of the ISBER Best Practices Fourth Edition Zisis Kozlakidis1 February 2018 | Biopreservation and Biobanking, Vol. 16, No. 1Banking brain tissue for researchManagement of Patient SamplesEthical Legal and Social Issues of Biobanking: Past, Present, and Future Marianna J. 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Ryan Gregory1 August 2007 | Cell Preservation Technology, Vol. 5, No. 2Comparison of a Selection of Rapid Automated DNA and RNA Extraction Technologies for Detection of Somatic or Constitutional Gene Abnormalities in Cancer Diagnosis François Lassailly, Marie-Joëlle Mozziconacci, Tetsuro Noguchi, Didier Bechlian, José Adelaide, Frédéric Fina, Pierre-Marie Martin, Hagay Sobol, Luc Xerri, Daniel Birnbaum, and Christian Chabannon23 April 2007 | Cell Preservation Technology, Vol. 5, No. 1Providing Human Tissue for Research: 1996–200624 August 2007 | Pathobiology, Vol. 74, No. 4Tumour Banking: The Spanish Design24 August 2007 | Pathobiology, Vol. 74, No. 4An informatics model for tissue banks – Lessons learned from the Cooperative Prostate Cancer Tissue Resource5 May 2006 | BMC Cancer, Vol. 6, No. 1Blood Collection, Shipment, Processing, and Storage19 September 2006 | Cancer Epidemiology, Biomarkers & Prevention, Vol. 15, No. 9Biorepository and Biospecimen Science: A New Focus for CEBP19 September 2006 | Cancer Epidemiology, Biomarkers & Prevention, Vol. 15, No. 9 Volume 3Issue 1Mar 2005 InformationCopyright 2005, Mary Ann Liebert, Inc.To cite this article:International Society for Biological and Environmental Repositories (ISBER).Best Practices for Repositories I: Collection, Storage, and Retrieval of Human Biological Materials for Research.Cell Preservation Technology.Mar 2005.5-48.http://doi.org/10.1089/cpt.2005.3.5Published in Volume: 3 Issue 1: April 12, 2005PDF download