Article

Standard Operating Procedures for Serum and Plasma Collection: Early Detection Research Network Consensus Statement Standard Operating Procedure Integration Working Group

Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan 48109-0725, USA.
Journal of Proteome Research (Impact Factor: 5). 01/2009; 8(1):113-7. DOI: 10.1021/pr800545q
Source: PubMed

ABSTRACT Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation.

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    • "Briefly, it is collected from thousands of healthy donors, randomized, standardized and specially prepared according to Clinical Laboratory Improvement Amendments certification procedure approved by FDA (Tuck et al., 2009). Finally, it is provided in dried lyophilized powder (Tuck et al., 2009). The standardized serum can be used in different clinical research studies (Ipp & Gold, 1988; Uchida et al., 2014). "
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