Identification of Evidence-Based Biospecimen Quality-Control Tools

Abstract

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.

Evaluating the effects of preanalytical variables on the stability of the human plasma proteome

“…Several organizations provide best practices guidelines covering various aspects of the biospecimen lifecycle [9,11,44,45]. The International Society for Biological and Environmental Repositories (ISBER) recently compiled the literature concerning potential plasma/serum protein markers for preanalytical variation assessment; the bulk were single analytes measured by using immunoassays [46]. The National Cancer Institute established the Biorepositories and Biospecimen Research Branch, which recently published evidence-based guidance for the snap freezing of human tissue biospecimens [47].…”

Combined Effect of Tissue Stabilization and Protein Extraction Methods on Phosphoprotein Analysis

“…Exploiting phosphoproteins as quality control tools for tissue specimens has already been suggested. 7 However, further studies are needed, particularly in tissue types other than brain, to assess the more general utility of such quality control tools. Further studies on development of novel phosphoprotein extraction methods from tissues could also improve the reliability of phosphoprotein analysis for new clinically relevant biomarkers.…”

“…Therefore, there is a need for protocol quality control and reduction of pre-analytical variability in tissue samples, thereby providing high quality tissue specimens, which are fit-for-purpose for both histological and biomolecular analyses. 7 A general rule in tissue processing is the faster the tissue fixation, the closer the quality of the tissue sample to its in vivo state. Formaldehyde is the gold standard of fixatives for routine histology and immunohistochemistry (IHC).…”

Enhancing translational research in paediatric rheumatology through standardization

“…29 Development and testing of various QC measures for biospecimens is in its infancy. ISBER endorsed a review of the literature, 30 summarizing existing research on QC measures (preprocessing delay, freeze thawing, storage conditions) and assessing potential evidence-based QC assays summarizing potential QC biomarkers. CD40L and VEGF were identified as potentially meaningful analytes for assessing serum exposure to variations in temperatures for assessing serum freeze-thawing.…”

“…CD40L and VEGF were identified as potentially meaningful analytes for assessing serum exposure to variations in temperatures for assessing serum freeze-thawing. 30 However a caveat was that soluble CD40L levels are already artificially elevated in serum samples (which are not platelet free), and the increased sCD40L concentrations are a result of ex-vivo platelet activation during sample preparation and not due to in-vivo factors, therefore interpretation of studies of sCD40L already require caution. 31 Ascorbic acid has also been used as a QC marker for blood pre-centrifugation delay and serum storage conditions owing to its intrinsic instability.…”