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

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.

Figure 1

Quality control assays, applied on biological samples, can be either diagnostic of upstream collection, processing, and/or storage conditions or predictive of the feasibility and/or validity of downstream analysis performed with the samples.

Figure 2

Biospecimen science literature compilation of human biospecimen science studies in a clinical (A) or a research (B) setting. Asterisks mark groups of publications reviewed for this study.

Figure 3

Models of QC tools. Baseline reference ranges are indicated as mean values in the population (blue diamonds) and as upper (red diamonds) and lower (green diamonds) reference values. The (shaded area) red squares corresponds to an arbitrary threshold of the QC marker below which diagnostic conclusions as to the upstream processing of the sample can be drawn. A: Linear degradation of the QC marker. B: Exponential degradation of the QC marker. AU, arbitrary units.