The Impact of Preanalytical Procedures on Biospecimen Quality

The Impact of Preanalytical Procedures on Biospecimen Quality
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Successful research depends on high-quality biospecimens. Many researchers rely on biobanks to supply fit-for-purpose samples to support their clinical, translational, and biomedical studies. Biobanks and biorepositories play a critical role in modern genomics research by providing scientists with high-quality and precisely annotated biospecimens1.

Biobanks and researchers can use sample quality control (QC) to assess the quality of their biospecimens. Sample QC provides objective information about nucleic acid size, quantity, and quality. Quality metrics such as DNA integrity number (DIN) for genomic DNA, percent cell-free DNA (%cfDNA), RNA integrity number (RIN/RINe), RNA quality number (RQN), and distribution value 200 (DV200) can be used to identify which samples are suited for specific studies. They can also be used to determine which samples are best for downstream applications, including microarray analysis or next-generation sequencing (NGS). Because significantly degraded biospecimens can lead to poor results, they can be identified through sample QC and be replaced with more suitable specimens.

Researchers often use sample QC in their genomics workflows since certain specimen types are more susceptible to DNA and RNA degradation. Nucleic acid fragmentation can be induced by chemical fixative type, fixation time, and the use of different extraction methods.2 In addition, variability in a biobank’s preanalytical procedures such as sample collection, processing, storage, and shipping, can negatively impact the quality of biospecimens. Variable specimen quality may further lead to irreproducible and unreliable study data. By testing sample quality, biobank personnel get the information they and their collaborators need, including objective insights for reliable decisions on next steps.

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Aligning preanalytical procedures such as those used in sample collection, processing, storage, and shipping can positively influence nucleic acid integrity. Using objective quality metrics in benchmarking studies and side-by-side process comparisons can deliver unbiased results that enable biobanks to determine optimal operating parameters. These parameters and procedures can then be added to the biobank’s list of best practices for internal standardization.

To help standardize biorepository preanalytical procedures across the industry, the International Standards Organization (ISO), the International Society for Biological and Environmental Repositories (ISBER), and the Standardization Administration of China (SAC) have published standards and guidance documents. ISO standard 20387:2018 recommends that biobanks establish, document, and implement QC procedures.3 The standard also guides biorepositories to provide objective evidence for these QC activities.2 ISBER built their guidance upon four pillars of collection quality, which include authenticity, purity, stability, and consent.4 Two of those pillars, purity and stability, highlight the need for assessing the integrity of nucleic acid fragments.4

Biorepository standards and guidelines for preanalytical procedures, as determined through sample quality control testing, can help biobanks and biorepositories identify and reinforce their facility’s best practices. They can also ensure that researchers get consistent and fit-for-purpose samples that, in turn, help deliver reproducible and reliable study data.



1. Agilent Technologies. Agilent SLIMS for Biobanks; 2021. Brochure, 5994-3563EN.
2. Agilent Technologies. Quality Control of Nucleic Acids: Best Practices for Biobanks and Biorepositories; 2021. Application Note, 5994-3143EN.
3. International Standards Organization ISO 20387 Biotechnology – Biobanking – General requirements for biobanking. First Ed. 2018.
4. ISBER Best Practices: Recommendations for Repositories Fourth Ed. 2018.