Specimen Collection
The Biofluids Repository Core (BRC) follows standardized, CAP-aligned workflows designed to ensure biospecimen integrity, traceability, and regulatory compliance across the full lifecycle of collection, processing, storage, and distribution. All protocols are optimized in coordination with study teams and, when applicable, integrated with the Human Tissue Acquisition and Pathology (HTAP) Core to support end-to-end biobanking.
Specimen Collection and Consenting
The BRC supports investigator-initiated and centrally coordinated specimen collection models. In collaboration with clinical teams and HTAP, BRC-affiliated clinical coordinators can assist with participant identification, consenting, and biospecimen collection under approved IRB protocols. Alternatively, specimens collected by study teams may be transferred to the BRC under defined chain-of-custody procedures.
Collected specimens are transported under controlled conditions to BRC processing laboratories for stanardized handling and downstream processing.
Sample Processing and Quality Control
BRC laboratories are equipped with validated, automated, and semi-automated systems to ensure reproducible and standardized biospecimen processing. Processing workflows are governed by SOPs within a CAP-accredited quality management framework and include:
- Controlled centrifugation and fractionation
- Automated and manual aliquoting
- Temperature-controlled processing environments
- Documentation of pre-analytical variables
- Quality checks and release criteria prior to storage or distribution
All parent and derivative specimens are barcoded and tracked in a centralized laboratory information management system (LIMS) to ensure full traceability and audit readiness.
Specimen Types Supported
Biofluids
- Whole blood
- Plasma
- Serum
- Buffy coat
- PBMCs
- Urine
- Stool
- Saliva
- Cerebrospinal fluid (CSF)
- Bronchoalveolar lavage (BAL)
- Specialized clinical and cardiovascular biofluids
Nucleic Acids & Derivatives
- DNA
- RNA
- Cell-free nucleic acids
- Exosomes and extracellular vesicles
Separation, Aliquoting and Derivative Generation
Standardized separation and aliquoting workflows are tailored to study-specific requirements and downstream applications, including:
- Plasma and serum fractionation
- Cellular component isolation (e.g., buffy coat, PBMCs)
- DNA and RNA extraction
- Exosome isolation
- Customized aliquot sizing and labeling
All derivatives are generated under documented SOPs and linked to parent specimens within the LIMS.
Storage, Inventory and Distribution
Specimens are stored in continuously monitored -80 °C freezers and liquid nitrogen vapor-phase systems, with automated temperature tracking, alarm notifications, and backup safeguards. Inventory is managed centrally to enable real-time tracking, reporting, and controlled release for approved studies.
Specimen distribution follows defined approval workflows and maintains complete chain-of-custody documentation.”
