.svg){kind=small}
Biospecimens, Base Matrices and Bulk Biologicals
Understanding biospecimens: What are biospecimens?
A biospecimen (biological specimen) is a sample of biological material such as blood, plasma, serum, urine, saliva, cerebrospinal fluid and beyond. These biological samples may be taken from humans, animals or plants, and may be used in laboratory testing or stored in a ‘library’ called a biorepository (or biobank) and used in research.1
View Medix Biochemica Biospecimens, Base Matrices, & Bulk Biologicals Catalog
The importance of biospecimens
Biological specimen research plays a critical role in understanding and improving human health conditions.2 Human-derived biospecimens can provide a bridge between emerging molecular information and clinical information. Researchers use biospecimens to isolate the molecular characteristics of a human disease, and correlate these patterns with what they know about how that disease progresses.3
Human specimens are typically used to:
- Identify and validate methods of delivering drugs or agents to specific cells3
- Identify how diseases (e.g. cancer) progress and vary3
- Classify patients as more or less likely to respond to specific drugs3
- Classify patients to determine which treatment is appropriate3
- Develop screening tests to detect biomarkers associated with certain stages or subtypes of a disease3
- Identify, translate and validate new biomarkers4
Validate and Control Your Assay with Medix Biochemica’s Comprehensive Selection of Biospecimens
Understanding the importance of biospecimens in in vitro diagnostics:
Biospecimens are indispensable in advancing our understanding of disease and improving testing to promote human health through accurate results. By bridging academic discoveries with clinical insights through improved testing, researchers are able to uncover the underlying characteristics of diseases and correlate them with their disease progression. Human biospecimens are fundamental to enabling improved diagnostics and ultimately informing better healthcare decisions.
In the IVD space, biospecimens are typically used in several key areas:
- Research: Biospecimens aid in identifying markers and validating tests, bridging early-stage research to final, reliable results.
- Creating tests (assay development): Biospecimens assess test functionality, adjust conditions, and set standard ranges. Proper handling ensures reliable results.
- Confirming test accuracy (assay validation): Biospecimens confirm test precision, accuracy, and consistency, defining limits and supporting regulatory approval.
- Quality control materials: Biospecimens act as quality controls, providing a standard for comparison and ensuring tests work as intended.
| “Biospecimens contain an extraordinary amount of biological information written in the language of cells, genes and proteins. They provide important insights into individual variabilities that might influence health.” - National Cancer Institute Biorepositories and Biospecimen Research Branch5 |
Researchers are always in need of biospecimen donors, especially those from underrepresented population groups.5
The importance of control in biospecimen collection and storage conditions
The biospecimens that researchers work with need to be of a consistently high quality.6,7 Because biological specimens can degrade over time and this instability can cause inaccurate analysis of the specimen’s characteristics,7 extreme care must be taken at every stage of collecting, storing and distributing biospecimens to maintain their integrity. The National Cancer Institute’s Biorepositories and Biospecimen Research Branch defines a high-quality biospecimen as one “whose biology most closely resembles the biology of the biospecimen prior to its removal from the human research participant.”7 A robust quality management system must therefore be in place.6
Types of biospecimen collection: Prospective and Retrospective
Prospective Collection8,9
Prospective collection refers to the active acquisition of biospecimens from donors, which is often needed when a fresh sample is required or when specific specimens are not available in existing biorepositories. This situation may arise due to the rarity of the sample or disease being studied, or because the available samples do not meet the required criteria for the user. Prospective collections often allow for access to recallable donors with ample data, as well as allowing for flexibility in collection protocols and devices.
There are two main types of prospective biological specimen collections:
- Ongoing prospective collection: In this scenario, Institutional Review Board (IRB) approval for a general collection protocol is already in place, and samples are being collected continuously. These specimens are made available to various researchers and organizations for different types of studies and applications.
Read more: The Role of Institutional Review Boards in Upholding Ethical Biospecimen Practices.
- Custom prospective collection: This is available when specific collection parameters or donor protocols must be met. This is often necessary when certain demographics, disease states or protocols must be followed to address the experimental aims of the researchers conducting the study.
Retrospective Collection8,9
Retrospective collection involves the use of biospecimens that have already been stored or archived. These include clinical remnants - samples left over from routine clinical testing - and banked specimens, which have been collected by academic, commercial or hospital biorepositories for future use in research and development. Although still IRB approved, samples in this case do not come with donor visibility as they have been fully de-identified.
Understanding base matrices
A base matrix is the foundational component of quality-control (QC) materials that are used in in vitro diagnostic (IVD) testing. The base matrix can be a biological fluid (such as serum, plasma, saliva or urine) or a synthetic medium like a gel – anything that mimics a clinically relevant human specimen tested in a hospital or laboratory.8
A base matrix is crucial for the effective performance of QC material as it provides a stable environment in which the biological components can interact. This allows healthcare professionals to be confident in the results they obtain during patient testing.8
Using a high-quality base matrix ensures accurate, consistent test results and helps to prevent unwanted reactions that could interfere with the outcomes.8
The use of base matrices in quality controls
The application of base matrices in the QC landscape is vast. From replicating the physiological conditions of testing to providing sample stability, base matrices help to ensure consistency and accuracy between assays while minimizing interference.9
The use of base matrices in calibrators
Like base matrices, calibrators – specially prepared samples used to set the standards for a test – are also made using a base matrix containing known concentrations of the target substance.9
By running a calibrator through the testing system, testers can create a reference point that helps them to interpret patient results and ensure assays and testing platforms are performing appropriately. It’s essential that calibrators be accurate, consistent and of the highest quality – all of which is driven by the base matrix used.9
| “Processed plasma and serum serve as indispensable starting materials in the field of in vitro diagnostics, playing a pivotal role in the manufacturing of quality controls and calibrators that are essential across several platforms, including immunoassays, chemistry assays and molecular diagnostics. These materials provide a reliable foundation for ensuring the accuracy and consistency of diagnostic results, underpinning their crucial role in healthcare, research and disease management. Their versatility and quality are essential in maintaining the high standards demanded by the diagnostic industry.” - Medix Biochemica, 202310 |
How base matrices provide accurate, consistent performance from lot to lot8
- Characterization: Base matrices are defined by key properties including pH, conductivity, bioburden and other critical factors to ensure consistent quality across batches and to meet customer expectations. This characterization also ensures that the matrices closely replicate the 'real-world' samples that the testing clinics will process on the same equipment.
- Stable environment: The base matrix creates optimal conditions for test reactions, leading to more consistent results. By maintaining controlled conditions, matrices also prevent degradation and performance changes over a reasonable period.
- Minimal interference: A high-quality base matrix minimizes the chances of unexpected reactions or high background (e.g. excessive color development) that could affect test results.
Click on the links below to read more about base matrices:
Multianalyte Controls Part 1: Base Matrix Considerations
Saliva Testing: The Shift to Saliva in Sample Testing
Bulk biologicals and their benefits
Bulk biologicals are biological materials that are available in larger quantities than would typically be found through remnant samples alone. Bulk biologicals can also be processed and customized to meet the needs of the end user.8,9
The key benefits of using bulk biologicals for IVD manufacturers include:8,9
- Streamlined supply chain: Access to a reliable supply of biologicals can make it easier for manufacturers to plan and manage their inventory.
- Minimal lot-to-lot variation: Purchasing biologicals in larger batches provides greater consistency due to the larger sample size.
- Cost-effectiveness: Buying biologicals in bulk quantities is typically more affordable than buying smaller batches, reducing the overall costs of manufacturing a test.
- Uniform quality: When using bulk biologicals, the biological materials are often produced under controlled conditions, leading to more consistent quality across different batches. This helps ensure that tests provide reliable results every time.
- Scalability: Bulk biologicals allow manufacturers to rapidly produce large volumes of tests. This is especially important in cases of high demand or in an emergency like a pandemic.
- Less waste: Buying in bulk involves less packaging waste and fewer single-use items, making it a more environmentally friendly choice.
Medix Biochemica Biospecimens, Base Matrices, & Bulk Biologicals Customization Matrix
Contact us discuss your requirements:
