Five Solutions to Ensure Proper Base Matrix Performance

What is a base matrix?

A base matrix is the primary component of the quality-control (QC) materials used in in vitro diagnostic (IVD) testing. The base matrix can be anything that mimics a clinically relevant human specimen tested in a hospital or laboratory – for example, a biological fluid (saliva, serum, plasma or urine) or a synthetic gel medium. Base matrices are essential for the effective performance of QC material, as they provide a stable environment in which the biological components can interact. This means healthcare professionals can be confident in the results they get during patient IVD testing.^1,2

What happens when a base matrix doesn’t measure up to the required standards, and what steps can be taken to prevent this?

Using a high-quality base matrix ensures accurate, consistent test results and helps to prevent unwanted or unexpected reactions that could interfere with the outcomes. This is essential for successful biospecimen research and testing.^1,2

Read more: Multianalyte Controls Part 1: Base Matrix Considerations

The effects of a poor base matrix

Using a poor-quality base matrix may interfere with the chemical reactions needed for accurate testing, or significantly reduce the sensitivity of a test. Working with a poorly developed base matrix could produce inaccurate results, seriously impacting the confidence in any subsequent tests performed by the testing facility.^1-3

Understanding the specific challenges in diagnostic testing, specifically the base matrix, is crucial for tailoring effective solutions. When developing a base matrix, there are several types of issues that can arise, each with unique needs.¹ 

• Signal interference and background noise
• Poor reproducibility
• A negative impact on sample stability and quality
• Compromised quality control
• Lower assay sensitivity and specificity (leading to false-positive or false-negative results)

Read more: False Positives: What are the Risks?

Here are five solutions to address the challenges of working with base matrices and to ensure optimal results.

Solutions to address potential problems with base matrices

1. Well-defined performance needs¹
Defining product performance requirements is essential to prevent underperforming or failed batches. Factors like stability, pH level and bioburden must be carefully considered to create a product that performs consistently for its intended use. Defining and controlling these factors can be key to the success of a base matrix.

2. Correct handling¹ 
Following the proper storage and handling requirements of a base matrix, such as the shelf life and optimal storage temperature, are crucial. From the initial design stages, manufacturers should consider the necessary storage, collection, shipping and packaging processes involved to ensure that the product stays within its limits. For example, adding a protease inhibitor or preservative during the design process can improve the product’s shelf life while correct handling is essential to ensuring product integrity.

3. Sourcing and regulatory requirements¹
The source requirements for a base matrix depend on its intended end use and are largely dictated by the end user themselves. Manufacturers must consider the relevant regulatory requirements, collection site qualifications, donor traceability and screening to ensure a safe process from the collection site right into the hands of the end user (i.e. laboratory or hospital staff).

4. Scaling and batch-to-batch consistency¹
Conducting a small-scale feasibility trial is necessary to ensure all base matrix requirements can be consistently met. This allows for adjustments to the manufacturing process, or product specifications before producing a full-scale test batch. This ensures not only does the process work, but it also works consistently and at the desired scale.

5. Customization and collaboration¹
Clients often have specific requirements, and customization is key to meeting these needs. By offering tailored solutions, such as delipidation, charcoal stripping, defibrination and other processing methods, we can address unique challenges with base matrices and achieve the performance needed. 

By understanding and addressing the five key challenges discussed here, we can improve the quality and reliability of IVD test performance, ensuring reliable outcomes for our customers and their patients.¹

Medix Biochemica follows a stringent ISO certified manufacturing process, with low bioburden, and we’re able to produce large batches at consistent quality.3 For example, we have large-scale manufacturing capabilities for base matrices (> 1 000 liters per batch).3 Our base matrices portfolio includes normalized human serum, defibrinated plasma and charcoal-stripped plasma, as well as numerous capabilities available for customization to meet a customer’s specific needs.6

Partnering with Medix Biochemica gives you access to exceptional quality, highly customizable base matrices, technical expertise and a wealth of other IVD critical raw materials.

Contact us to discuss your requirements:

References:

1. Expert opinion. Anthony Austin, Global Marketing Manager, Medix Biochemica. October 2024.
2. Expert opinion. Ryan Fitzgerald, Product Manager - Biospecimens, Base Matrices, Biologicals, Medix Biochemica. October 2024.
3. Expert opinion. Ryan Fitzgerald (Product Manager - Biospecimens, Base Matrices, Biologicals, Medix Biochemica), Brooke Knaust (Medix Weston Site Lead: Director, Product Manager - Biospecimens, Base Matrices, Biologicals, Medix Biochemica), and Nicole Njuguna (Product Manager - Proteins, Antigens, Enzymes, Medix Biochemica). May 2023.
4. Dilapidated. Collins English Dictionary. Accessed November 6, 2024. https://www.collinsdictionary.com/dictionary/english/delipidated.
5. Defibrinate. Collins English Dictionary. Accessed November 6, 2024. https://www.collinsdictionary.com/dictionary/english/defibrinate.
6. Base matrices. Medix Biochemica. Accessed November 6, 2024. https://www.medixbiochemica.com/our-products/product-categories/base-matrices/