In a world of continual change and fast-paced innovation, one constant remains – the need for precise, accurate hospital laboratory test results.1 Multianalyte controls are an essential part of quality control, especially when it comes to large test-volume requirements.1 Medix Biochemica provides the IVD market with quality raw materials for the production of multianalyte controls, bringing technical expertise and in-depth understanding to each collaboration.2
What are Multianalyte Controls?
In medical testing, a control with a known value must be used to establish the accuracy and precision of analytical equipment.2a,2b This gives laboratories, and medical professionals confidence that the results they get from their analyses are sound.2a,2b
Within a typical testing laboratory, controls are run at least once per day to check the accuracy of the testing equipment, helping to ensure reliable and reproducible test results.2a,2b
As the name implies, a multianalyte control is designed to test or measure a variety of different analytes.2a,2b This type of control is made from a combination of raw materials, such as proteins and hormones, and has known values for various biomarkers.2a,2b
Multianalyte vs single-analyte controls
Multianalyte and single-analyte controls have the same function and quality – the only difference between them lies in the number of analytes 2a,2bA single-analyte control is limited to contain one analyte only.2a,2b
Multianalyte controls offer a much wider analyte base, which makes them preferable and more time-efficient when testers have a wide range of analyses to perform.2a,2b A comprehensive multianalyte control could be capable of covering most, if not all, of a laboratory’s control testing.2a,2b
As an added benefit, in comparison to single-analyte controls, multianalyte controls reduce the amount of waste produced through traditional laboratory processing.2a,2b This is because just one bottle of control can be used to test a whole panel of analytes.2a,2b
What is the Base Matrix in a Multianalyte Control?
Every multianalyte control starts with a base matrix – the primary material used to make up that control.1 The base matrix can be anything that mimics a clinically relevant human specimen that would be tested in a hospital or laboratory, e.g. plasma, serum, or urine.1
What makes a base matrix trustworthy?
All base matrices must be carefully designed to ensure accurate test results to empower healthcare providers to make sound medical decisions.1 There are several factors that a trustworthy manufacturer will consider when designing a base matrix for a successful multianalyte control:1
Design factor 1: Performance
Defining the product performance requirements puts parameters in place to prevent underperforming or failed batches. Factors like stability, pH, and bioburden must all be carefully considered, to create a product that works for its intended use and performs consistently.
Design factor 2: Handling
It’s essential to know the storage and handling requirements of a base matrix, such as its shelf life and optimal temperature. Storage should be considered in the first stages of designing the base matrix, and collection, shipping, and packaging processes must also be examined to ensure that the product stays within its storage limits. Sometimes, a protease inhibitor or preservative may be added to improve shelf life.
Design factor 3: Sourcing
The source requirements for a base matrix will typically depend on its intended end use. When sourcing materials, manufacturers must consider the requirements of the relevant regulatory bodies, the qualifications of the collection site, donor traceability, and screening. All this ensures a safe process, from the collection site into the hands of hospital staff.
Design factor 4: Feasibility and scaling
Once the manufacturer has determined all the base matrix requirements, they must also conduct a small-scale feasibility trial, to ensure that all requirements can be met consistently. Any adjustments to the manufacturing process or product specifications can then be made, before producing a full-scale test batch.
How to create a successful base matrix
3 main factors play a role in ensuring that a base matrix mimics clinically relevant patient samples:2a,2b
Success factor 1: Sampling size to ensure consistency
The base matrix must start with an appropriate patient population sample size that is large enough to ensure a consistent product. Each individual sample will vary slightly (for example, each patient's cholesterol will vary from person to person and may change over time). To minimize the effects of individual variabilities, using many starting samples means these variabilities are ‘normalized’ and ensures a consistent average base matrix starting point.1
Success factor 2: Characterization
The base matrix must be characterized in terms of pH, conductivity, bioburden, etc. This establishes its critical properties for batch-to-batch consistency and ensures customer satisfaction. This characterization also ensures a close mimic to the ‘real world' samples the testing clinic will run on that same machine.1
Success factor 3: In-depth processing
The necessary processing procedures – such as filtration, defibrination, and delipidization – must be performed to ensure that the final product meets the end user’s needs.
Of course, many other factors come into play beyond those discussed here, and Medix Biochemica collaborates with customers to ensure that the base matrix they receive is in line with their needs.2a,2b
The impact of a poor-quality base matrix
A poor-quality matrix (e.g. one that is contaminated with interfering substances, diluted or not designed to the correct specifications) could interfere with the chemical reactions needed for accurate testing or drastically reduce the sensitivity needed in detecting low levels of target analytes. A multianalyte control made with a poorly developed base matrix could therefore severely impact the confidence in the results of any subsequent test performed by that machine or testing facility. 1
Here are two common mistakes manufacturers make when producing base matrices, both of which can impact the quality of a control:2a,2b
Common mistake #1. Small batch size
Smaller batches run out quickly, and running more batches increases the risk that the matrix quality or batch-to-batch consistency will be affected.
|Medix Biochemica can produce over 1 000 liters of high-quality, consistent base matrix per batch, in a cleanroom environment. This allows for an adequate sample size of starting material to ensure that the end user can expect consistent material and quality every time.|
Common mistake #2. Lack of customization
Another common mistake is trusting a ‘one-size-fits-all’ solution instead of relying on a product that’s tailored to specific testing needs. Customization is key to customer success and requires significant planning as well as an in-depth understanding of the analytes involved.
|Through close collaboration with our customers, Medix Biochemica can provide customized base matrices, analytes, and processed plasma products – all tailored to the end user’s needs.|
Next Steps: From Base Matrix to Multianalyte Control
Once a high-quality base matrix has been designed and developed, raw material components are introduced to create the finished multianalyte control.1 These materials are determined according to the control’s intended end use(s).1
Manufacturers must consider:1
- The ability of the control to mimic clinically relevant patient samples
- The cost of each raw material
- The potential interactions between the various materials
- The potential for contamination or dilution
- The need for the addition of a highly purified material
Medix Biochemica's Materials Empower Customers to Create Quality Multianalyte Controls
Medix Biochemica is a market-leading in vitro diagnostics (IVD) material supplier that provides all the components needed to produce successful multianalyte controls – including analytes, processed plasma, serum, and base matrices.1,2a,2b This allows our IVD customers around the globe to manufacture quality controls.1
What sets us apart from other suppliers in the market today?
Our relationships with our customers aren’t just transactional.2a Medix Biochemica takes a collaborative approach and partners with customers to ensure they have materials that are properly tailored to their needs.2a,2b This collaboration goes hand-in-hand with the in-depth scientific knowledge we bring to the table.2a,2b
Exceptional research and development
Our knowledgeable R&D teams add value to each customer experience by assisting with customized development, technical troubleshooting, and more.2a We believe that enhancing every potential customer’s understanding helps to move the market forward.2
Understanding of complex materials
Customers can be assured that they’re sourcing material from a supplier that has long-established experience with – and understanding of – the materials, including potential reactions and interferences affecting those materials.2a The Medix Biochemica team also understands the potential complications and pain points our clients face.2a
Predicting and meeting customer demand
We have tools in place to forecast any customer demand for analytes and other materials, so we can plan out the number of builds required and source the starting materials accordingly.2a We also have strong relationships with raw material suppliers, which helps us to keep on top of the supply of critical materials like plasma and serum.2a
Medix Biochemica follows a stringent ISO certified manufacturing process, with low bioburden,2a,2b and we’re able to produce large batches of consistent quality:
- Large-scale manufacturing capabilities for processed plasma (1 200 liters per batch)2b
- Large-scale manufacturing capabilities for base matrices (> 1 000 liters per batch)2a
- Large-scale manufacturing capabilities for analytes (in kg quantities)2a
As a company, Medix Biochemica cares about expanding capabilities to provide customers with what they need, making sure we offer long-term supplier security.2a,2b After more than 30 years in the industry,3 we look forward to a future of greater innovation and even better industry-leading services.
|Improved collaboration + Improved understanding = Greater innovation2a|
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1. Expert opinion. Multianalyte controls – enabling concise, accurate results to billions of patients. Anthony Austin, Global Marketing Manager, Medix Biochemica. May 2023.
2a. Expert opinion. Interview with 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 17, 2023.
2b. 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.
3. About us. Medix Biochemica. Accessed May 30, 2023. https://about.medixbiochemica.com.