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  • Quality Control Matrices & Control Materials | Monobind

Focus Area

Quality Control

Patient-like matrices and custom QC materials.

Matrices Designed Around the Control

Monobind provides human-derived and specialty matrices for quality-control development and manufacturing — from patient-like serum and processed urine to custom-spiked materials formulated to defined analyte levels.

QC matrices & control materials

Quality Control Product Focus Areas

Select the biological matrix and level of processing based on specimen type, analyte requirements, and intended QC application.

Patient-like matrix

Off-the-Clot Human Serum

A higher-protein human serum matrix designed to more closely resemble fresh patient serum for quality control during manufacturing and diagnostic applications.

  • Higher protein content
  • Closer to fresh patient serum
  • Suitable as a QC base matrix
Explore off-the-clot serum

Processed matrix

Processed Human Serum

Human serum processed to achieve an appropriate starting background for control formulation and manufacturing.

  • Stripped matrices
  • Delipidated serum
  • Defibrinated material
Explore processed serum

Custom formulation

Custom-Spiked QC Matrices

Biological matrices formulated to defined analyte concentrations, including levels selected around clinically or analytically important points in the assay range.

  • Low, normal & elevated levels
  • Clinical decision points
  • Single or multiple analytes
Tell us about your QC project

Urine matrix

Drug-Free & Optically Clear Human Urine

Processed human urine for drugs-of-abuse, toxicology, metabolite, and other urine-based control applications.

  • Drug-free pooled urine
  • Optically clear processing
  • pH-treated formulations
Explore human urine

Protein-based matrix

Human Serum Albumin

HSA provides a controlled protein background where a full native serum matrix is not required.

  • ASO controls
  • Immunology & serology
  • Custom protein matrices
Explore HSA

Specialty matrix

Low-Analyte & Specialty Matrices

Specialty serum matrices where endogenous analyte concentration must be minimized before formulation or spiking.

  • Low hormone & steroid
  • Low vitamin matrices
  • Application-specific profiles
Explore specialty matrices

Custom QC manufacturing

Need a Matrix Built to Your Specification?

Monobind can process and formulate serum, urine, albumin, and specialty matrices to defined requirements including analyte background, target concentration, protein level, pH, preservatives, processing method, and manufacturing volume.

From matrix to control

Support Across the QC Workflow

Start with an appropriate biological matrix, then process, formulate, and scale to the control requirement. Monobind can support liquid or lyophilized QC materials for development, production, and final product inclusion, including applications involving labile analytes.

  1. Select the Matrix

    Serum, urine, HSA, or specialty material selected around the intended specimen and assay.

  2. Process the Material

    Adjust analyte background, clarity, lipid content, protein characteristics, or other requirements.

  3. Formulate & Spike

    Establish the desired formulation and defined analyte concentration or control levels.

  4. Scale for Manufacturing

    Produce qualified materials for routine supply, bulk QC, OEM, or finished-control applications.

Assay verification

Measure Performance at the Levels That Matter

Quality controls help verify that an assay performs as intended across clinically and analytically important concentration levels. Measuring only a single point may not adequately represent assay performance across the reportable range.

Assay development

Verify Performance Across the Range

During assay development, controls at low, normal, elevated, and other critical concentrations can help evaluate precision, recovery, sensitivity, and overall method performance.

Manufacturing

Confirm Production Consistency

Defined QC materials can be used during production to help verify that assay lots continue to perform within established specifications at important analyte levels.

Routine use

Monitor Ongoing Assay Performance

In routine testing, controls provide an independent check that the analytical system continues to perform acceptably before patient results are interpreted or reported.

Control level selection

Place Controls Near Key Clinical & Analytical Decision Points

Appropriate control concentrations depend on the assay and its intended use. Where relevant, controls may be positioned near reference limits, clinical decision thresholds, low-end sensitivity requirements, or other concentrations where assay accuracy and precision are especially important.

Continue exploring

Quality Control Resources

Explore finished controls, biological matrices, and lot-specific documentation.

Custom quality control solutions

Tell Us About Your Quality Control Project

Tell us what you are developing and the matrix, analyte, or formulation you need.