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.
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
Select the biological matrix and level of processing based on specimen type, analyte requirements, and intended QC application.
Patient-like matrix
A higher-protein human serum matrix designed to more closely resemble fresh patient serum for quality control during manufacturing and diagnostic applications.
Processed matrix
Human serum processed to achieve an appropriate starting background for control formulation and manufacturing.
Custom formulation
Biological matrices formulated to defined analyte concentrations, including levels selected around clinically or analytically important points in the assay range.
Urine matrix
Processed human urine for drugs-of-abuse, toxicology, metabolite, and other urine-based control applications.
Protein-based matrix
HSA provides a controlled protein background where a full native serum matrix is not required.
Specialty matrix
Specialty serum matrices where endogenous analyte concentration must be minimized before formulation or spiking.
Custom QC manufacturing
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
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.
Serum, urine, HSA, or specialty material selected around the intended specimen and assay.
Adjust analyte background, clarity, lipid content, protein characteristics, or other requirements.
Establish the desired formulation and defined analyte concentration or control levels.
Produce qualified materials for routine supply, bulk QC, OEM, or finished-control applications.
Assay verification
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
During assay development, controls at low, normal, elevated, and other critical concentrations can help evaluate precision, recovery, sensitivity, and overall method performance.
Manufacturing
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
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
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
Explore finished controls, biological matrices, and lot-specific documentation.
Ready-to-use control materials for routine assay performance monitoring.
View controlsHuman serum, plasma, urine, HSA, and specialty biological matrices.
Explore biomaterialsSearch available product lots of Monobind QSure® controls and Bio-Rad QC materials with value ranges for Monobind assays.
Search control valuesCustom quality control solutions
Tell us what you are developing and the matrix, analyte, or formulation you need.