Tested lot by lot, released against defined limits.
Every performance claim on this site corresponds to a test carried out on the production lot before it leaves us, and the documentation behind it is available on request.
Human matrix, so the check is real
Our POCT controls are based on human serum and blood. That matters because a control only verifies a device if it behaves on that device the way a patient sample does. Artificial or heavily modified matrices can interact differently with the reagent system, producing matrix effects that either hide a genuine problem or imitate one that does not exist.
Working with a human matrix keeps matrix effects minimal and makes the control result directly comparable to patient results on the same analyser.
Study design. Each level of a released production lot was measured on every platform listed and compared with the assigned target value. Recovery is reported as a percentage of that target value. All results fall between 99 and 102%.
Analyte stability, measured in real time and under stress
Real-time stability
- Study design
- Level 2 material from a released lot, measured at defined time points after manufacturing, expressed in weeks
- Replicates
- Each sample measured three times at every time point
- Recommended shelf life
- 12 weeks for blood-based POCT CRP and POCT Glucose Controls
Accelerated stability
- Stress condition
- Incubation at 37 °C for 3 and 7 days
- Reference condition
- Samples stored at +2 to 8 °C
- Replicates
- Triplicate measurements for each condition
- Acceptance criterion
- A change of less than 20% between conditions
Values shown are from representative production lots. Stability data for a specific lot is provided with the lot documentation on request.
The same material in every vial, and in the next lot
Vial-to-vial homogeneity
Random vials are selected after filling and tested in accordance with ISO 13528. After statistical evaluation, batches are released using the total allowable error limits for CRP and glucose defined in the Rilibäk guideline.
Minimal lot-to-lot variation
Consistent target values are maintained across production lots, which gives familiar results and keeps long-term quality records comparable.
Clinically relevant levels
Levels are chosen to assess assay performance in relation to the assay range and to the critical values that matter for clinical decision making.
Supporting documents for your evaluation
Each document is prepared for the product and lot you are assessing. Ask for the ones you need and we send them with the quotation.
Technical report
Formulation principle, matrix, level design and intended use of the control material.
Request this document →Validation summary
Commutability, stability and homogeneity studies with study design, acceptance criteria and results.
Request this document →Sample certificate of analysis
An example COA showing assigned target values, acceptance ranges and release statement per level.
Request this document →Stability data
Real-time and accelerated stability results for the lot you are evaluating.
Request this document →Platform compatibility table
Recovery per level on the CRP and glucose platforms tested, and platforms added since.
Request this document →Ready to use, by design
Verilox controls are supplied as ready-to-use liquid material. There is no reconstitution step, no weighing and no dilution at the point of care, which removes a common source of operator error and makes the control faster to run in a busy clinical setting.
Adjust volumes, levels and target values →