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Rows of glass vials in controlled cold storage
Quality & performance

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.

Commutability

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.

Stability

Analyte stability, measured in real time and under stress

Real-time stability

Study design
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
One week of incubation at 37 °C
Reference condition
Samples stored at +2 to 8 °C
Replicates
Triplicate measurements for each condition
Acceptance
A change of less than 20% between conditions is expected

Stability data for a specific lot is provided with the lot documentation on request.

Homogeneity & consistency

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.

Handling

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.

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