Bulk POCT controls in human matrix, ready to use.
Three control lines, glucose, CRP and hs-CRP, each in three levels and supplied in bulk to the device they have to verify.
Three control lines, available now
Each line is produced in Germany, supplied in bulk, and released against defined error limits. Bottle labels shown are illustrative.
POCT Glucose Control
Glucose meters and analysers, covering low, normal and elevated levels.
- Analyte
- Glucose
- Matrix
- Liquid, human blood
- Levels
- Level 1, Level 2, Level 3, covering low, normal and elevated decision levels
- Reference codes
- HS201-015-1, HS201-015-2, HS201-015-3
- Filling volume
- 1 mL
- Shelf life
- 3 months, with a recommended 12 weeks of use from manufacturing
- Presentation
- Liquid, ready to use, no reconstitution step
- Storage
- +2 to 8 °C
- Lot release
- Homogeneity to ISO 13528; Rilibäk total allowable error limits for glucose
- Supply
- Bulk, for IVD manufacturers and supply chains
POCT CRP Control
CRP meters and analysers, covering low, normal and elevated levels.
- Analyte
- C-reactive protein (CRP)
- Matrix
- Liquid, human blood
- Levels
- Level 1, Level 2, Level 3
- Reference codes
- HS201-016-1, HS201-016-2, HS201-016-3
- Filling volume
- 1 mL
- Shelf life
- 3 months, with a recommended 12 weeks of use from manufacturing
- Presentation
- Liquid, ready to use, no reconstitution step
- Storage
- +2 to 8 °C
- Lot release
- Homogeneity to ISO 13528; Rilibäk total allowable error limits for CRP
- Supply
- Bulk, for IVD manufacturers and supply chains
POCT hs-CRP Control
High-sensitivity CRP control material in a liquid human serum matrix, for the low concentration range used in cardiovascular risk assessment, with a 12-month shelf life.
- Analyte
- High-sensitivity C-reactive protein (hs-CRP)
- Matrix
- Liquid, human serum
- Levels
- Level 1, Level 2, Level 3
- Reference codes
- HS201-017-1, HS201-017-2, HS201-017-3
- Filling volume
- 1 mL
- Shelf life
- 12 months
- Presentation
- Liquid, ready to use, no reconstitution step
- Storage
- +2 to 8 °C
- Lot release
- Homogeneity to ISO 13528; Rilibäk total allowable error limits for CRP
- Supply
- Bulk, for IVD manufacturers and supply chains
Products, levels and reference codes
Every level has its own reference code. Quantities, documentation and cold-chain shipping are confirmed per order.
| Product | Matrix | Filling volume | Reference code | Shelf life |
|---|---|---|---|---|
POCT Glucose ControlLevel 1, Level 2, Level 3 | Liquid, human blood | 1 mL | HS201-015-1HS201-015-2HS201-015-3 | 3 months |
POCT CRP ControlLevel 1, Level 2, Level 3 | Liquid, human blood | 1 mL | HS201-016-1HS201-016-2HS201-016-3 | 3 months |
POCT hs-CRP ControlLevel 1, Level 2, Level 3 | Liquid, human serum | 1 mL | HS201-017-1HS201-017-2HS201-017-3 | 12 months |
Beyond the catalogue: controls developed for your analyte
The three lines above are what we hold as standard. Most projects start from a device and an analyte that is not on this list.
- Analyte range
- Clinical chemistry and immunoassay analytes measured on point-of-care platforms, single analyte or combined in one vial. Feasibility is confirmed per analyte before development starts.
- Platforms
- Handheld meters, desktop POCT analysers and cassette readers. Recovery is verified on your platform during validation.
- Matrix and format
- Human blood or human serum, liquid and ready to use, in vial or bulk formats to your fill volume.
- Levels and targets
- Level count and target values positioned where they are clinically useful for your assay range.
- Supply model
- Bulk material for your own filling, labelling and release, including OEM and private-label supply.
How supply is organised
Controls are produced to an agreed specification and shipped as bulk material for your own filling, labelling and release.
Specify
We agree analytes, levels, target values and fill volume with you, and remove parameters you do not need.
Manufacture and release
Each lot is tested for stability and vial-to-vial homogeneity and released against defined error limits.
Repeat lots
Target values are held consistent across lots, so your customers see familiar results over time.
Lot documentation, including stability and homogeneity data, is supplied on request. Ask for a quotation.