Quality control
Independent controls, calibrators and linearity materials for internal quality control in clinical chemistry: Randox Acusera and AUDIT MicroControls.
Products
Acusera controls are not manufactured or optimised for any particular reagent, method or analyser, so they can be used on different instruments. The Randox range covers more than 390 analytes. We supply a multi-analyte control for 67 analytes, a lipid control, cystatin C, aldolase and Lp(a) controls, and calibrators.
In Finland we supply Randox Acusera controls and calibrators, AUDIT MicroControls linearity materials and controls, and Instruchemie CRP controls for the QuikRead go and Afinion AS100 analysers. AUDIT linearity sets usually have five levels equally spaced across the measuring range and are used to verify calibration.
Acusera Human Assayed Multi-Sera
Comprehensive chemistry control: 67 analytes in a single vial, levels 2 and 3.
General chemistry linearity sets
Five-level sets for calibration and reportable range verification: a general set for 29 analytes, plus general chemistry and bilirubin sets for Roche analysers.
CRP Controls
Liquid CRP controls at three levels for QuikRead go and Afinion AS100 instruments, and routine controls for automated analysers.
Applications
Daily multi-analyte control
67 analytes
A single vial covers routine chemistry, enzymes, electrolytes, lipids, immunoglobulins, thyroid tests and therapeutic drugs.
Lipids
7 analytes, 3 levels
The lipid control contains no preservatives, so it does not interfere with direct HDL and LDL cholesterol methods. The Lp(a) control is designed for the Randox Lp(a) assay.
Speciality assays
Cystatin C and aldolase
The cystatin C control is liquid and stable for 30 days after opening. The aldolase control is available at levels 2 and 3.
Calibration
39 analytes
The calibration serum contains 39 analytes, and the Lp(a) calibrator set has five points with values in nmol/l.
Calibration verification
5 equally spaced levels
The general linearity set covers 29 chemistry analytes. For Roche analysers there is a dedicated general chemistry set and a bilirubin set.
Chemistry and urine
32 and 14 analytes
The clinical chemistry control is human serum based and stable for 14 days once reconstituted. The urine chemistry control also includes microalbumin and osmolality.
Immunoassay and therapeutic drugs
17 analytes, 12 drugs
The immunoassay control covers thyroid tests, reproductive hormones, ferritin, folate and vitamin B12. The vitamin D control is a frozen liquid.
Immunoassay controlLyophilised three-level control for 17 analytes: thyroid tests, reproductive hormones, ferritin, folate, vitamin B12, cortisol and digoxin.
TDM controlLyophilised three-level control for measuring the concentrations of 12 drugs. Stable for 30 days once reconstituted.
Vitamin D controlFrozen liquid two-level control for vitamin D assays. Stable for 30 days at +2…+8 °C once thawed.
Cardiac and inflammatory markers
Troponin I, BNP, PCT and CRP
The cardiac marker control contains high-sensitivity troponin I, CK-MB and myoglobin. The liquid CRP controls are stable for 30 days after opening.
Cardiac marker controlsLyophilised controls for troponin I, CK-MB and myoglobin (3 levels) and for BNP and NT-proBNP (2 levels).
Procalcitonin controlLyophilised two-level control for procalcitonin assays. Stable for 7 days once reconstituted.
CRP controlsReady-to-use liquid controls for CRP and rheumatoid factor (3 levels) and high-sensitivity CRP (2 levels). Stable for 30 days after opening.
CRP point-of-care tests
QuikRead go and Afinion AS100
The Instruchemie liquid point-of-care controls have three levels, at about 20, 66 and 94 mg/l. There are two pack sizes, 12 × 1 ml and 10 × 200 µl.
HbA1c
2 levels, human blood
The liquid control is stable for 50 days after opening. The lyophilised control is reconstituted with 0.5 ml of water.
Controls side by side
| Multi-Sera | Lipid | Cystatin C | Lp(a) | |
|---|---|---|---|---|
| Analytes | 67 | 7 | 1 | 1 |
| Format | Lyophilised | Lyophilised | Liquid | Lyophilised |
| Matrix | Human serum based | 100% human serum | Human serum based | 100% human serum |
| Levels | 2 and 3 | 1, 2 and 3 | 2 and 3 | 1 |
| Reconstituted or opened | 7 days +2…+8 °C, 28 days −20 °C | 7 days +2…+8 °C, 28 days −20 °C | 30 days +2…+8 °C | 14 days +2…+8 °C |
Multi-Sera
- Analytes
- 67
- Format
- Lyophilised
- Matrix
- Human serum based
- Levels
- 2 and 3
- Reconstituted or opened
- 7 days +2…+8 °C, 28 days −20 °C
Lipid
- Analytes
- 7
- Format
- Lyophilised
- Matrix
- 100% human serum
- Levels
- 1, 2 and 3
- Reconstituted or opened
- 7 days +2…+8 °C, 28 days −20 °C
Cystatin C
- Analytes
- 1
- Format
- Liquid
- Matrix
- Human serum based
- Levels
- 2 and 3
- Reconstituted or opened
- 30 days +2…+8 °C
Lp(a)
- Analytes
- 1
- Format
- Lyophilised
- Matrix
- 100% human serum
- Levels
- 1
- Reconstituted or opened
- 14 days +2…+8 °C
Westgard rules
Control limits on a Levey-Jennings chart are set at the mean ±2 or ±3 standard deviations. Multirule quality control combines several rules to reduce the false alarms of 2s limits and to detect errors better than 3s limits alone. Using the 1-2s rule alone falsely rejects about 9% of runs with two controls.
Up to ten custom multirules can be defined on the RX imola analyser, and the RX analysers plot Levey-Jennings charts themselves.
- 1-2s: warning, check the control results
- 1-3s: reject the run when one control exceeds ±3s
- 2-2s, R-4s, 4-1s and 10x: rejection rules for systematic and random error
Internal and external quality assessment
Internal quality control. According to Randox, ISO 15189:2022 recommends considering independent controls alongside or instead of the manufacturer's controls.
External quality assessment. In Finland, EQA rounds are organised by Labquality. The rounds complement internal quality control but do not replace it.
Glossary
Independent control
A control that is not manufactured or optimised for a particular reagent, method or analyser.
Commutability
The ability of a control to behave like a patient sample in the assay.
Assayed control
A control for which the manufacturer has assigned target values and ranges by instrument, method and temperature.
Westgard rules
A multirule approach to deciding from control results whether to accept a run.
Manufacturers
Randox: quality control and clinical chemistryAcusera controls from Randox monitor assay accuracy independently of the analyser. Randox also manufactures the RX series clinical chemistry analysers and speciality reagents.
AUDIT MicroControls: calibration verification and controlsAUDIT MicroControls linearity materials verify calibration across the whole measuring range. For daily quality control, the range includes controls for clinical chemistry, immunoassays, HbA1c and cardiac markers, among others.
Instruchemie: speciality reagentsReagent kits from the Dutch manufacturer Instruchemie for less common assays such as ACE, G6PDH, pyruvate kinase, oxalate and citrate, and CRP controls for QuikRead go and Afinion AS100 instruments.
We deliver from our own warehouse.
We advise on choosing and using the product.
Frequently asked questions
If you cannot find an answer, call +358 10 841 1600 or email asiakaspalvelu@diagnostica.fi.
Why use an independent control?
According to Randox, an independent control assesses assay performance without bias and can reveal errors that the manufacturer's own controls do not show.
Are Acusera controls suitable for all analysers?
According to Randox, the controls are suitable for any instrument and method. Target values for the multi-analyte control are assigned by instrument, method and temperature for a wide range of analysers.
How long is a reconstituted control stable?
Once reconstituted, Acusera controls are stable for 5–28 days at +2…+8 °C, depending on the product. The multi-analyte control and the lipid control can also be frozen. The liquid cystatin C control is stable for 30 days after opening. AUDIT controls are stable for 2–50 days: BNP for the shortest time, the liquid HbA1c control for the longest.
How much do the controls cost?
We provide prices in our quote. Tell us the analytes, levels and quantities you need and we will put together a quote.