Bilirubin Elevated Quality Control

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Bilirubin Elevated Quality Control

Therapeutic Drug Quality Control

The Randox Acusera Bilirubin Elevated control is designed to monitor the accuracy and precision of bilirubin assays used in paediatric testing. Assayed method specific target values are provided for both Total and Direct Bilirubin.

Features & Benefits

  • Lyophilised for enhanced stability
  • Bovine based serum
  • Assayed target values provided for Total and Direct Bilirubin
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 5 days at 2°C – 8°C
DescriptionSizeAnalytesCat No 
Bilirubin Elevated Control10 x 3ml2BE454

Analytes

  • Direct Bilirubin
  • Total Bilirubin

Aldolase Quality Control

Therapeutic Drug Quality Control

The Randox Acusera Aldolase control is specifically designed to monitor the accuracy and precision of Aldolase assays on a wide range of clinical chemistry instruments.

Features & Benefits

  • Lyophilised for enhanced stability
  • Human based serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of 5 days at 2°C – 8°C
DescriptionSizeAnalytesCat No 
Aldolase Control Level 23 x 1ml1AD5001
Aldolase Control Level 33 x 1ml1AD5002

Analytes

  • Aldolase

Bovine Chemistry Assayed Quality Control

Therapeutic Drug Quality Control

The Randox Acusera Bovine Chemistry Assayed control is designed for use in the routine monitoring of accuracy and precision. Assayed method and instrument specific target values are provided for 45 parameters including commonly used veterinary tests such as NEFA, Bile Acids, Lactate and D-3 Hydroxybutyrate.

Features & Benefits

  • Lyophilised for enhanced stability
  • Bovine based serum
  • Stable to expiry date at 2°C – 8°C
  • Reconstituted stability of up to 7 days at 2°C – 8°C or 4 weeks at -20°C
DescriptionSizeAnalytesCat No 
Bovine Chemistry Assayed Level 120 x 5ml45AL1027
Bovine Chemistry Assayed Level 220 x 5ml45AN1026
Bovine Chemistry Assayed Level 320 x 5ml45AE1032

Analytes

  • Alpha-HBDH
  • Acid Phosphatase (Non-Prostatic)
  • Acid Phosphatase (Prostatic)
  • Acid Phosphatase (Total)
  • Albumin
  • Alkaline Phosphatase
  • ALT
  • Amylase Total
  • AST
  • Bicarbonate
  • Bile Acids
  • Bilirubin Direct
  • Bilirubin Total
  • Calcium
  • Chloride
  • Cholesterol
  • CK Total
  • Copper
  • Cortisol
  • Creatinine
  • D-3-Hydroxybutyrate
  • Free T4
  • Gamma GT
  • GLDH
  • Glucose
  • Iron
  • Lactate
  • LDH
  • Lipase
  • Lithium
  • Magnesium
  • NEFA
  • Osmolality
  • Phosphate Inorganic
  • Potassium
  • Protein Total
  • PSA Total
  • Sodium
  • TIBC
  • Total T3
  • Total T4
  • Triglycerides
  • Urea
  • Uric Acid
  • Zinc

Liquid Chemistry Premium Plus Quality Control

Therapeutic Drug Quality Control

The Randox Acusera Liquid Chemistry Premium Plus control is designed for use in the routine monitoring of reproducibility and is the most comprehensive chemistry control available. As a true third party control it is suitable for use with all major instruments and covers over 100 parameters including routine chemistries, immunoassays, lipids, cardiac markers, proteins, therapeutic drugs and electrophoresis effective consolidation and significant cost savings are guaranteed.

Features & Benefits

  • Liquid for ease-of-use
  • Human based serum
  • High CRP levels also eliminate the need for separate controls
  • Stable to expiry date when at -20°C – 70°C
  • Open vial stability of up to 7 days at 2°C – 8°C
DescriptionSizeAnalytesCat No 
Liquid Chemistry Premium Plus Level 112 x 5ml101LUL5069
class="secondary-table-info">




Liquid Chemistry Premium Plus Level 212 x 5ml101LUN5070
Liquid Chemistry Premium Plus Level 312 x 5ml101LUE5071

Analytes

  • Alpha-1-Acid Glycoprotein
  • Alpha-1-Antitrypsin
  • Alpha-1-Globulin (electrophoreis)
  • Alpha-2-globulin (electrophoresis)
  • Alpha-HBDH
  • Acid Phosphatase (Total)
  • Albumin
  • Albumin (electrophoresis)
  • Alkaline Phosphatase
  • Amikacin
  • AFP
  • ALT
  • Amylase Pancreatic
  • Amylase Total
  • Apolipoprotein A-I
  • Apolipoprotein B
  • AST
  • B2 Microglobulin
  • Beta-globulin (electrophoresis)
  • Bicarbonate
  • Bile Acids
  • Bilirubin Direct
  • Bilirubin Total
  • C-Reactive Protein
  • Ceruloplasmin
  • Caffeine
  • Calcium
  • Carbamazepine
  • CEA
  • Chloride
  • Cholesterol
  • Cholinesterase
  • CK-Total
  • CK-MB
  • Complement C3
  • Complement C4
  • Copper
  • Cortisol
  • Creatinine
  • D-3-Hydroxybutyrate
  • DHEA-Sulphate
  • Digoxin
  • Ethanol
  • Ferritin
  • Folate
  • FSH
  • Free T3
  • Free T4
  • Gamma-globulin (electrophoresis)
  • Gamma-GT
  • Gentamicin
  • GLDH
  • Glucose
  • Haptoglobin
  • HDL Cholesterol
  • hCG
  • Growth Hormone
  • Immunoglobulin A
  • Immunoglobulin E
  • Immunoglobulin G
  • Immunoglobulin M
  • Iron
  • Lactate
  • LAP
  • LDH
  • LDL Cholesterol
  • Leutinising Hormone
  • Lipase
    • Lipoprotein (a)

    • Lithium
    • Magnesium
    • Myoglobin
    • Osmolality
    • Paracetamol
    • Phenobarbital
    • Phenytoin
    • Phosphate Inorganic
    • Potassium
    • Prealbumin
    • Progesterone
    • Prolactin
    • Protein Total
    • Salicylate
    • Sodium
    • Testosterone
    • Theophylline
    • TSH
    • Total T3
    • Total T4
    • TIBC
    • Transferrin
    • Triglycerides
    • Troponin T
    • T Uptake
    • UIBC
    • Urea
    • Uric Acid
    • Valproic Acid
    • Vancomycin
    • Vitamin B12
    • Zinc

    Precision Chemistry Premium Plus Quality Control

    Therapeutic Drug Quality Control

    The Randox Acusera Precision Chemistry Premium Plus control is designed to monitor the precision of routine chemistry tests. As a multi-analyte control it covers 86 parameters including a wide range of cardiac markers, drugs, immunoassays, lipids and proteins.

    Features & Benefits

    • Lyophilised for enhanced stability
    • Human based serum
    • Stable to expiry date at 2°C – 8°C
    • Reconstituted stability of up to 7 days at 2°C – 8°C or 4 weeks at -20°C
    DescriptionSizeAnalytesCat No 
    Precision Chemistry Premium Plus Level 220 x 5ml86UN1557
    Precision Chemistry Premium Plus Level 320 x 5ml86UE1558

    Analytes

    • Alpha-HBDH
    • Acid Phosphatase (Prostatic)
    • Acid Phosphatase (Total)
    • Albumin
    • Alkaline Phosphatase
    • Alpa-1-Acid Glycoprotein
    • Alpha-1-Antitrypsin
    • AFP
    • ALT
    • Amylase Pancreatic
    • Amylase Total
    • Apolipoprotein A-1
    • Apolipoprotein B
    • AST
    • Bicarbonate
    • Bile Acids
    • Bilirubin Direct
    • C-reactive Protein
    • Ceruloplasmin
    • Calcium
    • Carbamazepine
    • CEA
    • Chloride
    • Cholesterol
    • Cholinesterase
    • CK Total
    • Complement C3
    • Complement C4
    • Copper
    • Bilirubin Total
    • Cortisol
    • Creatinine
    • D-3-Hydroxybutyrate
    • Digoxin
    • Ferritin
    • Folate
    • Free T3
    • Free T4
    • Gentamicin
    • Gamma GT
    • GLDH
    • Glucose
    • Haptoglobin
    • hCG
    • HDL Cholesterol
    • IgA
    • IgE
    • IgG
    • IgM
    • Iron
    • Lactate
    • LAP
    • LDH
    • Lipase
    • Lithium
    • Magnesium
    • Myoglobin
    • NEFA
    • Phenytoin
    • Phosphate
    • Osmolality
    • Paracetamol
    • Phenobarbital
    • Potassium
    • Prealbumin
    • Prolactin
    • Protein Total
    • PSA Total
    • Salicylate
    • Sodium
    • Theophylline
    • TSH
    • T4
    • TIBC
    • Tobramycin
    • Transferrin
    • Triglycerides
    • T3
    • Troponin I
    • UIBC
    • Urea
    • Uric Acid
    • Valproic Acid
    • Vancomycin
    • Vitamin B12
    • Zinc

    Liquid Assayed Chemistry Premium Plus Quality Control

    Therapeutic Drug Quality Control

    With instrument specific target values provided for 99 analytes the Acusera Liquid Assayed Chemistry Premium Plus control is the most comprehensive on the market. Our unique combination of proteins, lipids, cardiac markers, therapeutic drugs, immunoassay and routine chemistry analytes enables effective consolidation and cost savings. As a true third party control target values are available for most major analysers.

    Features & Benefits

    • Liquid for ease of use
    • Human based serum
    • Assayed instrument specific target values and ranges
    • High levels of CRP and other proteins eliminate the need for multiple controls
    • Stable to expiry when stored at -20°C to -70°C
    • Open vial stability of up to 7 days at 2°C – 8°C
    DescriptionSizeAnalytesCat No 
    Liquid Assayed Chemistry Premium Plus Level 112 x 5ml99LAL4213
    Liquid Assayed Chemistry Premium Plus Level 212 x 5ml99LAN4214
    Liquid Assayed Chemistry Premium Plus Level 312 x 5ml99LAE4215

    Analytes

    • Albumin (Electrophoresis)
    • Alpha-1-Globulin (Electrophoresis)
    • Alpha-2-Globulin (Electrophoresis)
    • Beta-Globulin (Electrophoresis)
    • Gamma-Globulin (Electrophoresis)
    • Alpha-HBDH
    • α-1- Acid Glycoprotein
    • α-1-Antitrypsin
    • Β-2-Microglobulin
    • Acid Phosphatase (Total)
    • AFP
    • Albumin
    • Alkaline Phosphatase
    • Amikacin
    • ALT
    • Amylase
    • Amylase (Pancreatic)
    • Apo A-1
    • Apo B
    • AST
    • Bicarbonate
    • Bile Acids
    • Bilirubin Direct
    • Bilirubin Total
    • C-Reactive Protein
    • Caffeine
    • Calcium
    • Carbamazepine
    • CEA
    • Ceruloplasmin
    • Chloride
    • Cholesterol
    • Cholinesterase
    • CK Total
    • Complement C3
    • Complement C4
    • Copper
    • Cortisol
    • Creatinine
    • D-3-Hydroxybutyrate
    • DHEA Sulphate
    • Digoxin
    • Ethanol
    • Ferritin
    • Folate
    • FSH
    • Free T3
    • Free T4
    • Gamma GT
    • Gentamicin
    • GLDH
    • Glucose
    • Haptoglobin
    • hCG
    • HDL Cholesterol
    • IgA
    • IgE
    • IgG
    • IgM
    • Iron
    • Lactate
    • LAP
    • LDH
    • LDL Cholesterol
    • Leutinising Hormone
    • Lipase
    • LP(a)
    • Lithium
    • Magnesium
    • Myoglobin
    • Osmolality
    • Paracetamol
    • Phenobarbital
    • Phenytoin
    • Phosphate Inorganic
    • Potassium
    • Prealbumin
    • Progesterone
    • Prolactin
    • Protein Total
    • PSA Total
    • Salicylate
    • Sodium
    • Testosterone
    • Theophylline
    • Total T3
    • Total T4
    • TSH
    • TIBC
    • Transferrin
    • Triglycerides
    • Troponin T
    • T Uptake
    • Urea
    • Uric Acid
    • Valproic Acid
    • Vancomycin
    • Vitamin B12
    • Zinc

    Assayed Chemistry Premium Plus Quality Control

    Therapeutic Drug Quality Control

    The Randox Acusera Assayed Chemistry Premium Plus Control is designed to monitor both accuracy and precision of routine chemistry assays. As a true third party control assayed instrument and method specific target values are provided for 70 parameters including a wide range of lipids, cardiac markers, therapeutic drugs, immunoassays, proteins, routine chemistries and trace metals. Electrophoresis targets are also provided as a percentage breakdown of total protein.

    Features & Benefits

    • Lyophilised for enhanced stability
    • Human based serum
    • Assayed target values provided for 70 parameters
    • Typical Osmolality values: Level 2 is 300 mOsm/kg, Level 3 is 370 mOsm/kg
    • Stable to expiry date at 2°C – 8°C
    • Reconstituted stability of up to 7 days at 2°C – 8°C or 4 weeks at -20°C
    DescriptionSizeAnalytesCat No 
    Assayed Chemistry Premium Plus Level 220 x 5ml70HN1530
    Assayed Chemistry Premium Plus Level 320 x 5ml70HE1532
    Assayed Chemistry Premium Plus Level 2 and 32 x 5 x 5ml70HS2611

    Analytes

    • Alpha-1-Globulin (Electrophoresis)
    • Alpha-2-Globulin (Electrophoresis)
    • Alpha-HBDH
    • Acid Phosphatase (Non-Prostatic)
    • Acid Phosphatase (Prostatic)
    • Acid Phosphatase (Total)
    • Albumin
    • Albumin (Electrophoresis)
    • Alkaline Phosphatase
    • ALT
    • Amylase Pancreatic
    • Amylase Total
    • Apolipoprotein A-1
    • Apolipoprotein B
    • AST
    • Beta-1-Globulin (Electrophoresis)
    • Bicarbonate
    • Bile Acids
    • Bilirubin Direct
    • Bilirubin Total
    • Calcium
    • Chloride
    • Cholesterol
    • Cholinesterase
    • CK Total
    • Copper
    • Cortisol
    • Creatinine
    • D-3-Hydroxybutyrate
    • Digoxin
    • Folate
    • Free T4
    • Gamma-Globulin (Electrophoresis)
    • Gentamicin
    • Gamma-GT
    • GLDH
    • Glucose
    • HDL Cholesterol
    • Immunoglobulin A
    • Immunoglobulin G
    • Immunoglobulin M
    • Iron
    • Lactate
    • LAP
    • LDH
    • Lipase (Colorimetric)
    • Lipase (Turbidimetric)
    • Lithium
    • Magnesium
    • NEFA
    • Osmolality
    • Paracetamol
    • Phosphate Inorganic
    • Potassium
    • Protein Total
    • PSA Total
    • Salicylate
    • Sodium
    • Theophylline
    • Thyroid Stimulating Hormone
    • TIBC
    • Tobramycin
    • Total T3
    • Total T4
    • Transferrin
    • Triglycerides
    • Urea
    • Uric Acid
    • Vitamin B12
    • Zinc

    Laboratory Quality Control

    Why choose Randox Acusera?

    Regular shifts in QC results when a reagent batch is changed can be both costly and frustrating for many labs, resulting in a frequent need to reassign target values.

    Designed to be commutable, the Acusera range of Internal Quality Controls will react to the test system in a manner as close as possible to the patient sample helping you to meet ISO 15189:2012 requirements while ultimately ensuring accurate & reliable instrument performance. Furthermore, our lyophilized controls contain no added preservatives or stabilisers ensuring a sample matrix that closely matches the patient sample.

     

     

    Our extensive range of assayed quality controls are supplied with highly accurate target values for a wide range of instruments and methods. Our unique value assignment process utilises thousands of independent laboratories globally ensuring target values won’t change throughout the shelf life of the control and eliminates the need to spend time and money performing value assignment in-house.

    Accuracy coupled with unrivalled traceability to International Reference Laboratories, provides a product of unsurpassed accuracy and reliability.

    Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any lab – regardless of their size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189:2012 recommendations.

    ISO 15189:2012 states that the “use of independent third party control material should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”

    Read more about the benefits of third party controls here.

    We take quality seriously, that’s why all QC products are manufactured to the highest possible standard delivering control products of unrivalled quality. Our superior manufacturing processes ensure stability claims and analyte levels won’t differ significantly from lot to lot. You can therefore be sure of receiving the same standard of product time and time again.

    Traceability refers to the property of a measured result or calibrator value to be related or traced back to a reference measurement procedure or reference material through a series of measurements with known uncertainties.

    The European parliament and council directive 98/79 EC require values assigned to both calibrators and control materials on in vitro diagnostic medical devices to be traceable to a recognised reference material or reference measurement procedure of higher order, e.g. SI units.

    Guidelines have been set for diagnostic manufacturers to follow when assigning calibrator values and establishing traceability. These guidelines were set by the European standards EN/ISO 17511 and also EN/ISO 18153. The Randox traceability pathway has been established with reference to standards ISO 17511 and ISO 18153. The pathway has been followed to establish traceability for Randox calibrators allowing all patient results to be traced right back to the source.

    Randox is a leading provider of multi-analyte, third party controls designed to allow any lab to carry out highly accurate QC using fewer controls. In  an industry where budgets and resources are increasingly under pressure, highly consolidated controls will ensure high levels of throughput without compromising on accuracy. Uniquely comprising up to 100 analytes in a single control product, costs, preparation time and storage space are dramatically reduced without sacrificing on quality.

    The presence of analytes at key decision levels in all Acusera controls will not only ensure accurate test system performance across the clinical range, but will further aid consolidation and maximise laboratory efficiency by eliminating the need to purchase additional high or low level controls, which are often expensive.

    Available in multiple levels, the Acusera range of third party controls are designed to challenge laboratory instruments throughout the patient reportable range.  The presence of analytes  at clinically relevant decision levels not only helps to ensure accurate instrument performance but maximizes laboratory efficiency by eliminating the need to purchase additional low/high concentration controls at extra expense.

    Randox also employs easy to use colour-coded packaging to help distinguish between different levels and reduce costly mix-ups.

    ISO 15189:2012 states, “The laboratory should choose concentrations of control materials wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”.

    Working stability and product shelf life are important considerations for any lab when choosing which internal quality control material is best suited to their needs. Labs often spend up to one month validating new material, a process which can be minimised by opting for a control with an extended shelf life. At Randox our lyophilised controls have a shelf life of up to four years and our liquid controls a shelf life of up to two years from the date of manufacture ensuring continuity of lot supply and ultimately reducing the need for expensive new lot validation studies.

    Each of our third party controls will have its own reconstituted or open vial stability, some of the analytes will have limitations, however we pride ourselves on not misleading customers with false claims. The extended open vial and reconstituted stabilities will help laboratories to minimise waste and reduce costs.

    With an extensive range of assayed/unassayed, liquid/lyophilised and single/multi-analyte controls, the Acusera portfolio has a solution to suit all laboratory preferences.

    Custom Controls
    Randox is a market leader in the manufacture of customised quality controls designed to meet the individual and unique requirements of even the most specialised laboratories.

    Find out more about custom controls

    Acusera Range of Quality Controls

    With over 390 parameters available in our Acusera Internal Quality Control range, choice and flexibility is guaranteed.




    About Randox QC

    Laboratory Quality Control is our passion and with more than 30 years’ experience developing Laboratory Quality Control for the in vitro diagnostics market we believe in producing high quality material designed to streamline procedures, whilst reducing costs in laboratories of all sizes and budgets. These qualities have been reflected in our Acusera true third party quality controls, Acusera 24.7 interlaboratory data management software and RIQAS EQA scheme.

    Randox is one of the largest manufacturers of true third party quality control solutions delivering reliable, high quality products designed to accurately assess instrument performance and ultimately provide confidence in patient test results. With more than 390 analytes available across the Acusera range and a wide range of formats providing flexibility & choice, we have a solution to suit you.

     


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