Liquid Bilirubin Control

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Liquid Bilirubin Control

Therapeutic Drug Quality Control

Providing a true third party solution for the measurement of Bilirubin, the new Acusera Liquid Bilirubin Control is designed to deliver an unbiased, independent assessment of analytical performance helping to ensure accurate and reliable patient testing.

Two levels are available, covering the required clinically relevant decision levels for neonatal testing of Direct and Total Bilirubin. With a 7 day open vial stability and 2 year shelf life the Acusera Liquid Bilirubin Control will reduce waste, whilst remaining easy and convenient to use.

Features & Benefits

  • Liquid frozen
  • 100% human serum
  • 2 year shelf life from date of manufacture
  • Clinically relevant decision levels, recommended by ISO15189
  • Open vial stability of 7 days at 2°C – 8°C
  • Assayed Control
  • CE Marked
DescriptionSizeAnalytesCat No.
Liquid Bilirubin Control Level 13x3mLDirect Bilirubin
Total Bilirubin
BR10442
Liquid Bilirubin Control Level 23x3mLDirect Bilirubin
Total Bilirubin
BR10443

 

Analytes

  • Direct Bilirubin
  • Total Bilirubin

Related Products


Randox Quality Control launches new Acusera D-Dimer Controls

Randox Quality Control launches new Acusera D-Dimer Controls

16 March 2021: Randox Quality Control launches new Acusera D-Dimer Controls

Randox Quality Control has launched a new range of Acusera Controls for the accurate and reliable testing of D-Dimer.

Providing a true third-party solution for D-Dimer testing, which is most often used to investigate whether a patient has a blood clotting disorder, this control is manufactured for use on a range of different diagnostic systems.

Designed to provide accurate and reliable patient testing, this control comes in a liquid frozen format and is stable for an impressive 28 days when stored at 2ºC to 8ºC.

Three levels are supplied, spanning the full clinical range and FEU.

Features and Benefits

  • Liquid frozen
  • 100% human serum
  • 2 year shelf life from date of manufacture
  • Cut-off level of 500 ng/ml (FEU) for most analysers
  • Open vial stability of 28 days at 2°C – 8°C
  • Assayed Control

For more information visit https://www.randox.com/d-dimer-internal-quality-control/

 

 

QUALITY CONTROL

REAGENTS

RX SERIES


Troponin T Quality Control

Therapeutic Drug Quality Control

Intended for use with the Roche system, this control is manufactured using only the highest quality material and offers an unrivalled 7-day thawed stability at +2ºC to +8ºC.

Features & Benefits

  • Liquid frozen for enhanced stability
  • Aqueous based material
  • Ultra low levels of Troponin T
  • Stable to expiry date at -18-24ºC storage
  • Thawed stability of 7 days at 2°C – 8°C
DescriptionSize AnalytesCat No
Troponin T Control6 x 3 ml1CQ10450

Analytes

  • Ultra low Troponin T

Bilirubin Linearity Verifier

Therapeutic Drug Quality Control

Our Bilirubin verifier contains both Direct Bilirubin and Total Bilirubin so testing is fully covered. Dedicated for use on Roche
Cobas systems, this verifier spans five levels ensuring the instruments entire reportable range is measured.

Features & Benefits

  • Lyophilised for enhanced stability
  • 5 levels provided
  • Open vial stability of 10 days at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No
Acusera Enzyme Linearity Verifier5 x 3mL10LV10366

Analytes

  • Direct Bilirubin
  • Total Bilirubin

Enzyme Linearity Verifier

Therapeutic Drug Quality Control

Our Enzyme Linearity Verifier contains 10 commonly tested enzymes in one unique multi-marker verifier allowing you to
consolidate testing. Spanning 5 clinical levels, this verifier ensures the systems entire reportable range is measured. Designed
specifically for use with Roche Cobas systems, our Verifier is available in a convenient liquid frozen format.

Features & Benefits

  • Convenient, liquid frozen format
  • 5 levels provided
  • 14 day stability when stored at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No
Acusera Enzyme Linearity Verifier5 x 3mL10LV10366

Analytes

  • ALT
  • ALP
  • a-Amylase
  • Pancreatic Anylase
  • AST
  • CK
  • CKMB
  • yGT
  • LDH
  • Lipase

Clinical Chemistry Linearity Verifier

Therapeutic Drug Quality Control

Our Clinical Chemistry Linearity Verifier comprises 17 common chemistry assays, supplied in a liquid frozen format. Designed specifically for use on Roche Cobus analysers, this verifier spans five levels ensuring the instruments entire reportable range is measured.

Features & Benefits

  • Convenient, liquid frozen format
  • 5 levels provided
  • 7 day stability when stored at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No
Acusera Verify Clinical Chemistry Linearity Verifier5 x 5mL17LV10390

Analytes

  • Albumin
  • BUN
  • Calcium
  • Chloride
  • Creatinine
  • Glucose
  • Iron
  • Lactate
  • Lithium
  • Magnesium
  • Phosphate
  • Potassium
  • Sodium
  • Total Protein
  • Triglycerides
  • Uric Acid
  • Total Cholesterol

Ethanol Calibrator/Control Set

Therapeutic Drug Quality Control

Dedicated calibrator and control set designed for the calibration and quality control of the Randox Ethanol assay.

Features & Benefits

  • Liquid ready-to-use
  • Human urine
  • Stable to expiry date when capped and stored at 2oC – 8oC
  • Open vial stability of 28 days at 2oC – 8oC
DescriptionSizeAnalytesCat No
Ethanol Calibrator/Control Set4 x 10ml1DA2703

Analytes

Ethanol


Acusera Lipids Linearity Verifier

Therapeutic Drug Quality Control

Our Lipids Linearity Verifier comprises 3 common lipid assays and is specifically designed for use on Beckman Coulter
analysers. Five levels are available spanning the instrument’s complete reportable range. Designed in a liquid frozen format,
this linearity verifier will objectively verify calibration of the instrument whilst remaining convenient and easy to use.

Features & Benefits

  • Convenient, liquid frozen format
  • 5 levels provided
  • 14 day stability when stored at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No
Acusera Lipids Linearity Verifier5 x 3mL3LV10364

Analytes

  • HDL Cholesterol
  • LDL Cholesterol
  • Triglycerides

Acusera Apolipoprotein A-1 (Apo A-1) & Apolipoprotein B (Apo B) Linearity Verifier

Therapeutic Drug Quality Control

Dedicated Linearity Verifier for measuring Apo A-1 and Apo B on Beckman Coulter analysers. Spanning 5 levels designed to
challenge the instruments reportable range, this verifier will objectively verify calibration of the instrument whilst remaining
convenient to use.

Features & Benefits

  • Convenient, liquid frozen format
  • 5 levels provided
  • 14 day stability when stored at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No
Acusera Apolipoproteins Linearity Verifier5 x 3mL2LV10363

Analytes

  • Apolipoprotein A-1 (Apo A-1)
  • Apolipoprotein B (Apo B)

Randox launches new Acusera Verify linearity sets for Roche Cobas and Beckman systems

Randox Quality Control is set to launch new Acusera Verify linearity sets at the American Association for Clinical Chemistry 2019.

Randox Linearity sets are designed to challenge a larger segment of an instrument’s reportable range, and test validity of system calibration. The Acusera Verify materials will cover testing of C-reactive Protein, Rheumatoid Factor, Lipids, Therapeutic Drugs, and Esoterics, amongst others and are compatible for use with Roche Cobas and Beckman systems.

Materials also include a unique combination of analytes, meaning laboratories do not need multiple products for testing, which reduces both costs and need for storage space.

Lynsey Adams, Randox Quality Control Manager, commented;

“Acusera Verify’s range of instrument-dedicated calibration verifiers are designed to challenge the entire Analytical Measuring Range, whilst remaining convenient to use and helping to meet Clinical Laboratory Improvement Amendments (CLIA) requirements.”

According to CLIA, a laboratory should perform and document calibration verification procedures at least once every 6 months and/or whenever one of the following occur;

  • A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range.
  • There is a major preventive maintenance or replacement of critical parts that may influence test performance.
  • Control material reflects an unusual trend or shift, or are outside of the laboratory’s acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.
  • Laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.
  • New instrument validation.

CLIA also recommends that a minimum of 3 levels are tested covering the low end, mid-point and high end of the reportable range. The Clinical and Laboratory Standards Institute (CLSI) however, recommend at least 5 levels are tested. It is also considered best practice that laboratories run at least 3 replicates of each level in the same way they would a patient or control sample.

Acusera Verify from Randox QC will ensure that laboratories meet the recommended CLIA and CLSI guidelines in both a timely and costly manner.

Randox Linearity sets available:

  • C-Reactive Protein (CRP) Linearity Verifiers
  • High Sensitivity C-Reactive Protein (hsCRP) Linearity Verifier
  • Esoterics Linearity Verifier
  • Rheumatoid Factor (RF) Linearity Verifier
  • Lipids Linearity Verifier
  • Apolipoprotein A1 (Apo A1) & Apolipoprotein B (Apo B) Linearity Verifier
  • Therapeutic Drug Monitoring (TDM) Linearity Verifier
  • CO2 and Electrolytes Linearity Verifier

Acusera Verify also allows users to access real-time peer group data and automatically-generated statistics through a cloud-based data reduction software package which is supplied with all linearity sets. This provides laboratories with comprehensive graphs of results and at-a-glance performance assessment.

For further information please email acusera@randox.com, visit www.randoxqc.com or tel: +44 (0) 28 9442 2413 / fax: +44 (0) 28 9445 2912

 


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