Serum Indices Quality Control

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Serum Indices Quality Control

Therapeutic Drug Quality Control

The Randox Acusera Serum Indices control is designed to be used to monitor an IVD instrument’s response in the detection of haemolyzed, icteric and lipemic (HIL) samples. This control can be utilised in laboratory interference testing to assist in improving error detection of pre-analytical errors affecting clinical chemistry testing.

This control provides a full range of clinically relevant testing levels.

Features & Benefits

  • Lyophilised for enhanced stability
  • Manufactured using human serum, ensuring commutable sample matrix
  • 2-year shelf life from date of manufacture
  • True third party control providing unbiased assessment of performance
  • Reconstituted stability of 14 days at 2°C – 8°C
DescriptionSize AnalytesCat No 
Serum Indices Control4 x 5 ml3SI10448

Analytes

  • Haemolysis (H)
  • Icterus (I)
  • Lipemia (L)

Cardiac Quality Control

Therapeutic Drug Quality Control

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

This control provides a full range of clinically relevant testing levels, including High Sensitivity Troponin I.

Features & Benefits

  • Liquid for ease-of-use stability
  • Aqueous Material
  • 4 Clinically relevant levels (including Ultra-Low)
  • Stable to expiry date at -18-24ºC storage
  • Thawed stability of 7 days at 2°C – 8°C
DescriptionSize AnalytesCat No 
Cardiac Control - Ultra Low3 x 3 ml2CQ10453
Cardiac Control Level 13 x 3 ml2CQ10454
Cardiac Control Level 23 x 3 ml2CQ10455
Cardiac Control Level 33 x 3 ml2CQ10456

Analytes

  • Troponin I
  • NT-proBNP

Neonatal Bilirubin External Quality Assessment

The RIQAS Neonatal Bilirubin EQA programme has been designed to assess the performance of total and direct bilirubin assays with levels tailored to neonatal bilirubin testing.

  • Lyophilised for enhanced stability
  • Monthly reporting
  • Human based serum
  • Submit results and view reports online via RIQAS.net
  • Rapid turnaround of reports allows for any necessary corrective actions to be taken with minimal disruption to laboratory output

Not accredited to ISO/IEC 17043

Cat NoKit SizeFrequencyCycle StartParameters 
RQ91912 x (6x3ml)MonthlyJuly2

Parameter

  • Direct Bilirubin
  • Total Bilirubin

Please note, product availability may vary country to country.


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 Driect and Total Bilirubin. With a 14 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 14 days at 2°C – 8°C
  • Assayed Control
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


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 for ease-of-use 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

Linearity Verifier Sets

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Challenge your Instrument Throughout the Reportable Range with Acusera Linearity Verifier Sets

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    Complimentary data reduction software is provided delivering an immediate indication of performance.
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    Samples are provided in a user-friendly format with both liquid and lyophilised options available.
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    An extended open vial stability keeps waste to a minimum and ensures availability of product for troubleshooting.
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    Supplied in a minimum of 5 levels to accurately challenge the AMR and remove the need for manual dilution.
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    Ensure specific instrument requirements are met with the availability of dedicated solution for both Roche Cobas and Beckman systems.
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    Multi-analyte calibration verifiers will reduce costs, storage space and the number of products required to cover your test menu.
Solutions for Roche Cobas Analysers

 

Solutions for Beckman Analysers

 

Calibration verification or linearity assessment is defined as the testing of materials of known concentration in the same manner as patient specimens to ensue the test system is accurately measuring samples throughout the reportable range.

CLIA recommend calibration verification once every six months and/or in the event of; a reagent lot change, major preventative maintenance, replacement of critical parts, when QC materials are outside acceptable limits or reflect an unusual trend and as part of new instrument validation.

Our Acusera range of instrument dedicated verifiers are designed to challenge the entire analytical measuring range whilst helping to meet the CLIA requirements. Our range covers Clinical Chemistry, Bilirubin, Apolipoproteins, Enzymes, CRP, Esoterics, Lipids, TDM‘s and more.

Quality Control

Resource Hub

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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

RIQAS Point of Care EQA

RIQAS Point of Care EQA Logo

Randox International Quality Assessment Scheme – Point of Care EQA

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Designed to improve the quality of Point of Care Testing (POCT) in locations such as pharmacies, GP surgeries, hospital out patient departments, sports clinics, supermarkets, diagnostic/treatment and walk-in centres, RIQAS Point of Care EQA provides independent evidence of the accuracy and reliability of test results. Randox International Quality Assessment Scheme (RIQAS) is the world’s largest EQA scheme with over 47,000 participants in more than 139 countries.

Why RIQAS Point of Care?

About RIQAS Point of Care

  • How it Works

    On a monthly basis we will distribute an identical sample of blood to all participating sites.  Each participating site will test the sample in the same way they would test a real patient sample, then return their test results to RIQAS within a set time. The scheme is unique in distributing whole blood samples rather than serum based samples, this ensures that samples act identically to real patient samples at the point of care.

    An electronic report is then sent to participants, comparing their results with other participants using the same analyser.  Satisfactory and unsatisfactory performance is represented using a traffic light system, allowing instant identification of any issues. A more detailed breakdown of performance may be obtained if further information is required. With time, an overall picture will emerge showing whether results are consistently accurate and reliable or whether there may be an underlying analyser and/or operator issue.

    RIQAS Point of Care - How it works
  • Tests and Analysers

    Test Role
    HbA1c • Diagnosing diabetes mellitus
    • Monitoring treatment
    • Encouraging self-management
    Total Cholesterol & HDL Cholesterol • Risk factors for heart disease
    • Monitoring lipid lowering therapy
    C-Reactive Protein (CRP) • Early detection of infectious disease
    • Identifying need for antibiotic treatment
    Glucose • Diagnose and monitor diabetes
    • Monitor for the presence of hypoglycaemia
    (low blood glucose) and hyperglycaemia (high blood glucose)
    International Normalised Ratio (INR) • Used to measure the effect of anticoagulant
    drugs such as warfarin
    • Help diagnose a bleeding disorder; to help
    estimate the severity of liver disease
    Ketones • To determine whether excessive ketones are
    present in the blood, to detect diabetic
    ketoacidosis (DKA)
    Note – The RIQAS Point of Care range is constantly expanding to include new tests and analysers. Please contact us if your desired analyser or test is not currently displayed.
  • Ordering Information

    Panel Catalogue Number
    Lipids RQ9181/A
    Lipids + 1 panel RQ9181/B
    Lipids + 2 panels RQ9181/C
    Additional Sample RQ9181/D
  • What Participants Say

    Our unrivalled commitment to quality and service ensures high levels of customer satisfaction, this is evident from the responses to our latest customer satisfaction survey:

    “All in all a quick and efficient service”
    “Good online system”
    “Very helpful team”
    “Excellent training”
    “They are an experienced team”
    “Very satisfied with the service that we receive”
    “Very good value for money”
    “The website is great”
  • Distribution Dates

    Distribution Month Sample Distributed Result Submission Deadline
    January 2021 11th January 20th January
    February 2021 1st February 10th February
    March 2021 1st March 10th March
    April 2021 5th April 14th April
    May 2021 3rd May 12th May
    June 2021 7th June 16th June
    July 2021 5th July 14th July
    August 2021 2nd August 11th August
    September 2021 6th September 15th September
    October 2021 4th October 13th October
    November 2021 1st November 10th November
    December 2021 6th December 15th December
  • Importance of Quality Assurance

    Quality assurance is an essential aspect of any clinical/diagnostic testing service and is aimed at ensuring the accuracy and reliability of patients’ results. The right result allows the right clinical advice to be offered in a timely manner. Quality assurance operates at two levels:

    Internal Quality Control

    Internal Quality Control includes operator training/ competency assessment, analyser/ test system maintenance, and adherence to policies/ processes. Whilst some point of care analysers include inbuilt quality checks, cross-check analysis against samples with known levels provides immediate assurance and evidence that a patient’s result is safe to report.

    External Quality Assessment

    External Quality Assessment involves analysis of samples with unknown levels that have been distributed by an external organisation. Participants are informed how their results compare with other participants, hence providing independent evidence of performance. Increasingly, participation in an external quality assessment scheme is becoming a mandatory requirement where health and healthcare services are being provided.

    EQA provides assurance to both staff and customers that testing provides accurate and reliable results.

    Want to know more?

    Visit our Importance of EQA page to learn more.

Want to know more?

Contact us or download the RIQAS Point of Care catalogue to learn more.

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