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Acusera Third Party Controls
Randox is a leading manufacturer of quality control materials, providing true third-party controls to over 60,000 laboratories worldwide. They offer a flexible range of products covering more than 350 analytes, emphasizing cost-effective solutions through consolidation of controls, which enhances efficiency and accuracy in labs. Key benefits include high-quality, accurate target values, commutability, and long shelf life, which support compliance with ISO 15189 standards.
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Acusera Third Party Controls
- 1. Randox Quality ControlThirdParty Controls
- 2. Who are we? •Leading primary manufacturer of true third party control materials supplying over 60,000 laboratories worldwide • 3rd largest manufacturer of QC and calibrators globally • Flexible product range covering over 350 routine and esoteric analytes • World’s leading supplier of QC material to PT schemes globally • World’s largest PT provider globally • Choice of liquid or lyophilized controls depending on customer requirements • World’s largest manufacturer of customized quality controls
- 4. • Clinical Chemistry •Immunoassay • Immunology/Proteins • Cardiac Markers • Haematology • Coagulation • Urine Chemistry • Drugs of Abuse • Therapeutic Drugs • Tumour Markers • Maternal Screening • Lipids • HbA1c • Blood Gas • Speciality/Research • POC The Acusera QC Range
- 5. Key Benefits • CostEffective ― Consolidation ― Clinically significant levels ― Reduced waste • High Quality ― Accurate ― True third party ― Commutable ― Consistent ― Material and Manufacturing • Flexibility ― Extensive analyte menu ― Variety of formats Cost Effective + High Quality + Flexibility = Increased Efficiency and Accuracy
- 6. Cost Effective –Consolidation • Where previously large multifunctional laboratories may have had to routinely run >30 controls it is now possible to produce highly accurate results using 10 or less Randox controls • Our unique combination of analytes allows for effective test menu consolidation without compromising on quality • Our range of multi-analyte controls cover up to 100 analytes in a single vial • By reducing the number of individual controls used you can significantly increase productivity and reduce costs while benefiting from: ― Fewer orders to manage ― Reduced preparation time ― Minimal sample handling ― Fewer controls to monitor and track expiry dates Less is More!
- 7. Consolidation with ImmunoassayPremium Plus • The Randox Immunoassay Premium plus control covers up to 54 analytes in total - Routine tumour markers CA15-3, CA19-9 and CA125 not present in the competitor IA controls - Clinically relevant levels of TSH, Ferritin and Vitamin B12 replacing the need for a separate Anaemia control - Extensive range of therapeutic drugs - Additional benefits include; 100% human serum, Assayed target values Labs may be using 4 or more competitor controls to cover what is included in just 1 Randox control
- 8. Consolidation with LiquidAssayed Chemistry Premium Plus • Combines 99 analytes including lipids, proteins, routine immunoassay, cardiac markers, therapeutic drugs and electrophoresis • Eliminates the need for six or more individual controls Labs may be using 6 or more competitor controls to cover what is included in just 1 Randox control
- 9. Cost Effective –Consolidation • Randox controls will cover clinically significant concentrations ―Many analytes present at clinical decision levels ―Eliminates the need for additional low/high level controls at extra expense ―Recommended by ISO 15189 • Many competitors market separate controls for low analyte levels ―This not only increases preparation time but can have significant cost implications “The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical decision values , which ensure the validity of decisions made” ISO 15189 5.6.2.2
- 10. Consolidation – ClinicallyRelevant Levels Comparison of the Randox Immunoassay Premium Plus and a competitors Immunoassay control shows that: • Competitor 1 does not cover the 0.1 uU/ml decision level for TSH. Values are within the normal range 0.4-0.5 • Competitor 1 does not cover the 190pmol/l decision level for Vitamin B12 • Ferritin levels in the Competitor 1 level 1 control are too high • Competitor 1 does not cover the 3mIU/l decision level for insulin
- 11. Consolidation – ClinicallyRelevant Levels The Liquid Chemistry Premium Plus control contains high levels of CRP and other proteins eliminating the need for a separate protein control.
- 12. Consolidation – ClinicallyRelevant Levels • New high sensitivity troponin assays allow for earlier detection of troponin in the blood allowing for early rule out • Demand for lower troponin levels to ensure accurate instrument performance at such highly sensitive levels Randox L1 Competitor L1 Analyte Units 3833CK 3909CK 3910CK Mean Analyte Units 29831 29841 29851Mean Troponin I ng/ml 0.089 0.03 0.086 0.07Troponin I ng/ml 1.21 1.76 0.68 1.22
- 13. Cost Effective –Consolidation Competitor Randox Chemistry Control Assayed Chemistry Premium Plus Immunology Control Competitor Randox Immunoassay Control Immunoassay Premium Plus Tumour Marker Control 1 Immunoassay Speciality Tumour Marker Control 2 Speciality Control Vitamin D Control Anti-TPO Control Low Testosterone Control 9 competitor controls consolidated to just 3 Randox controls
- 14. Cost Effective –Consolidation Competitor Controls Randox Controls Chemistry Control Level 1 Assayed Chemistry Premium Plus Control L2 Chemistry Control Level 2 Assayed Chemistry Premium Plus Control L3 Immunology Control Level 1 Custom RF + CRP Control Immunology Control Level 3 Bile Acids Control Level 1 Bile Acids Control Level 2 Lipid Control Level 1 Lipid Control Level 3 Troponin Level 1 Troponin Level 2 Competitor Controls Randox Controls Anaemia Control Level 1 Immunoassay Premium Plus L1 Anaemia Control Level 2 Immunoassay Premium Plus L3 Tumour Marker Control Level 1 Tumour Marker Control Level 2 TDM Control Level 1 TDM Control Level 2 16 competitor controls consolidated to just 5 Randox controls
- 15. High Quality • Accuratetarget values ― Unique value assignment process employing over 40,000 independent labs ― Ensures availability of data for multiple methods and instruments ― Statistically valid ― Unlike some competitor controls target values won’t shift throughout the shelf life • True third party ― Deliver unbiased performance assessment ― Availability of target values for a wide range of instruments ― Eliminates the need for multiple instrument specific controls ― Recommended by ISO 15189 • Commutable ― QC samples will behave in the same manner as the patient sample ― 100% human samples for immunoassay methods eliminating QC shifts when reagent batch is changed ― Vital when validating new batches of reagent ― Ensures minimal lot to lot variation ― Recommended by ISO 15189 Ensure complete confidence in routine testing
- 16. Benefits of commutability •Most labs will be experiencing shifts in QC target values when they change batch of reagent – especially with Immunoassay tests • By using a commutable control laboratories could - Reduce the need to re-assign QC target values when reagent batch is used - Reduce labour - Reduce costs of QC - Reduce reagent wastage - Reduce troubleshooting - Improve confidence that test system is performing accurately - Meet accreditation and regulatory requirements
- 17. High Quality • Consistentfrom lot to lot ― Possible due to our superior manufacturing processes and high quality base material ― Target values will not differ significantly between lots ― Stability claims will remain consistent from lot to lot unlike some competitors • Stability ― Shelf life of up to 4 years for lyophilised controls and 2 years for liquid controls ― Ensures continuity of lot supply and reduces costly lot changes and validation studies ― Laboratories can use the same lot of control for longer ― The excellent working stability of our controls will also help to reduce costs and minimise waste • Traceability ― Traceable to international reference materials Ultimately ensures accurate test results with a reduction in costs and time due to fewer re-runs
- 18. Gain and MaintainISO Accreditation ISO 15189:2012 Requirements • Commutable controls (Acusera) ― “The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples” • True third party controls (Acusera) ― “Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer” • Clinically significant concentrations (Acusera) ― “The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical decision values , which ensure the validity of decisions made” • Interlaboratory data management (Acusera 24.7) ― “The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the quality control rules are violated ………the results shall be rejected and relevant patient samples re-examined” • External Quality Assessment (RIQAS) ― “The laboratory shall participate in an interlaboratory comparison programme(s) (such as an external quality assessment programme or proficiency testing programme)”
- 19. Flexibility • Extensive analytemenu covering over 350 routine and specialised parameters • Choice of ―Assayed/Unassayed controls ―Liquid/Lyophilised controls ―Human/Bovine controls
- 20. Assayed Chemistry PremiumPlus • Method and instrument specific target values available for 70 analytes ― Includes proteins, immunoassays, lipids, TDMs, cardiac markers, electrophoresis ― Reduces the need for multiple control products • Clinically significant osmolality values ― ~300 mOsm/kg in level 2 and ~ 370 mOSm/kg in level 3 ― Eliminates the need for additional control material • No added preservatives / stabilisers • Excellent working stability ― 7 days at 2oC to 8oC, extended to 4 weeks when stored at -20oC ― Minimises waste and reduces cost • Lyophilised for extended shelf life ― 4 year shelf life means the same lot can be used for longer
- 21. Immunoassay Premium Plus •Unique 100% human serum matrix ― The material behaves just like a sample patient ― No need to re-assign QC values when reagent batch is changed • Instrument specific target values for 54 analytes ― Including Tumour Markers, Hormones, Therapeutic Drugs and Vitamin D ― Significantly reduces the number of individual immunoassay controls required • Three clinically significant levels available ― Low levels of TSH, Ferritin and Vitamin B12 ― No need to purchase an additional low level control at extra expense • Excellent working stability ― 7 days at 2oC to 8oC, extended to 4 weeks when stored at -20oC ― Minimises waste and reduces cost
- 22. Specific Protein Control •Contains assayed target values and ranges for 27 serum proteins; including AFP, RF, Free Kappa Light Chain and Free Lambda Light Chain • Liquid ready-to-use requiring no preparation • Open vial stability of 30 days at 2oC to 8oC for all analytes minimises waste and helps to keep costs low • This unique combination of analytes allows for effective consolidation and significant cost savings
- 23. Liquid Cardiac Control •Contains target values for an impressive 8 different analytes, including Troponin I, Troponin T and D-dimer • Cut off levels for Troponin I and T are in line with internationally recommended levels • No need to purchase a separate control for D-dimer or separate low level controls for Troponin I and T • Liquid ready-to-use requiring no preparation • Open vial stability of 30 days at 2oC to 8oC for all analytes keeps waste to a minimum
- 24. Summary • Most accuratecontrols available ― Target values based on data from thousands of independent labs • Most consistent material ― Minimal variation in analyte concentration between lots • Unrivalled stability ― Will meet and often exceed stability claims • Highest quality material ― No added preservatives/stabilisers in our lyophilised material ― Most commutable material • True third party controls ― Provide an unbiased, independent assessment of performance • Consolidation ― Reduce the number of individual controls required
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