Randox QC offer an extensive range of third party quality controls. Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2012 requirements whilst simultaneously eliminating the need for multiple instrument dedicated controls.

1. Randox Quality ControlThird Party 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
• Cost Effective
― 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 Immunoassay Premium 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 Liquid Assayed 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 – Clinically Relevant 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 – Clinically Relevant 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 – Clinically Relevant 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
• Accurate target 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
• Consistent from 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 Maintain ISO 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 analyte menu covering over 350 routine and specialised
parameters
• Choice of
―Assayed/Unassayed controls
―Liquid/Lyophilised controls
―Human/Bovine controls

20. Assayed Chemistry Premium Plus
• 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 accurate controls 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

25. Thank You