Randox is a leading provider of true third party quality controls for laboratories. Their controls offer the most accurate target values based on data from over 23,000 labs, the most consistent material between lots, and unrivalled stability that meets or exceeds claims. Many controls are 100% human material, important for immunoassay methods. As true third party controls, they provide an unbiased assessment of performance across different instruments and methods, reducing the need for multiple controls. Randox controls also allow for consolidation, reducing the number of individual controls required through their wide coverage of analytes.

1. “revolutionising healthcare through continuously
improving diagnostic solutions”

3. WORLD LEADING PROVIDER OF
TRUE THIRD PARTY CONTROLS

4. Randox cusera
• Leading manufacturer of true third party control
materials supplying over 30,000 laboratories
worldwide
• Flexible product range covering over 350 routine and
esoteric analytes
• Choice of liquid or lyophilised controls depending on
customer requirements
• Largest manufacturer of customised quality controls

5. Benefits of Randox Controls
•
Most accurate controls available
– Target values based on data from over 23,000 independent laboratory
participants
•
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
•
100% human material
– Vital for antibody based methods
•
True third party controls
– Provide an unbiased, independent assessment of performance
– Can be used with many different instruments and methods
– Reduce the need for multiple instrument specific controls
•
Consolidation

6. The Most Accurate Target Values
• Unique value assignment process
– Target values generated from thousands of independent
labs resulting in highly accurate multi-method and multianalyser data
• Traceability to reference methods
– Reference method values provided for 12 analytes in our
assayed chemistry control

7. The Most Consistent Material
• Minimal variation between lot numbers
– Target values and stability claims will not differ
significantly between lots
– Randox manufacture to extremely tight
specifications resulting in limited variation
between lots

8. The Most Stable Material
• Extended shelf life
– Randox lyophilised controls have a shelf life of up to 4 years from the
date of manufacture while our liquid controls generally have a 2 year
shelf life
– Ensures continuity of lot supply
– Reduces time spent re-assigning values when lots change
• Excellent reconstituted/open vial stability
– Reduces waste and costs
• Stability claims are always met
– Extensive validation and shipping studies performed
– Randox controls will meet and often exceed the stability claims made

9. The Highest Quality Material
• Source of the raw material
– Sourced from the UK Blood Transfusion Service and screened for a
wide range of infectious diseases
– Integrity of the base material is critical in producing high quality, stable
controls
• Superior manufacturing processes
– QC sera is filtered down to 0.2 micron ensuring minimal bacterial load
– As an ISO accredited manufacturer we adhere to a strict
manufacturing regime
• No preservatives in lyophilised controls
– Mirrors the performance of a patient sample

10. 100% Human Material
All Randox controls for use with
immunoassay/immunology based methods
are manufactured from 100% human
material

11. Importance of 100% Human Controls
• 100% human controls are essential for immunoassay
based methods where the reagents contain human
antibody
– Creates a matrix similar to the patient sample
– Reduces antibody cross reactivity and the risk of control
values shifting when reagent batch is changed
• If not managed effectively, lot-to-lot variation can be a
significant source of analytical error, particularly where
– Very low concentrations of an analyte are being reported
as clinically significant
– Reference range is very narrow

12. Importance of 100% Human Controls
• Many immunoassay controls on the market contain constituents of animal
origin meaning they behave differently to patient samples
• The inclusion of such non-human components creates problems with
antibody based tests
• Different batches of reagent are likely to have been manufactured with
different batches of antibody
• The non-human components in the control will react very differently with
each different lot of antibody resulting in significantly large shifts in values
when reagent batch is changed
• Such shifts lead to a frequent need to reassign control materials causing
frustration and an increase in costs

13. Third Party Controls
• The Randox Acusera range of controls are designed for use
with many different instruments and methods
• Provide an independent, unbiased assessment of
performance
• Reduce the need for multiple instrument/platform specific
controls
• Saves time and money
• One vendor = fewer orders to place and have approved

14. Importance of Third Party Controls in Detecting
Errors within the Laboratory
The following real life case studies highlight the
importance of third party controls in detecting
instrument, reagent and procedural errors within
the laboratory
If these labs had not been running a third party control
alongside their instrument/reagent manufacturers control the
underlying issue may have gone unnoticed and incorrect patient
results could have been released.

15. Third Party QC Real Life Case Studies –
Lab A
• A laboratory using the reagent manufacturers dedicated QC alongside
their Bilirubin reagent found the assay to be working fine with results
within the ranges provided on the pack insert
• They also ran our Assayed Chemistry Premium Plus control alongside
the instrument control however this time the results reported were
approximately 25% low to target
• They proceeded to contact the Randox technical support team who
provided them with some EQA samples. As suspected results for these
samples were also 25% lower than expected
• Further investigations confirmed the low results were due to an
instrument fault which their instrument dedicated control failed to
detect

16. Third Party QC Real Life Case Studies –
Lab A
• Conclusion
– The use of Randox third party controls led to
the identification of an instrument fault that
could have potentially affected the patient
results released from that laboratory. The
dedicated control supplied by the reagent
manufacturer failed to detect this problem.

17. Third Party QC Real Life Case Studies
– Lab B
•
A laboratory using the Randox Immunoassay Premium Plus
control reported their QC results for Thyroglobulin were 4
times higher on their main analyser compared to other
systems
•
They ran the instrument dedicated control alongside the
Randox control however it did not show the same problem
•
After reviewing EQA data for their instrument the Randox
technical support team confirmed there was a significant
difference in results compared to other instruments
•
The customer contacted their instrument manufacturer who
advised of a positive bias with several batches of reagent

18. Third Party QC Real Life Case Studies
– Lab B
• Conclusion
– The Randox Immunoassay control detected a
shift in results that the instrument
manufacturers control did not. If undetected
this shift could have led to the release of
incorrect patient results.

19. Consolidation
• Randox controls contain a unique combination of analytes
• Our range of multi-analyte controls cover up to 100
analytes in a single vial
• Reduce the number of individual controls required
–
–
–
–
Fewer orders to manage
Less handling therefore reduction in errors
Fewer controls to prepare thus increased efficiency
Fewer controls to monitor and track expiry dates
Less is More!

20. Consolidation
• Randox controls will cover clinically significant
concentrations
– Eliminating the need for additional low/high level
controls at extra expense to the laboratory
• Many competitors market separate controls
for low analyte levels

21. Consolidation Real Life Examples – Lab A
Competitor
Randox
Chemistry Control
Liquid 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
Total saving - £16,046.60

22. Consolidation Real Life Examples – Lab B
Competitor Controls
Randox Controls
Chemistry Control Level 1
Liquid Chemistry Premium Plus Control L1
Chemistry Control Level 2
Liquid 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
Total saving - £8971

23. Acusera Product Portfolio
•
•
•
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•
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Clinical Chemistry
Immunoassay
Immunology
Cardiac Markers
Lipids
Speciality and Research
•
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•
•
Diabetes
Urine Chemistry
Coagulation
Blood Gas
Therapeutic Drugs

24. Liquid Assayed Chemistry Premium
Plus
• Liquid for ease of use and convenience
• Covers 100 analytes in a single vial allowing for
effective consolidation and cost savings
• Assayed instrument and method specific target values
provided
• Three clinically significant levels available
• High levels of CRP and other proteins

25. Immunoassay Premium Plus
• Contains 54 analytes, including the routinely run tumour
markers CA15-3, CA19-9, CA-125, AFP, CEA, PSA and free PSA
• Includes Ferritin and Vitamin B12 levels suitable for anaemia
monitoring
• 100% human serum
• Reconstituted stability of seven days at 2-8oC or 28 days at 20oC
• Dramatically reduces costs as there is no need to purchase up
to four separate controls to monitor tumour markers,
anaemia or intact PTH

26. 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
• 100% human serum
• Liquid ready-to-use requiring no preparation
• Open vial stability of 30 days at 2-8oC minimises waste and
helps to keep costs low
• This unique combination of analytes allows for effective
consolidation and significant cost savings

27. Liquid Cardiac Control
• Contains target values for an impressive 9 different analytes,
including Troponin I and T, D-dimer and homocysteine
• 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
• 100% human serum
• Liquid ready-to-use requiring no preparation
• Open vial stability of 30 days at 2-8oC for all analytes keeps
waste to a minimum

28. Customised Quality Control
• Some laboratories may require something
specific to meet their needs
• In this case we can offer a custom made
serum allowing laboratories to
– Add or remove analytes
– Choose analyte levels
– Choose vial sizes

29. Benefits to your Laboratory
• Consolidation
– Saves time and money
• Flexibility
– Opportunity to specify exactly what you require
• Quality product
– Custom made process is transparent
– Value for money

30. Summary
•
Most accurate controls available
– Target values based on data from over 23,000 independent laboratory
participants
•
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
•
100% human material
– Vital for antibody based methods
•
True third party controls
– Provide an unbiased, independent assessment of performance
– Can be used with many different instruments and methods
– Reduce the need for multiple instrument specific controls
•
Consolidation

31. Contact Us
Acusera@randox.com
Visit our website
www.randox.com

32. “revolutionising healthcare through continuously
improving diagnostic solutions”