“revolutionising healthcare through continuously improving diagnostic solutions”

WORLD LEADING PROVIDER OF TRUE THIRD PARTY CONTROLS

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

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 – Reduce the number of individual controls required

The Most Accurate Target Values• Unique value assignment process– Target values generated from thousands of independent

labs resulting in highly accurate multi-method and multi-analyser data

• Traceability to reference methods– Reference method values provided for 12 analytes in our

assayed chemistry control

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

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

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

100% Human Material

All Randox controls for use with immunoassay/immunology based methods

are manufactured from 100% human material

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

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

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

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.

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

• 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.

Third Party QC Real Life Case Studies – Lab A

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

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.

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!

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

Consolidation Real Life Examples – Lab A Competitor Randox

Chemistry Control Liquid Assayed Chemistry Premium Plus

Immunology Control

9 competitor controls consolidated to just 3 Randox controlsTotal saving - £16,046.60

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

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 controlsTotal saving - £8971

Acusera Product Portfolio • Clinical Chemistry • Immunoassay • Immunology • Cardiac Markers• Lipids • Speciality and Research

• Diabetes• Urine Chemistry • Coagulation • Blood Gas • Therapeutic Drugs

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

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

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

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

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

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

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 – Reduce the number of individual controls required

Visit our website www.randox.com

Contact Us Acusera@randox.com

“revolutionising healthcare through continuously improving diagnostic solutions”