The Importance of Third Party Quality ControlsGet an unbiased, independent assessment of

analytical performance

QUALITY CONTROL

Quality Control

Quality control refers to the process of detecting analytical errors within the laboratory to ensure both the reliability

and accuracy of test results. Poor performance can result in misdiagnosis, delayed treatment, increased costs and

may even be potentially life threatening for the patient. Without good quality control, how can you be confident the

results you provide are accurate?

‘The purpose of quality control is to monitor the analytical quality of a procedure, detect changes and eliminate reporting results with medically important errors’ 11 Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the Quality and Productivity of Analytical Processes

Third Party Controls with an extended shelf life enable long term performance monitoring across multiple reagent batches

Year One Year Two Year Three

Instrument Manufacturer Reagent Batch 1 Batch 2 Batch 3

Instrument Manufacturer Control Lot 1 Lot 2 Lot 3

Randox Third Party Controls Lot 1

The Importance of Third Party Quality Controls

Third Party is the term used to describe a control that has

not been designed or optimised for use with a specific test

or system. As such they mirror the performance of patient

samples and provide an unbiased, independent assessment of

analytical performance.

• Randox true third party controls are manufactured

independently from our reagents and calibrators meaning

they can even be used with Randox reagents on the RX

series of analysers. Furthermore thousands of independent

laboratories are used during the value assignment process

with target values compared to reference methods to

ensure accuracy and reliability.

• With a shelf life of up to four years Randox controls enable

long term QC monitoring and the detection of shifts upon

change of reagent batch. They can even help laboratories

save time and money due to fewer lot crossovers.

• The availability of multi-analyte, multi-instrument controls

from Randox allow laboratories to replace multiple

instrument specific controls with a single control product.

Many instrument and reagent manufacturers provide dedicated

quality controls for use with their own reagents and analysers.

These controls are not as effective as third party controls and

often mask a multitude of weaknesses.

• In some cases the same raw materials are used to manufacture

both the controls and calibrators making the control less

sensitive to performance changes.

• Laboratories using an ‘in-kit’ control will receive a new lot

of QC with each new batch of reagent meaning they are

constantly changing lot number and do not have the benefit

of long term QC monitoring.

• Furthermore it is not uncommon for instrument and reagent

manufacturers to assign their QC using only a limited number

of results generated exclusively on their own instruments

using their own reagents and calibrators.

• This often results in perceived accuracy, unrealistic wide

ranges and batch to batch variability. The use of non third

party controls will ultimately lead to the release of incorrect

patient results.

Randox Third Party Controls

Instrument/Reagent Manufacturers ControlsVS

The Importance of Third Party Quality Controls

The following case studies highlight the importance

of third party controls and how they can be used to

help identify instrument, reagent and procedural errors

which if undetected could lead to the reporting of

incorrect patient results.

Detecting... instrument faults

1) The laboratory used the reagent manufacturer’s QC for all

Bilirubin testing. The assay appeared to be working well,

with QC results within range

2) They also ran Randox Acusera Assayed Chemistry

Premium Plus control and the results reported were

approximately 25% low to target

3) The laboratory contacted the Randox Technical Support

team, who provided them with some EQA samples

4) As suspected, results for these samples were 25% lower

than expected

5) Further investigations confirmed the low results were due

to an instrument fault

ConclusionRandox third party controls identified an instrument fault that

in-kit controls from the reagent manufacturer failed to detect.

The Importance of Third Party Controls in Helping to Detect Errors within the Laboratory

The Importance of Third Party Quality Controls

A real life laboratory situation

Quality Control

Detecting... shifts after changing reagent batch

Detecting... procedural errors

1) A laboratory using Randox Acusera Immunoassay Premium

Plus control reported their QC results for Thyroglobulin

were four times higher on their main analyser compared

to other systems

2) They ran the instrument manufacturer’s control alongside

the Acusera control but it did not show the same problem

3) After reviewing EQA data, the Randox Technical Support

team confirmed there was a significant difference in results

compared to other instruments

4) The customer contacted their instrument manufacturer, who

advised of a positive bias with several batches of reagent

Conclusion The Randox Immunoassay control detected a shift in results

that the instrument manufacturer’s control did not.

1) A laboratory using Randox Immunoassay Premium Plus

control reported their QC results for SHBG were much

higher than the target value provided

2) They also ran the reagent manufacturer’s control and

confirmed results were as expected

3) After reviewing the reagent kit insert, the Randox Technical

Support team noted that their instrument automatically

dilutes patient samples but not controls

4) The customer was unaware of this and had not been

diluting the controls. Good laboratory practice is to run

quality control materials the same way as a patient sample

Conclusion The Randox Immunoassay control detected a procedural

error that the reagent manufacturer’s control did not.

The Importance of Third Party Quality Controls

A real life laboratory situation A real life laboratory situation

Many regulatory bodies and standards from around the world highly recommend the use of true third party controls over

those of the instrument or reagent manufacturer.

The Clinical and Laboratory Standards Institute (CLSI) C24-A3, the Statistical Quality Control for Quantitative Measurement Procedures.

Regulatory Requirements Reinforce the Need to Use Third Party Quality Controls

The National Association of Testing Authorities, Australia (NATA) Supplemental Requirements for accreditation in the field of Medical testing.

NATA CLSI

The Importance of Third Party Quality Controls

“Controls independent of those produced by the manufacturer of the test or analyser should be used.”

“…quality control materials should be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of the measurement procedure’s performance in its entirety, including the procedure for calibration of the measurement.”

Quality Control

The Quality Council of India (QCI) Essential Standards for Registration of Medical Testing Laboratories in India, 3.5.2 Quality Assurance.

The Laboratory Accreditation Scheme of Malaysia (5.6.1 Quality Control).

“Medical laboratories shall perform internal quality control. Use of third party human matrix quality control is recommended for all analytes.”

“The use of controls independent from those produced by the manufacturer of the test or analyser is preferable.”

QCI LASM

The Importance of Third Party Quality Controls

Accurate target values Randox controls have the most accurately assigned target values

and ranges on the market. This is made possible through access

to a unique database of over 20,000 laboratory participants.

Unrivalled stability

Randox lyophilised controls have a shelf life of up to four years

enabling long term QC monitoring. The extended working

stability of Acusera controls means they will meet and often

exceed the stability claims quoted.

Convenient and easy-to-use

Many Randox controls are available in liquid format, eliminating

variability due to reconstitution errors.

Consolidation

With Randox multi-analyte QC, you can dramatically reduce

the number of controls used in your laboratory and save

money by replacing multiple instrument specific controls with a

single multi-analyser product.

Highest quality material The Randox range of lyophilised controls contain no added

preservatives or stabilisers which can cause interference

problems. In addition to this, all controls for use with antibody

based tests are made from 100% human serum providing a

matrix similar to the patient sample.

Quality Controls available

• Chemistry• Immunoassay• Immunology/Proteins• Cardiac

• Lipids• Diabetes• Urine Chemistry• Urinalysis

• Toxicology• TDM• Tumour Markers• Maternal Screening

• Coagulation• Blood Gas• Speciality/Research• Antioxidants

Information correct at time of print. Randox Laboratories Limited is a company registered within Northern Ireland with company number N.I. 15738. VAT Registered Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local Randox representative for information.

Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United KingdomT +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E marketing@randox.com I www.randox.com

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Randox is your Trusted Third Party QC Supplier

The Acusera range of true third party controls is extensive covering over 350 routine and esoteric parameters. All controls are

designed to help reduce the potential for bias by accurately and reliably identifying performance issues and potential weaknesses

with a test system or reagent.

Acusera 24•7 Live Online is a web based interlaboratory data management and peer group reporting package designed to compliment and support the Acusera range of control sera. Acusera 24•7 peer group data is uniquely updated every 24 hours providing users with the most up to date information.

RIQAS - The world’s largest global EQA scheme

• Blood Gas• Cardiac• Coagulation• Clinical Chemistry• Glycated Haemoglobin• Haematology

• Human Urine• Immunoassay• Immunoassay Speciality 1• Immunoassay Speciality 2• Lipids• Liquid Cardiac

• Maternal Screening• Serology (EBV)• Serology (HIV-Hepatitis)• Serology (Syphilis)• Serology (ToRCH)• Specific Proteins

• Therapeutic Drugs• Urinalysis• Urine Toxicology

(HbA1c)