Post on 07-May-2015
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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
LT32
4 SE
P13
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)