The Importance of Third Party Controls - LT324USA MAR 2014 | Page 3
The Importance of Third Party Quality Controls
Randox Third
Party Controls
Instrument/Reagent
VS Manufacturer’s Controls
Third Party is the term used to describe a control that has
not been designed or optimized 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.
Many instrument and reagent manufacturers provide dedicated
quality controls for use with their own reagents and analyzers.
These controls are not as effective as third party controls and
often mask a multitude of weaknesses.
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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 analyzers. Furthermore thousands of independent
laboratories are used during the value assignment process
with target values compared to reference methods to
ensure accuracy and reliability.
• ith a shelf life of up to four years Randox controls enable
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long term QC monitoring and the detection of shifts upon
change of reagent batch
• hey can even help laboratories save time and money due
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to fewer lot crossovers
• he availability of multi-analyte, multi-instrument controls
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from Randox allows laboratories to replace multiple
• some cases the same raw materials are even used to
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manufacture the controls and calibrators making the control
less sensitive to performance changes
• aboratories using an ‘in-kit’ control will receive a new lot
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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
• urthermore, it is not uncommon for instrument and reagent
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manufacturers to assign their QC using only a limited number
of results generated exclusively on their own instruments
using their own reagents and calibrators
• his often results in perceived accuracy, unrealistic wide
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ranges and batch to batch variability. The use of non third
party controls will ultimately lead to the release of incorrect
patient results
instrument specific controls with a single control product