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. • 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 W long term QC monitoring and the detection of shifts upon change of reagent batch •  hey can even help laboratories save time and money due T to fewer lot crossovers •  he availability of multi-analyte, multi-instrument controls T from Randox allows laboratories to replace multiple •  some cases the same raw materials are even used to In manufacture the controls and calibrators making the control less sensitive to performance changes •  aboratories using an ‘in-kit’ control will receive a new lot L 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 F 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 T 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