Importance of Using Third Party Controls
Importance of using third party controls
The importance of using third party controls cannot be overlooked. Using these controls can help to identify instrument, reagent and procedural errors which, if undetected could lead to the reporting of incorrect patient results!
What is a third party control?
ISO 15189:2012 states “the use of third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.” True third party controls are not optimised for use with a specific reagent or test system and therefore are renowned for delivering unbiased performance assessment with any instrument/method. The manufacturers of third party controls will usually assign values based on data collected from thousands of independent reference labs – thus ensuring the availability of statistically valid data for a wide range of platforms. Due to their independent nature and objectively assigned values you can be sure that third party controls will provide unbiased error detection across multiples platforms and methods.
First party control
Conversely, first party controls are analyser dependent controls that are supplied by the instrument/reagent manufacturer and are optimised specifically for use with the manufacturers test system and therefore will often mask weaknesses which could lead to the release of incorrect patient test results. These dependent controls are considered to lead to perceived accuracy and a biased assessment of performance.
Acusera third party controls
The Randox Acusera range of multi-analyte controls are true third party. Our controls have been designed to deliver an independent, unbiased assessment of performance with instrument or method. Our unique value assignment process employs thousands of independent laboratories ensuring statistically valid targets are available for most laboratory instruments. The availability of multi-analyte, multi-instrument controls with a shelf life of up to 4 years not only ensures continuity of lot supply but will significantly reduce costs and preparation time by reducing the need for multiple instrument specific controls.
Case Study 1
A laboratory running Acusera Immunoassay Premium Plus Control reported their QC results for Thyroglobulin were four times higher on the their main analyser compared to other systems.
They ran the instrument manufacturer’s control alongside the Acusera control but it did not show the same problem.
After reviewing EQA data, the Randox Technical Services 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.
In summary, the Randox Immunoassay Control detected a shift in results that the instrument dedicated control did not.
Case Study 2
A laboratory noticed an increase in native patient sample result recovery of around 15-20%. The lab were running their Gentamicin reagent along with a TDM calibrator. Over recovery was also noted for EQA samples however, the issue had not been detected with their current control set.
The laboratory got in touch with Randox about the use of our controls and if they would experience the same problems with our controls as they are with their current provider. We assured the laboratory that our controls were true third party and the unique 100% human serum matrix would provide a sample as close as possible to that of the patient.
The laboratory decided to test a sample of Acusera TDM control and were delighted with the results. They purchased some of our therapeutic drug controls and have yet to experience any increase in the result recovery of patient samples highlighting the need to use true third party controls.
This case study once again highlights how important running true third party controls is to a laboratory. It can be the difference between them reporting accurate and reliable patient test results and reporting incorrect results that could lead to a misdiagnosis which could be fatal to the patient on the receiving end.