Using Third Party Quality Controls to Improve Laboratory Performance

By Steven Jordan, Global Business Manager, Randox QC

Anyone working in a laboratory will understand the importance of quality control. QC is the process used to detect errors in order to ensure reliability and accuracy of patient test results. Without QC, laboratory errors could go unnoticed, potentially resulting in misdiagnosis and inappropriate or delayed treatment, all of which could be life-threatening to the patient.

When running internal QC, laboratories need to have confidence in the accuracy of the results produced. Only by using third party quality controls can they truly be assured of this. So what is the difference between a third party control and a control from an instrument or reagent manufacturer, and why should laboratories be using third party 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 it will better 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. Optimized for use with these specific assays or systems, these controls often mask weaknesses and therefore are increasingly considered less effective compared to third party controls.

This is a fact that is recognised by regulatory bodies and standards around the world, and this is corroborated in ISO15189. The Clinical and Laboratory Standards Institute (CLSI) sums it up nicely in the following statement:
“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.”

Third Party Controls

• True third party controls are manufactured independently meaning they give totally unbiased results.
• The leading third party control manufacturers assign target values using data from thousands of independent laboratories - genuinely independent, multi-method, and multi-analyzer data. The target values are, as a result, more accurate and reliable.
• Some third party controls offer extended shelf life of up to four years. This enables long term QC monitoring and the detection of shifts upon change of reagent batch. This can help laboratories save time and money due to fewer lot crossovers.
  

Instrument/Reagent Manufacturers Controls

• Some manufacturers use the same raw material to make both controls and calibrators, making the controls less sensitive to performance changes.
• It is not uncommon for instrument/reagent manufacturers to assign their QC values using only a limited number of results generated on their own instruments, using their own reagents and calibrators. This can result in perceived accuracy, unrealistic wide ranges and batch to batch variability.
• Laboratories using an ‘in-kit’ control will receive a new lot of QC with each new batch of reagents meaning they are constantly changing lot number and do not have the benefit of long term QC monitoring.
  

To read the real life laboratory case studies which highlight the importance of third party controls, please click here to download the full pdf article.

For more information on the benefits of third party controls please click on the 'request information' tab below or follow the company website link.