Understanding the benefits of Third-Party IVD controls
In a laboratory Quality Control (QC) refers to the process of identifying analytical errors to ensure the accuracy and reliability of test results. QC testing is a basic requirement for any laboratory, however, the reliability of QC systems used in different laboratories can vary depending on the control materials that are used.
What are dependent/first-party controls?
Dependent controls refer to any control material that has been produced by the instrument or reagent manufacturer for use on a specific platform. Such controls are often manufactured from the same raw materials as the calibrator, making them less sensitive to subtle changes in performance.
As dependent controls are generally optimised for use with the manufacturer’s platform, these controls can mask weaknesses, and therefore, are increasingly considered less effective than independent controls.
What are independent/third party controls?
Independent or third party quality control materials have not been designed or optimised for use with any instrument, kit or method. This complete independence enables the quality control material to closely mirror the performance of patient samples, and in doing so, provides an unbiased, independent assessment of analytical performance across multiple platforms.
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.”
Typically, clinical lab managers are driven by two main objectives. The first is running a lab that consistently delivers accurate results so patients receive the most effective treatment in a timely manner. The second responsibility is to provide this service in the most cost-effective way possible. This often means managing resources to stay within budgets and avoiding unnecessary spending. A common perception is that increased quality results in higher costs.
What if increased investment in QC measures resulted in decreased laboratory costs?
The above statement may sound counterintuitive as third party controls can seem like just another added expense to the lab but the cost of reporting inaccurate results can be much greater. Every time an assay fails in a clinical lab it can cause the cost of a single test to increase significantly due to:
- Repeat testing – the test may have to be repeated a number of times to deliver a reportable result.
- Disruption to testing – equipment may have to be shutdown to determine the cause of the problem, reducing the number of samples the lab can process.
Furthermore, increased cost and disruption is not be the only way a lab can be affected by reporting inaccurate results. If a lab releases inaccurate results this can lead to misdiagnosis which in certain cases can have serious implications for a patient. As a result this can cause a laboratories reputation to be severely damaged.
Third party controls have grown in popularity with their benefits being widely accepted and recommended by regulatory bodies in the field of quality control. More and more labs are using them as part of their daily QC routine due the the increased confidence it instils in your results.
Our partner, Microbiologics, supply an extensive portfolio of independent third party controls in convenient ready to use kits. From the KWIK-STIK™ range for growing reference cultures for QC testing to Helix Elite™ Molecular Standards they’ve got you covered!
Benefits of using Microbiologics third party controls
- IVD controls and panels provide assurance in your results.
- Multiple platform compatibility.
- Third-party controls deliver an unbiased and independent assessment of assay performance.
- Convenient test-ready formats that save you time and money.
- Lyophilization allows for easy storage (no freezing required) and ensures stability.
As an IVD third-party control manufacturer, Microbiologics provides an unbiased independent assessment to your laboratory. Every laboratory has its own preferences, which is why Microbiologics provide options suiting everyone’s needs: assayed/unassayed, single target/ multi-analyte controls, and pellet/swab format. Comparing the extreme cost of inaccurate results and assay downtime with the minimal cost of third-party controls, you’ll discover that Microbiologics controls are an investment that will pay off many times over.
Get in touch with our product specialist below for more information about Microbiologics control or browse the range here.
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