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For Clinical Labs: Avoid False-Positives and Negatives by Being a Control Freak

Posted by Eric Morreale, PhD on Nov 26, 2019 12:00:00 AM

static.scientificamerican.comblogscachefile5EE1BB90-E73C-4C3A-B5F056B02A78F7AFDo you consider yourself a control freak?

And by control, we mean quality control - the procedures and materials implemented to ensure test accuracy and precision. Most importantly, having the proper controls in place provides confidence in the accuracy of your tests and the reported results, reducing the risk of generating false-positives or false-negatives. A strong quality program has the added benefits of reducing both the amount of valuable staff time expended on troubleshooting, as well as costly instrument and assay downtime.

Gain More Control Within Your Lab Operations

In a clinical lab, quality control (QC) involves -- among many other things -- running known positive and negative samples (controls) on an assay to confirm performance. 

There are a number of factors that could cause an assay to fail: operator error, degrading reagents, faulty equipment. But if you have a sample with known characteristics, you can proactively identify potential issues. Where many quality control programs fall short, however, is in the strength of their control samples.

A common weakness is that many clinical labs rely on the controls provided in manufacturers’ assay kits. One significant problem with these manufacturer-provided controls is that they are typically strongly positive samples. But simply because an assay can detect a strong-positive, doesn’t mean it will also pick up lower concentrations of the target analyte that may be found in actual patient samples, especially near the clinically relevant assay cutoff. Furthermore, in-kit controls often mimic the calibrators, and do not offer a true long-term quality assessment of the assay across reagent lots.

Highly-characterized, patient-like external reference materials - manufactured independent of the IVD assay kit components and targeted near the test’s clinical cutoff - will challenge your assays more rigorously than standard internal kit controls.

Best-in-class QC means running both internal and external controls daily. Doing so will help you identify problems with your assays and procedures earlier. It will limit downtime for both equipment and staff, and most of all, will reduce the likelihood of sending erroneous results to clinicians.

What to Look for In Third-Party Controls

SeraCare’s portfolio of ACCURUN molecular and serology controls and reference materials are excellent examples of independent controls that will help you verify the accuracy of your assays and testing procedures. They:

  • Mimic true patient samples, enabling you to evaluate the entire testing workflow from extraction to detection, as a true full-process control should.
  • Feature weak reactivity, allowing your lab to better evaluate variability near the clinically relevant assay cut-off.
  • Are reliable, stable, and consistent. No more worries trying to identify a dependable source of high-quality reference materials.
  • Are ready to use. ACCURUN products require no preparation before use, and offer multiple configurations to choose from.

Avoiding false results in your clinical lab is all about gaining control by using the right controls. Learn more about improving the accuracy and efficiency of your lab in our free eBook for lab personnel, “Best Practices for Clinical Labs: Strategies for Implementing a Best-in-Class Quality Control System.”


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Topics: M&S