In this interview with Westgard, NRL scientists Dr. Wayne Dimech and Joe Vincini explain why traditional QC methods, like Westgard Rules and Six Sigma, don’t work for serology. They discuss the need for non-Gaussian, tailored approaches to ensure reliable results and highlight key findings from their recent publications.

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Traditionally, laboratories set QC acceptance limits using as few as 15 data points and then calculate mean +/- 2 standard deviations to establish control limits.  Westgard rules are used to identify results that are “out of range”.  However, this method has been proven to be not fit for purpose and causes unnecessary work troubleshooting “false rejections”, resulting in extra cost and delays in patient testing.

As specialists in infectious disease quality control, NRL has developed and validated a more appropriate approach to monitoring infectious disease QC.  QConnect uses historical data submitted into our real-time QC software EDCNet, to calculate acceptance limits for each QC/Assay combination, using thousands of QC results.  In this way, participants can be confident that any QC results falling outside this range, truly represents an unexpected variation, which requires investigation.

NRL QConnect approach is the only scientifically validated way to monitor infectious disease testing QC results.

1. Highest quality control samples, using true human disease-state plasma, optimised for each test system
2. Data collection into the cloud-based EDCNet software
3. EQC test results, analysed against peer (EQC/Test Kit) test results, displayed in graphical and tabular forms
4. QConnect Limits, established using thousands of peer results, set upper and lower acceptance limits of EQC results, flagging when unacceptable results are detected.