Based on recent events, I’m restating that for a clinical assay, good quality control results do not imply good quality. Of course, good quality control results is a good thing and poor quality control results means that there are problems, but here are some examples where good quality control results don’t mean good quality.
- QC samples do not inform about patient sample interferences, which can cause large errors and result in patient harm. Such events could occur with perfect QC results.
- QC informs about biases that persist across time. For example if QC is performed twice per day, a bad calibration (where calibration lasts for a month) will likely be detected. But short term biases will likely be missed.
So if anyone claims, you can select your lab’s quality by running QC according to some scheme, it’s simply not true.