Commercial assay kits quality control

Quality control and acceptance criteria have also been topics of much debate. We will attempt to address the main points to be considered when using commercial assay kits here. 

Quality Control Acceptance Criteria Commercial assay kits that also have QC samples supplied will normally contain data on expected target value for each QC sample and usually also expected or acceptable ranges. The procedures used to produce these figures and reasoning behind them can vary widely between different manufacturers and so great caution is required, particularly with R D type kits. It is common to find that these ranges do not have any connection to the actual performance of the assay from a statistical standpoint, and also that they are usually much wider than one may want to accept (or achieve). 

Quality control Run quality control samples (commercial kit supplied or spiked sample matrix) as part of precision testing during validation. This data can be used to confirm and/or establish QC ranges that will be used to monitor the assay when used on toxicology studies Mean 2SD/3SD or 20% nominal (expected) values... 

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