For the purposes of assays with Internal Quality Control (IQC) readily available, analysis of MU is based on that IQC data assessed over an adequate period of time. Depending on the availability of the data and the nature of the individual assay, that period of time may vary.
Where IQC is not readily available, other methods by which to assess the assay performance are required. These may include but are not limited to:
- Competency assessment (and therefore a means of Inter Rater Reliability)
- Performance in External Quality Assurance (EQA – as an example of proficiency testing).
The method used will be defined on an individual assay basis, locally, and justification for which method is to be used is to be provided by the scientist performing the assessment. Examples of which methods are used for specific assays are provided in the Examples section. These are only suggested approaches that can be used.