4.4.1 All validations in one test

The accuracy, recovery, linearity, reproducibility and LLOQ can be combined in one test.

If available, use an primal standard as sample and determine the linearity, reproducibility and recovery.

Perform the test together with a large series of blanks. For example, dilute std2 and std3 so that a sample with low and high concentration is formed and the other std4 as a medium sample.

Possible edge effects can be determined with std5 and std6. Have multiple people perform the test at least 5 times on different days.

This prevents a too good inter-assay VC from being established that cannot be matched in practice.

A control sample is unnecessary in this test design.