Evaluating the Curve and QCs

The acceptance criteria used to accept or reject the run based on the curve and QCs are estabhshed during method validation (Section 10.3.3d) and must be documented in the method or appropriate laboratory SOP. As previously discussed, the targeted acceptance criteria to be used for 

In some instances during sample analysis, if the LLOQ calibrator fails the data can be reported with a raised LLOQ (perform the regression with the next highest standard as the revised LLOQ). Samples with concentrations below that of the raised LLOQ must then be re-assayed in another run if sufficient sample volume remains. 

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