Division 2.3.5.4 Performance criteria for the determination of an analyte by an LC-immunogram
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A LC immunogram is not suitable on its own for use as a confirmatory method.
Relevant criteria for LC methods have to be fulfilled.
The pre-defined quality control parameters, e.g. non-specific binding, the relative binding of the control samples, the absorbance value of the blank have to be within the limits obtained during validation of the assay.
The immunogram has to be constructed of at least five fractions.
Each fraction shall be less than half of the peak width.
The fraction with the maximum content of the analyte has to be the same for the suspect sample, the non-compliant control sample and the standard.