# Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (notified under document number C(2002) 3044) (Text with EEA relevance) (2002/657/EC), Division 2.3.5.4: Performance criteria for the determination of an analyte by an LC-immunogram

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eudn/2002/657/annex/chapter/2.3/division/2.3.5.4 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-657/annex/chapter-2.3/division-2.3.5.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.