Validating chromatographic methods a practical guide

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The work flow in the present project consisted of writing draft SOPs for each parameter relevant to validation of a method for determination of an analyte concentration in a biofluid.Task members were then asked to review and revise the SOPs, whereafter they were evaluated in at least three multicenter studies.The intended use for such a method could be to use the outcome as a diagnostic marker and in this case some evidence should be in place showing that there is a disease-dependent change in the analyte concentration in a biological sample.

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Examples include making a clinical diagnosis, initiating and monitoring treatment, predicting prognosis or disease recurrence after treatment.For example, carryover should be investigated in a chromatography-based method while it is not applicable in an ELISA.The aim of the present work was to present straightforward step-by-step standard operating procedures (SOPs) for the validation of methods in which an analyte is determined in a biofluid matrix; the SOPs have been developed with the intention that they should be possible to follow without any advanced prior training.As a consensus agreement in the group, it was decided that a partial validation of a commercial assay should include all parameters except for robustness, which should have been covered by the manufacturer during method development.Even more limited partial validations may be eligible under other circumstances.

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