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Is successful performance on semi-annual proficiency testing challenges sufficient to fulfill the requirement for ongoing validation?

April 26, 2017challenges fulfill ongoing PERFORMANCE proficiency requirement semi-annual successful sufficient Testing

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Is successful performance on semi-annual proficiency testing challenges sufficient to fulfill the requirement for ongoing validation?

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Yes, provided that there have been no significant changes in test methodology (e.g., antibody clone, method of antigen retrieval, detection system used). The assay must be re-validated whenever there is any change to test methods.