DRAFT AOAC SMPR 2014.XXX; Version 5; July 21, 2014
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Method Name: Screening Method for PDE5 Inhibitors
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Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics to be used
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during the evaluation of a method. The evaluation may be an on-site verification, a single-laboratory
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validation, or a multi-site collaborative study. SMPRs are written and adopted by AOAC Stakeholder
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Panels composed of representatives from the industry, regulatory organizations, contract laboratories,
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test kit manufacturers, and academic institutions. AOAC SMPRs are used by AOAC Expert Review Panels
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in their evaluation of validation study data for method being considered for
Performance Tested
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Methods
or AOAC
Official Methods of Analysis
, and can be used as acceptance criteria for verification at
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user laboratories.
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Approved by:
Stakeholder Panel on Dietary Supplements (SPDS)
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Final version date
:
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Effective date:
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Intended Use
: Routine surveillance of dietary ingredients and products by a trained technician.
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1.
Applicability
:
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Qualitative assay for PDE5 inhibitors in dietary ingredients and supplements.
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2.
Analytical Technique
:
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Any analytical technique(s) that detects the analytes of interest and meets the following method
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performance requirements is/are acceptable.
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3.
Definitions
:
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Dietary Ingredients
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A vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man
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to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent,
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extract, or combination of any of the above dietary ingredients.
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Dietary supplements
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A product intended for ingestion that contains a "dietary ingredient" intended to add further
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nutritional value to (supplement) the diet. Dietary supplements may be found in many forms such as
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tablets, capsules, softgels, gelcaps, liquids, or powders.
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Interference Control
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A control designed to confirm that a test matrix does not interfere with the assay's ability to detect
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target compounds.
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Probability of Detection (POD)
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The proportion of positive analytical outcomes for a qualitative method for a given matrix at a given
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analyte level or concentration.
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US FDA.
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Appendix H: Probability of Detection (POD) as a Statistical Model for the Validation of Qualitative Methods,
Official Methods of Analysis of AOAC INTERNATIONAL, 19
th
edition, 2012.
