Method Verification Workshop
Method verification requires objective evidence that a laboratory can adequately operate a standard method and meet the performance parameters specified in the test method with the matrices to which the method is being applied. Most often, the critical requirements are trueness and precision which are reflected in the measurement uncertainty. The objective evidence is the trueness and precision obtained from actual laboratory data. The Technical Division for Laboratory Management (TDLM) has drafted a guide on "How to Meet ISO 17025 Requirements for Method Verification." TDLM hosted a symposium at the 2007 AOAC Annual Meeting on method verification at which the guide was introduced.
Attendees at the 2007 symposia of TDLM on Method Verification requested that TDLM conduct a workshop on Method Verification in 2008. AOAC provided a unique opportunity for interaction between attendees and presenters by offering a workshop rather than a symposium. Participants and presenters worked through examples. The lively discussion generated a request to post the presentations and the examples on the AOAC web site. The examples covered chemistry methods that quantified both high and low concentrations as well as methods determining if an analyte is present above or below a specified, low concentration (often called a Limit Test). In this latter type of method, the specified concentration is close to the LOQ. The examples covered not only chemistry, but also microbiology. AOAC has posted the chemistry presentations and examples to provide guidance on the possible approaches to method verification.
Presentations
Method Verification Part II - TDLM Workshop - John Szpylka, Ph.D.
Technical Manager
Medallion Laboratories
Verification of Performance
Characteristics of Standardised
Methods
- Franz Ulberth
Method Verification - The How -
M.L. Jane Weitzel
ALACC Chair
Examples
Example 1: Determination of Total Fat in Cereal
Example 2: Determination of Low-Level Glucose in Sugar
Example 3: Determination of Vitamin D3 in Food
Example 4: Detection of Salmonella in Cloves (AOAC 967.26)
Limit of Detection Program for Qualitative Microbiology Methods
Reference: EP 12-A2, User Protocol for Evaluation of Qualitative Test Performance: Approved Guideline - Second Edition, CSLI
Determination of Aflatoxin B1 in Peanut Butter
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