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Consulting Service - Protocol Development


The Consulting Service offered by the AOAC Research Institute is an OPTIONAL service designed to develop and provide complete individualized validation outlines for method developers.  Validation outlines include all pertinent testing protocols, acceptance criteria, and reference materials or reference methods.


The service leverages the expertise and experience of AOAC technical consultants, expert AOAC volunteers and global subject matter experts to peer review and approve testing protocols for AOAC; thereby reducing and eliminating the guesswork and risk of potentially expensive re-testing.  The Consulting service allows method developers to quickly organize your study to collect the exact data needed to evaluate and validate a method.


Validation outlines are developed for AOAC Performance Tested MethodsSM and Official MethodsSM programs.  Harmonized outlines may also be developed.

For further information and reference, please see the AOAC Research Institute Consulting Services – E-Book.

Step 1:  Application Process


  • Method Developer Submits: 
    • Consulting application and remittance
    • Method Claims and Intended Use
    • Method applicability statement
      • Target analyte(s)
      • Matrixes 
    • Method instructions 
      • For rapid methods or test kits, please submit package insert or user instructions

Step 2:  Drafting Testing Protocols

  • AOAC RI Provides:
    • Technical expertise to draft the validation outline documents and facilitate review process 
    • AOAC Guidelines and overview of current technical requirements
    • Appropriate reference materials/methods (if applicable)
    • Specific validation testing protocols
    • Expert peer review and approval of testing protocols

Step 3: Expert Peer Review and Approval


AOAC Performance Tested MethodsSM

  • Minimum of AOAC volunteer expert(s) can review and approve protocols 


AOAC Official MethodsSM

  • Minimum of two (2) AOAC Expert Review Panel members
  • Statistical review, if applicable
  • Safety Review, if applicable
Protocols for harmonized programs may require additional expertise for review and approval.

Step 4:  Approved Testing Protocols


AOAC Performance Tested MethodsSM

  • Validation outlines that includes
    • Testing protocol for single laboratory validation study (method developer responsibility)
    • Testing protocol for independent laboratory study (AOAC Research Institute responsibility)

AOAC Official MethodsSM

  • Reproducibility evaluation protocol (method developer responsibility)
AOAC approved testing protocols are valid for one year from the date of approval.

Joint Program Protocol Development


Joint program protocol development or harmonized validation outlines can be developed to satisfy requirements of both programs.   A validation outline for a method to be submitted for PTM review can be designed and reviewed to satisfy the requirements for methods in the OMA program.  AOAC Research Institute has also developed joint protocols with US Food and Drug Administration – Center for Veterinary Medicine and MicroVal. Method developers planning to do a joint program method submission are REQUIRED to use the Consulting Service.

Fees


Consulting application fee:
  • $3,000.00 USD per kit for Non-Contributing Members
  • $2,000.00 USD per kit for Contributing Members*
*A $500 discount will be applied to the PTM application when consulting services are requested.

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