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AOAC® 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, AOAC Official MethodsSM of Analysis and harmonized programs.

Service
Steps


Step 1: Application Process

Method Developer Submits:
  • Consulting application and remittance
  • Method Claims and Intended Use
  • Method applicability statement
    • Target analyte(s) and 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

  • Minimum of one (1) AOAC volunteer Material Expert reviews and approve protocols
    (Protocols for harmonized programs may require additional expertise for review and approval.) 

Step 4: Approved Testing Protocols

Validation outlines that include:
  • Testing protocol for single laboratory validation (SLV) study (method developer responsibility)
  • Testing protocol for independent laboratory study (AOAC Research Institute 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, US Food and Drug Administration – Center for Veterinary Medicine, MicroVal, GIPSA and AFNOR. 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*
  • $1,000.00 USD in addition per method for harmonized protocol with PTM program (e.g., PTM-OMA, etc…)
To access the form, please click Consulting Application or visit the AOAC website, click on Research Institute -> Method Submissions tab.

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