The Reviewed and Recognized SM (R2) validation program is the newest offering from the AOAC Research Institute.
Reviewed and Recognized SM (R2) Overview
The Reviewed and Recognized SM (R2) validation program from the AOAC Research Institute (AOAC RI) is designed to evaluate performance claims on “application notes”, or instructions for use that describe how an instrument or analytical equipment can be used to detect, quantify or identify specified analytes in matrices. Functionally, the R2 program will operate very similarly to the AOAC RI Performance Tested Methods (PTM) program.
The R2 program process is:
- The method developer and an AOAC RI technical consultant prepare a validation outline for validation study protocols in the consulting phase.
- AOAC staff reviews the application.
- The method developer completes its validation study.
- AOAC RI selects an independent lab to complete the independent validation study.
- AOAC RI facilitates expert peer review of the results of both validation studies. If approved, AOAC RI grants AOAC R2 certification, and the organization is licensed to use the certification mark.
- The certification is reviewed for renewal the following year.
Data Requirements for Reviewed and Recognized SM
- Data from method developer and one qualified independent laboratory required
- Selectivity and method performance for all claimed matrixes
- Equipment/component quality assurance
- Method transferability
- Customized processes available
Method Submission for Reviewed and Recognized SM
AOAC Expert Reviewers review validation manuscripts and application notes for R2 certification.
Successful methods described in application notes will receive a certification mark and certificate with a unique license number.
- Database of R2 certificates coming soon!
- Validation manuscripts published in the Journal of AOAC INTERNATIONAL
- Method modifications and extensions validated to keep pace with innovations
- Can be the first step of Official Methods of AnalysisSM process
Program Deadlines and Pricing
With program launch on October 1, 2021, AOAC RI will accept the first 10 applications in order to ensure adequate staff and technical consultant support for timely application review and processing. Additional applications to the program will be considered and accepted after processing of the initial group has been completed.
The AOAC RI is offering an introductory cost of $10,000 per application through March 31, 2022. Beginning April 1, 2022, application pricing will align with the PTM pricing schedule.
For all questions, contact Nora Marshall, Senior Manager, AOAC Research Institute, at [email protected].