The Performance Tested Methods program has five main elements: 1) Data Submissions with Application; 2) Expert Reviews/General Referee; 3) Independent Testing Laboratory; 4) The Performance Tested Methods Certification Mark; and 5) Annual Reviews.

Data Submission
Test kit manufacturers seeking Performance Tested Methods status are required to produce and submit data to support product performance claims. The AOAC RI has created guidelines known as "Data Submission Requirements" that prescribe the types of data required to support performance claims. Data required by the AOAC RI guidelines are submitted in a method validation report.

In some cases, government agencies or other organizations may cooperate with the AOAC RI. In these cases a specific data submission requirement may be developed in cooperation with a cooperating organization. Successful validation of a test kit using these specific data submission requirements will result in the additional recognition of the Performance Tested Methods status by the cooperating organization. This is the case for test kits that detect antibiotic residues in milk. The AOAC RI has developed a set of protocols in cooperation with the US Food and Drug Administration. The US Food and Drug Administration recognizes the Performance Tested Methods status for test kits that are successfully validated using these protocols.

Expert Reviewers / General Referees
The AOAC RI recruits independent experts (known as "Expert Reviewers") and selects a General Referee to review the performance data of test kits. Expert Reviewers are routinely recruited from the AOAC network of method volunteers, but the program is not limited to selecting AOAC members or method volunteers as Expert Reviewers. The Expert Reviewers and the General Referee evaluates the data submitted by manufacturers and the data generated by the independent testing laboratories. Expert Reviewers and a General Referee are the backbone of the program, providing the AOAC RI with much expertise and making recommendations to approve or deny Performance Tested Methods status of test kits. In addition, in the case of microbiology methods, the General Referee ensures that the final method validation report meets Pre-Collaborative study requirements.

Independent Testing Laboratory
After data submissions for a test kit have been reviewed and found by the Expert Reviewers and General Referee to support the product performance claims, the test kit performance is verified by testing at an Independent Testing Laboratory. These evaluation are conducted using protocols developed by the Expert Reviewers and General Referee. The data generated by the Independent Testing Lab is sent to the Expert Reviewers and General Referee, who evaluate the data to determine whether the independent laboratory data corroborates the data submitted by the manufacturer. If the two sets of data are found to corroborate each other, and support the product performance claims, then the Expert Reviewers and General Referee will recommend Performance Tested Methods status for the test kit.

Certification Mark
If the Expert Reviewers and General Referee find that all of the data supports the product performance claims, then test kits are granted Performance Tested Methods status and are licensed to use the Performance Tested Methods certification mark on their packaging and in their advertisement. The Performance Tested Methods certification mark is recognized by a variety of organizations and government agencies. In all cases, the Performance Tested Methods status is granted for a period of one year. Certification of test kits must be renewed annually.

Annual Reviews
Companies with approved test kits must submit technical inserts and labels for review every year. They must also sign the Certification Mark License Agreement and certify that there have been no changes made in the test kit, the technical insert, or the quality control and quality control procedures.