Program Elements - Overview
The Performance Tested Methodssm program has five main elements:
Data Submission with Application
Expert Reviewers/General Referee
Independent Testing laboratory
The Performance Tested Methods sm Certification Mark
Test kit manufacturers seeking Performance Tested Methodsm 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 the cooperating organization. A successful validation of a method using these specific data submission requirements will result in the additional recognition of the Performance Tested Methodsmstatus by the cooperating organization. This is the case for methods 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 Methodsm status for methods that are successfully validated using these protocols.
Expert Reviewers/General Referee :
The AOAC-RI recruits independent experts (known as “Expert Reviewers”) and selects a General Referee to review the performance data of the method. 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 evaluate the data submitted by the manufacturers and the data generated by the independent testing laboratories. Expert Reviewers and the General Referee are the backbone of the program providing the AOAC-RI with a wealth of expertise and recommendations to approve or deny Performance Tested Methodsm status of a method. 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 the data submission for the method have been reviewed and found to support the product performance claims, by the Expert Reviewers and General Referee, the method performance is verified by an Independent Testing Laboratory. The evaluation is conducted using protocols developed by the Expert Reviewers and General Referee. The data generated by the Independent Testing Laboratory is sent to the Expert Reviewers and General Referee for evaluation 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 Methodsm status for the method.
Once the Expert Reviewers and General Referee conclude that the data supports the product performance claims, then the method will be granted Performance Tested Methodsm status. The manufacturer will be licensed to use the Performance Tested Methodsm certification mark on packaging and in product advertisements. The Performance Tested Methodsm license is granted for a period of one year and the certification must be renewed annually.
Annual Reviews :
Manufacturers with approved methods must submit technical inserts and labels for their annual renewals. They must inform AOAC-RI if there are any deviations from the originally certified method along with submitting the modified technical inserts, quality control and quality control procedures.