AOAC’s Research Institute Performance Tested Consumables (PTC) Program

The AOAC Research Institute (AOAC RI) is a division of AOAC INTERNATIONAL that promotes and conducts activities to help develop, improve, and validate proprietary consumables.

Performance Tested Consumables (PTC) Overview

The Performance Tested Consumables (PTC) program enables laboratories to have confidence in the performance of consumables and provides data that can be used in the evaluation and risk analysis associated with purchasing quality-critical consumables. The PTC program provides a turnkey solution to evaluating consumables and giving third party credibility of consumables by providing a independent evaluation of the items against claims made by a manufacturer.

Purpose

Laboratory consumables can be critical to the successful performance of test methods in the laboratory, but laboratories have no industry-accepted criteria for acceptance of these items upon receipt. Consumables do not provide the result but contribute to the result or to the measurement uncertainty of a method. The purpose of the PTC program is to provide an expert-reviewed certification of these items that is reviewed regularly to give confidence in the items that they rely on so heavily for the successful performance of test methods. PTC certification helps laboratories comply with section 6.6 of the ISO/IEC 17025:2017 standard.

Manufacturers may hold ISO 9001 certification, but that addresses the manufacturing of the item, not the quality control and the ability to meet claim. ISO 9001 is an important element for consistency of operation but not performance of claims. The PTC program fills a noted gap in the industry by evaluating claims made on consumables.

Process

The PTC program process is: 

1. The manufacturer and an AOAC RI technical consultant prepare an outline for validation study protocols in the consulting phase. 
2. AOAC staff reviews the application.
3. The manufacturer completes its validation study.
4. AOAC RI helps to select an independent lab to complete the independent validation study.
5. AOAC RI facilitates expert peer review of the results of both validation studies. If approved, AOAC RI grants AOAC Performance Tested^SM certification, and the organization is licensed to use the certification mark.
6. The certification is reviewed for renewal the following year.

Product Types and Criteria

Table 1 shows examples of different types of consumables and likely claims that would be needed. Single or multiple claims may be made, and the list of claims is determined by the manufacturer at the time of application. It is possible for two manufacturers to have different claims as required by their business needs.

Table 1: Examples

For claims that have standards for testing, we utilize them as part of the evaluation process. For example, in the case of sampling devices that have a sterility claim, the USP methods for sterility are the reference.