Field validation as a means for continual monitoring of approved test kit’s fitness for purpose in the commercial market

Abstract

Testing accuracy of a chemical contaminant requires use of a testing platform that conforms to validation criteria outlined in quality literature and standards. This study explores the application of commercial field data measured by qualified analysts using a United States Department of Agriculture – Federal Grain Inspection Service approved kit for measuring fumonisin in maize to augment method validation procedures. Analysts from seven grain testing facilities were qualified in official USDA sampling, sample preparation, and testing methodology using the Charm LF-FUMQ-WETS5. A duplicate sample was tested in the Office of the Texas State Chemist (OTSC) laboratory using UPLC-MS-MS. Data were subject to four statistical techniques using continuous and categorical methodology. This approach enabled researchers to explore if a single test or multiple comparisons were best suited to assess a field kit’s fitness for purpose across facility, toxin level, and year. The study concluded that a paired t-test and correlation analysis provided a quick and meaningful evaluation of kit performance. The correct placement of samples within the correct bin (violative versus non-violative) aligns well with market forces and regulatory compliance. The results of this study also provide a useful tool to assess all field kits’ performance at the beginning of the harvest season and subsequent years. The combination of statistical techniques presented in this research is an important tool in assessing mycotoxin field test kits fitness for purpose and represents a key step in a continuous improvement-quality systems process meant to protect the feed and food supply.

Keywords

• Fumonisin
• Test kits
• Toxicology
• Mycotoxins
• Risk management
• Regulation