Scientific Publications by FDA Staff

J AOAC Int 2016 Mar-Apr;99(2):407-16

Validation of the Applied Biosystems 7500 Fast Instrument for detection of Listeria species with the SureTect Listeria species PCR assay.

Cloke J, Arizanova J, Crabtree D, Simpson H, Evans K, Vaahtoranta L, Palomaki JP, Artimo P, Huang F, Liikanen M, Koskela S, Chen Y

The Thermo Scientific SureTect Listeria species Real-Time PCR Assay was certified during 2013 by the AOAC Research Institute (RI) Performance Tested Methods(SM) program as a rapid method for the detection of Listeria species from a wide range of food matrixes and surface samples. A method modification study was conducted in 2015 to extend the matrix claims of the product to a wider range of food matrixes. This report details the method modification study undertaken to extend the use of this PCR kit to the Applied Biosystems 7500 Fast PCR Instrument and Applied Biosystems RapidFinder Express 2.0 software allowing use of the assay on a 96-well format PCR cycler in addition to the current workflow, using the 24-well Thermo Scientific PikoReal PCR Instrument and Thermo Scientific SureTect software. The method modification study presented in this report was assessed by the AOAC-RI as being a level 2 method modification study, necessitating a method developer study on a representative range of food matrixes covering raw ground turkey, 2% fat pasteurized milk, and bagged lettuce as well as stainless steel surface samples. All testing was conducted in comparison to the reference method detailed in International Organization for Standardization (ISO) 6579:2002. No significant difference by probability of detection statistical analysis was found between the SureTect Listeria species PCR Assay or the ISO reference method methods for any of the three food matrixes and the surface samples analyzed during the study.