Food Research Institute

Şahiner, A. – Ateş, M.
Intra-laboratory validation of commercially available ELFA-based assay and PCR-based assay for detection of Listeria monocytogenes in food samples according to ISO 16140-2
Journal of Food and Nutrition Research, 62, 2023, No. 4, s. 297-304

Aslı Şahiner, Department of Biology, Basic and Industrial Microbiology Section, Faculty of Science, Ege University, Ankara Road, 292, 35100 Bornova, Izmir, Turkey. E-mail: asli.sahiner@ege.edu.tr

Original article
Received 4 March 2023; 1st revised 17 May 2023; 2nd revised 24 July 2023; accepted 26 July 2023; published online 3 September 2023

Summary: In this study, commercially available VIDAS system based on the enzyme linked fluorescent assay (ELFA; BioMérieux, Lyon, France) and the BAX system based on polymerase chain reaction (PCR; Hygiena, Camarillo, California, USA) were compared to the reference culture-based method (EN ISO 11290-1) to detect Listeria monocytogenes in food samples. The process was carried out in accordance with criteria for methods comparison established in EN ISO 16140-2 for validation of alternative microbiological methods. As a result of validation studies with food samples, sensitivity rates for samples in all food categories were determined as 97.2 % for the ELFA method and 97.9 % for the PCR method. Level of detection of the ELFA method per 25 g was determined to be 1.1–4.3 CFU and of the PCR method was determined to be 2.7–8.0 CFU. The method comparison study is a part of the validation process that takes place in analysis laboratories. Although the VIDAS System and BAX System have been used in food analysis laboratories for many years, this study is the first intralaboratory method validation study conducted in accordance with the latest version of ISO 16140-2 against a reference method.

Keywords: Listeria monocytogenes; rapid microbiological method; intra-laboratory validation; enzyme-linked flouorescent immunoassay; polymerase chain reaction

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