评估 GENE-UP®沙门氏菌检测方法在广泛的食品和选择环境表面检测沙门氏菌属的能力：协作研究，2020.02 年首次行动。

Evaluation of the GENE-UP®Salmonella Method for the Detection of Salmonella Species in a Broad Range of Foods and Select Environmental Surfaces: Collaborative Study, First Action 2020.02.

机构信息

bioMérieux, Inc, 595 Anglum Road, Hazelwood, MO 63042, USA.

AOAC INTERNATIONAL, 2275 Research Blvd #300, Rockville, MD 20850, USA.

出版信息

J AOAC Int. 2021 Aug 20;104(4):1084-1097. doi: 10.1093/jaoacint/qsab005.

DOI:10.1093/jaoacint/qsab005

PMID:33774653

Abstract

BACKGROUND

The GENE-UP®Salmonella assay (Performance Tested MethodSM [PTM] 121802) is a PCR detection method that utilizes fluorescence resonance energy transfer (FRET) hybridization probes for the rapid detection of Salmonella species in foods and on environmental surfaces.

OBJECTIVE

The purpose of this validation was to evaluate the method's interlaboratory performance for submission to AOAC INTERNATIONAL for adoption as First Action Official Method of AnalysisSM.

METHOD

The GENE-UP method was evaluated in a multi-laboratory study using unpaired test portions for one food matrix, raw ground beef (80% lean). The candidate method was compared to the US Department of Agriculture (USDA), Food Safety Inspection Service, Microbiology Laboratory Guidebook (MLG) 4.10 reference method. An alternative confirmation procedure, using ASAP™ and CHROMID®Salmonella chromogenic agars, was included in the validation study. Fifteen collaborators from 14 laboratories participated. Three levels of contamination were evaluated: a non-inoculated control level (0 CFU/test portion), a low contamination level (∼0.7 CFU/test portion), and a high contamination level (∼2 CFU/test portion). Data were analyzed using the probability of detection (POD) statistical model.

RESULTS

The dLPODC values with 95% confidence interval for the GENE-UP Salmonella method, with either alternative or traditional confirmation, were: 0.00 (-0.03, 0.03), -0.02 (-0.15, 0.12), and 0.02 (-0.03, 0.09) for the non-inoculated, low, and high contamination levels respectively.

CONCLUSIONS

The dLPODC results demonstrate no difference in performance between the candidate method and reference method for the matrix evaluated.

HIGHLIGHTS

The GENE-UP Salmonella method, with ASAP and CHROMID Salmonella, provides industry with a simplified, rapid, and accurate workflow for the detection of Salmonella in a broad range of foods and select environmental surfaces.

摘要

背景

GENE-UP®沙门氏菌检测试剂盒（性能测试方法 [PTM] 121802）是一种 PCR 检测方法，它利用荧光共振能量转移（FRET）杂交探针，用于快速检测食品和环境表面中的沙门氏菌。

目的

本验证旨在评估该方法的实验室间性能，以便向 AOAC INTERNATIONAL 提交作为第一行动官方分析方法 [SM]。

方法

在一项多实验室研究中，使用未配对的测试样本评估 GENE-UP 方法，用于一种食品基质，即 80%瘦肉的生碎牛肉。候选方法与美国农业部（USDA）食品安全检验局微生物实验室指南（MLG）4.10 参考方法进行比较。在验证研究中还包括了一种替代确认程序，使用 ASAPTM 和 CHROMID®沙门氏菌显色琼脂。来自 14 个实验室的 15 名合作者参与了该研究。评估了三个污染水平：未接种对照水平（0 CFU/测试样本）、低污染水平（约 0.7 CFU/测试样本）和高污染水平（约 2 CFU/测试样本）。使用概率检测（POD）统计模型对数据进行分析。