评价 GENE-UP® 李斯特菌属方法在多种食品和选择环境表面检测李斯特菌属的应用：协作研究，2019.10 年首次行动。

Evaluation of the GENE-UP® Listeria spp. Method for the Detection of Listeria Species in a Variety of Foods and Select Environmental Surfaces: Collaborative Study, First Action 2019.10.

机构信息

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

bioMérieux, Inc., Chemin de l'Orme, 69280 Marcy L'Etoile, France.

出版信息

J AOAC Int. 2021 Mar 5;104(1):192-203. doi: 10.1093/jaoacint/qsaa103.

DOI:10.1093/jaoacint/qsaa103

PMID:33452805

Abstract

BACKGROUND

The GENE-UP® Listeria spp. 2 (LIS 2) assay (Performance Tested MethodSM 121803) is a real-time PCR molecular detection method for the rapid detection of Listeria species (Listeria monocytogenes, L. innocua, L. ivanovii, L. seeligeri, and L. welshimeri) in a variety of foods and environmental surfaces.

OBJECTIVE

The purpose of this validation was to evaluate the method's interlaboratory performance and submit the results to AOAC INTERNATIONAL for adoption as First Action Official MethodSM for the detection of Listeria species in a variety of foods and select environmental surfaces.

METHOD

The GENE-UP method was evaluated in a multi-laboratory study as part of the AFNOR NF VALIDATION certification process using unpaired test portions for one food matrix, full-cream goat milk cottage cheese (8.4% fat). The candidate method was compared to the ISO 11290-1/Amd.1 reference method. Sixteen participants from 15 laboratories throughout the European Union participated. Three levels of contamination were evaluated: a non-inoculated control level (0 CFU/test portion), a low contamination level (∼2 CFU/test portion), and a high contamination level (∼10 CFU/test portion). Data from that study were analyzed according to the probability of detection (POD) statistical model.

RESULTS

The dLPODC values with 95% confidence intervals between the candidate and reference method results were -0.02 (-0.07, 0.03), -0.08 (-0.31, 0.16), and 0.00 (-0.03, 0.03) 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

Data from a singular collaborative study was used to achieve adoption as an AOAC First Action Official Method for the detection of Listeria species in a variety of foods and select environmental surfaces.

摘要

背景

GENE-UP®李斯特菌属 2 （LIS 2）检测法（经性能验证的方法 121803）是一种实时 PCR 分子检测方法，用于快速检测多种食品和环境表面中的李斯特菌属（单核细胞增生李斯特菌、无害李斯特菌、伊氏李斯特菌、希氏李斯特菌和威尔斯李斯特菌）。

目的

本验证的目的是评估该方法的实验室间性能，并将结果提交给 AOAC INTERNATIONAL 采用，作为用于检测多种食品和选择环境表面中李斯特菌属的第一行动官方方法 SM。

方法

在作为 AFNOR NF VALIDATION 认证过程的一部分的多实验室研究中，使用单份测试部分评估 GENE-UP 方法，用于一种食品基质——全脂山羊奶干酪（8.4%脂肪）。候选方法与 ISO 11290-1/Amd.1 参考方法进行了比较。来自欧盟 15 个实验室的 16 名参与者参加了该研究。评估了三个污染水平：非接种对照水平（0 CFU/测试部分）、低污染水平（约 2 CFU/测试部分）和高污染水平（约 10 CFU/测试部分）。根据检测概率（POD）统计模型对该研究的数据进行了分析。