评价 GENE-UP® 李斯特氏菌检测方法用于检测多种食品和特定环境表面中李斯特氏菌：协作研究，2019.11 年第一行动。

Evaluation of the GENE-UP® Listeria monocytogenes Method for the Detection of Listeria monocytogenes in a Variety of Foods and Select Environmental Surfaces: Collaborative Study, First Action 2019.11.

机构信息

bioMérieux, Inc., 595 Anglum Road, 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):180-191. doi: 10.1093/jaoacint/qsaa079.

DOI:10.1093/jaoacint/qsaa079

PMID:33609031

Abstract

BACKGROUND

The GENE-UP® Listeria monocytogenes 2 (LMO 2) assay (Performance Tested MethodSM 121804) uses real-time PCR technology and a proprietary detection platform, the GENE-UP Thermocycler, to detect Listeria monocytogenes 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 result to AOAC INTERNATIONAL for adoption as First Action Official MethodSM for the detection of Listeria monocytogenes 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.1:2004 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 inoculum level (∼2 CFU/test portion), and a high inoculum level (∼10 CFU/test portion). Data from the study were analyzed according to the Probability of Detection (POD) statistical model as presented in the AOAC validation guidelines.

RESULTS

The dLPODC values with 95% confidence interval for each comparison 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

The GENE-UP LMO method demonstrated accuracy and precision in detecting and discerning L. monocytogenes from other Listeria species.

摘要

背景

GENE-UP® 李斯特菌 2（LMO 2）检测（经过性能验证的方法 121804）使用实时 PCR 技术和专有的检测平台 GENE-UP 热循环仪，以检测各种食品和环境表面中的李斯特菌。

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 采用为各种食品和选定环境表面中李斯特菌检测的第一行动官方方法。

方法

作为 AFNOR NF VALIDATION 认证过程的一部分，使用全脂山羊奶干酪（8.4%脂肪）的未配对测试部分，在多实验室研究中评估 GENE-UP 方法。候选方法与 ISO 11290-1/Amd.1:2004 参考方法进行比较。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：未接种对照水平（0 CFU/测试部分）、低接种体水平（∼2 CFU/测试部分）和高接种体水平（∼10 CFU/测试部分）。根据 AOAC 验证指南中提出的检测概率（POD）统计模型分析研究数据。