Validation of the Thermo Scientific™ SureTect™ Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus PCR Assay for the Detection of Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus in Seafood Matrixes: AOAC Performance Tested MethodsSM 022301.

IF 1.7 4区农林科学 Q3 CHEMISTRY, ANALYTICAL

Journal of AOAC International Pub Date : 2023-09-01 DOI:10.1093/jaoacint/qsad061

Nikki Faulds, Jessica Williams, Katharine Evans, Annette Hughes, Dean Leak, David Crabtree, Nicole Prentice, Daniele Sohier, Pauliina Heikkinen, Emmi Hurskainen, Wendy McMahon, Nicole Cuthbert, Bailey Matthews, Lydia Ruben, Luvie Sturghill, Frank Godawski

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引用次数: 1

Abstract

Background: The Thermo Scientific™ SureTect™ Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus PCR Assay method is a real-time PCR method for the multiplex detection of Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus in seafood.

Objective: The Thermo Scientific SureTect Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus Assay was evaluated for AOAC Performance Tested MethodsSM certification.

Method: Inclusivity/exclusivity, matrix, product consistency/stability, and robustness studies were conducted to assess the method's performance. For the matrix study, the method was validated using the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR Food Safety Instrument and the Applied Biosystems™ 7500 Fast Real-Time PCR Food Safety Instrument against the U.S. Food and Drug Administration Bacteriological Analytical Manual, Chapter 9 (2004), Vibrio and ISO 21872-1:2017 Microbiology of the food chain-Horizontal method for the determination of Vibrio spp.-Part 1: Detection of potentially enteropathogenic Vibrio parahaemolyticus, Vibrio cholerae, and Vibrio vulnificus reference methods.

Results: Matrix studies showed equivalent or superior performance of the candidate method compared to the reference method and, overall, no difference between presumptive and confirmed results, except for one matrix due to high background flora. The inclusivity/exclusivity study correctly identified/excluded all strains analyzed. Robustness testing showed no statistically significant differences in assay performance under varied test conditions. Product consistency and stability studies demonstrated no statistically significant differences between assay lots with different expiration dates.

Conclusions: The data presented show that the assay constitutes a rapid and reliable workflow for the detection of V. cholerae, V. parahaemolyticus, and V. vulnificus in seafood matrixes.

Highlights: The SureTect PCR Assay method allows for fast, reliable detection of stipulated strains in seafood matrixes with results obtained in as little as 80 min post-enrichment.

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Thermo Scientific™SureTect™霍乱弧菌、副溶血性弧菌和创伤弧菌PCR检测海产品基质中霍乱弧菌、副溶血性弧菌和创伤弧菌的验证:AOAC性能测试方法ssm 022301。

背景:Thermo Scientific™SureTect™霍乱弧菌、副溶血性弧菌和创伤弧菌PCR检测方法是一种用于海鲜中霍乱弧菌、副溶血性弧菌和创伤弧菌多重检测的实时PCR方法。目的:评价热科学检测霍乱弧菌、副溶血性弧菌和创伤弧菌的方法在AOAC性能检测方法ssm认证中的应用。方法:通过包容性/排他性、矩阵、产品一致性/稳定性和稳健性研究来评估方法的性能。对于矩阵研究，使用Applied Biosystems™QuantStudio™5实时荧光定量PCR食品安全仪器和Applied Biosystems™7500快速实时荧光定量PCR食品安全仪器，对照美国食品和药物管理局细菌学分析手册第9章(2004)，弧菌和ISO 21872-1:2017食物链微生物学-水平法测定弧菌-第1部分进行验证。检测潜在致病性副溶血性弧菌、霍乱弧菌和创伤弧菌的参考方法。结果:与参考方法相比，基质研究显示候选方法的性能相当或更好，总体而言，除了一个基质由于高背景菌群而没有差异外，推定结果和确认结果之间没有差异。包容性/排他性研究正确识别/排除了所有分析的菌株。鲁棒性检验显示，在不同的测试条件下，分析性能没有统计学上的显著差异。产品一致性和稳定性研究表明，不同有效期的测定批次之间没有统计学上的显著差异。结论:该方法可快速、可靠地检测海产品基质中的霍乱弧菌、副溶血性弧菌和创伤弧菌。SureTect PCR检测方法可以快速、可靠地检测海产品基质中规定的菌株，富集后只需80分钟即可获得结果。

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来源期刊

Journal of AOAC International 医学-分析化学

CiteScore

3.10

自引率

12.50%

发文量

144

审稿时长

2.7 months

期刊介绍： The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.